93/42/EEC

Medical devices

This web page provides you with updated information on the European standard supporting the implementation of EU Directives and regulations. It provides, on one hand the information corresponding to the real-time status of the standards provided by CEN and CENELEC and, on the other hand, provides updated information about the status of the standards in support of the European legislation. It may happen that a standard is withdrawn by the standardisation body and remains applicable in the context of the EU legislation, unless the reference is withdrawn from the official journal.

"DISCLAIMER: This is an informative page, providing added value information on standards. Information may evolve and change subject to the publication of other legislative texts. This page has no legal validity and only informative value. Genorma.com informs its users that users of this platform are responsible for deciding the version of the standard that is applicable to their products, and not Genorma.com. As a consequence, Genorma.com users are encouraged to check the latest versions of the legal text accessible through the EUR-LEX website or the Website of the European Commission"

113 - Draft standards 423 - View all published standards related to this directive 756 - Withdrawn standards

Harmonised Standards or standards supporting the application of the EU legislation

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Dentistry - Medical devices for dentistry - Equipment

90.60 Close of review

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Dentistry - Medical devices for dentistry - Materials

90.60 Close of review

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Dentistry - Medical devices for dentistry - Instruments

90.60 Close of review

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Respiratory therapy equipment - Part 3: Air entrainment devices

90.92 Standard to be revised

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Respiratory therapy equipment - Part 2: Tubing and connectors

90.93 Standard confirmed

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)

60.60 Standard published

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

90.60 Close of review

C 226 Official journal reference
Jul 10, 2015 Official journal publication date

Catheters other than intravascular catheters - Test methods for common properties

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

60.60 Standard published

C 22 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

60.60 Standard published

C 22 Official journal reference
Jan 24, 2013 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 83 Official journal reference
Apr 2, 2004 Official journal publication date

Graphical symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 83 Official journal reference
Apr 2, 2004 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Information supplied by the manufacturer with medical devices

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements

99.60 Withdrawal effective

C 186 Official journal reference
Jul 23, 2008 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Information supplied by the manufacturer of medical devices

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 186 Official journal reference
Jul 23, 2008 Official journal publication date

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

90.60 Close of review

C 143 Official journal reference
May 13, 2011 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

99.60 Withdrawal effective

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

99.60 Withdrawal effective

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

90.60 Close of review

C 173 Official journal reference
May 13, 2016 Official journal publication date

Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Medical gloves for single use - Part 2: Requirements and testing for physical properties

99.60 Withdrawal effective

C 149 Official journal reference
May 16, 2014 Official journal publication date

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

99.60 Withdrawal effective

C 149 Official journal reference
May 16, 2014 Official journal publication date

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)

99.60 Withdrawal effective

C 226 Official journal reference
Jul 10, 2015 Official journal publication date

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)

99.60 Withdrawal effective

C 226 Official journal reference
Jul 10, 2015 Official journal publication date

Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)

99.60 Withdrawal effective

C 268 Official journal reference
Nov 7, 2003 Official journal publication date

Medical devices - Risk analysis

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Transportable gas cylinders - Cylinder identification - Part 3: Colour coding

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

High-pressure flexible connections for use with medical gases

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Respiratory therapy equipment - Part 1: Nebulizing systems and their components

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Respiratory therapy equipment - Part 3: Air entrainment devices

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical suction equipment - Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999)

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Connections for gas sampling tubes to anaesthetic and respiratory equipment

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Flow-metering devices for connection to terminal units of medical gas pipeline systems

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Rail systems for supporting medical equipment

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Oxygen monitors for patient breathing mixtures - Particular requirements

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Medical suction equipment - Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1992)

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1992)

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Tracheostomy tubes - Part 2: Pediatric tubes

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Humidifiers for medical use - General requirements for humidification systems (ISO 8185:1997)

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Anaesthetic gas monitors (ISO 11196:1995 including Technical Corrigendum 1:1997)

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Agent specific filling systems for anaesthetic vaporizers - Part 1: Rectangular keyed filling systems

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Lung ventilators - Part 2: Particular requirements for home care use

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Lung ventilators - Part 1: Particular requirements for critical care ventilators

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Particular requirements for safety of medical supply units

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Low-pressure hose assemblies for use with medical gases

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1991, including Technical Corrigendum 1:1992 and Technical Corrigendum 2:1993)

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Pulse oximeters - Particular requirements

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Medical electrical equipment - Capnometers for use with humans - Particular requirements

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Breathing tubes intended for use with anaesthetic apparatus and ventilators

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Anaesthesiology - Vocabulary (ISO 4135:1995)

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Anaesthetic reservoir bags

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Tracheal tubes and connectors

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Anaesthetic workstations and their modules - Particular requirements

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes for use in adults

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified)

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Laryngoscopes for tracheal intubation - Particular requirements

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans - Technical Corrigendum 1 (ISO 26782:2009/Cor 1:2009)

60.60 Standard published

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Sterilization - Steam sterilizers - Large sterilizers

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

99.60 Withdrawal effective

C 268 Official journal reference
Nov 7, 2003 Official journal publication date

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

99.60 Withdrawal effective

C 186 Official journal reference
Jul 23, 2008 Official journal publication date

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick test

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Sterilization - Steam sterilizers - Large sterilizers

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

60.60 Standard published

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Small steam sterilizers

99.60 Withdrawal effective

C 226 Official journal reference
Jul 10, 2015 Official journal publication date

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Concentrates for haemodialysis and related therapies

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

External limb prostheses and external orthoses - Requirements and test methods

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Adjustable beds for disabled persons - Requirements and test methods

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Electrically powered wheelchairs, scooters and their charges - Requirements and test methods

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Manually propelled wheelchairs - Requirements and test methods

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Walking aids - General requirements and test methods

90.93 Standard confirmed

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Technical aids for disabled persons - General requirements and test methods

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006/Cor 1:2007)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)

99.60 Withdrawal effective

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

99.60 Withdrawal effective

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

99.60 Withdrawal effective

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

60.60 Standard published

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

60.60 Standard published

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

60.60 Standard published

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Breathing tubes intended for use with anaesthetic apparatus and ventilators

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Small steam sterilizers

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

99.60 Withdrawal effective

C 270 Official journal reference
Nov 11, 2003 Official journal publication date

Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

99.60 Withdrawal effective

C 288 Official journal reference
Oct 9, 1999 Official journal publication date

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

60.60 Standard published

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:1996)

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994)

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:1992)

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:1993)

99.60 Withdrawal effective

C 338 Official journal reference
Nov 8, 1997 Official journal publication date

Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization (ISO 10993-10:1995)

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992)

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - in vitro methods (ISO 10993-5:1992)

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

90.60 Close of review

C 268 Official journal reference
Nov 7, 2003 Official journal publication date

Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings

90.93 Standard confirmed

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Test methods for primary wound dressings - Part 1: Aspects of absorbency

90.93 Standard confirmed

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

60.60 Standard published

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

90.60 Close of review

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device

90.60 Close of review

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Small steam sterilizers

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Ophthalmic optics - Specifications for ready-to-wear spectacles

60.60 Standard published

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

60.60 Standard published

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995)

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Natural rubber latex male condoms

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Medical gloves for single use - Part 2: Requirements and testing for physical properties

99.60 Withdrawal effective

C 307 Official journal reference
Nov 18, 1995 Official journal publication date

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

99.60 Withdrawal effective

C 307 Official journal reference
Nov 18, 1995 Official journal publication date

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

90.93 Standard confirmed

C 307 Official journal reference
Nov 18, 1995 Official journal publication date

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)

99.60 Withdrawal effective

C 307 Official journal reference
Nov 18, 1995 Official journal publication date

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

60.60 Standard published

C 277 Official journal reference
Nov 15, 2006 Official journal publication date

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

99.60 Withdrawal effective

C 288 Official journal reference
Oct 9, 1999 Official journal publication date

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

90.20 Standard under periodical review

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Sterilization of medical devices - Validation and routine control of sterilization by moist heat

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

60.60 Standard published

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Dentistry - Medical devices for dentistry - Dental implants

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)

60.60 Standard published

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Non-active surgical implants - General requirements (ISO 14630:2008)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices

60.60 Standard published

C 277 Official journal reference
Nov 15, 2006 Official journal publication date

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Test methods for primary wound dressings - Part 1: Aspects of absorbency

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

90.60 Close of review

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008/Amd 1:2013)

99.60 Withdrawal effective

C 149 Official journal reference
May 16, 2014 Official journal publication date

Non-invasive sphygmomanometers - Part 1: General requirements

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd 1:2013)

99.60 Withdrawal effective

C 149 Official journal reference
May 16, 2014 Official journal publication date

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

60.60 Standard published

C 186 Official journal reference
Jul 23, 2008 Official journal publication date

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)

60.60 Standard published

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Rescue systems - Transportation of incubators - Part 2: System requirements

99.60 Withdrawal effective

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Rescue systems - Transportation of incubators - Part 1: Interface conditions

99.60 Withdrawal effective

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2002/Amd 1:2006)

99.60 Withdrawal effective

C 277 Official journal reference
Nov 15, 2006 Official journal publication date

Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)

60.60 Standard published

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

60.60 Standard published

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)

60.60 Standard published

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

99.60 Withdrawal effective

C 163 Official journal reference
Jul 15, 2009 Official journal publication date

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical gloves for single use - Part 2: Requirements and testing for physical properties

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

99.60 Withdrawal effective

C 22 Official journal reference
Jan 24, 2013 Official journal publication date

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)

60.60 Standard published

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)

99.60 Withdrawal effective

C 186 Official journal reference
Jul 23, 2008 Official journal publication date

Rail systems for supporting medical equipment (ISO 19054:2005)

90.92 Standard to be revised

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Clinical investigation of medical devices for human subjects - Good clinical practice - Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011)

99.60 Withdrawal effective

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 2 (ISO 7396-1:2007/Amd 2:2010)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Manual wheelchairs - Requirements and test methods

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)

99.60 Withdrawal effective

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Plastic containers for intravenous injections (ISO 15747:2010)

99.60 Withdrawal effective

C 123 Official journal reference
Apr 27, 2012 Official journal publication date

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

60.60 Standard published

C 123 Official journal reference
Apr 27, 2012 Official journal publication date

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

60.60 Standard published

C 123 Official journal reference
Apr 27, 2012 Official journal publication date

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

99.60 Withdrawal effective

C 123 Official journal reference
Apr 27, 2012 Official journal publication date

Dentistry - Medical devices for dentistry - Dental implants

90.92 Standard to be revised

C 149 Official journal reference
May 16, 2014 Official journal publication date

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

60.60 Standard published

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical vehicles and their equipment - Road ambulances

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

99.60 Withdrawal effective

C 277 Official journal reference
Nov 15, 2006 Official journal publication date

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

99.60 Withdrawal effective

C 277 Official journal reference
Nov 15, 2006 Official journal publication date

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)

90.92 Standard to be revised

C 277 Official journal reference
Nov 15, 2006 Official journal publication date

Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)

90.93 Standard confirmed

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Surgical masks - Requirements and test methods

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Anaesthesia and respiratory care alarm signals - Part 3: Guidance on application of alarms (ISO 9703-3:1998)

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Medical devices - Electrically-generated alarm signals

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

99.60 Withdrawal effective

C 270 Official journal reference
Nov 11, 2003 Official journal publication date

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

99.60 Withdrawal effective

C 270 Official journal reference
Nov 11, 2003 Official journal publication date

Clinical investigation of medical devices for human subjects

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Graphical symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Dentistry - Medical devices for dentistry - Dental implants

99.60 Withdrawal effective

C 240 Official journal reference
Sep 30, 2005 Official journal publication date

Dentistry - Medical devices for dentistry - Materials

99.60 Withdrawal effective

C 240 Official journal reference
Sep 30, 2005 Official journal publication date

Dentistry - Medical devices for dentistry - Equipment

99.60 Withdrawal effective

C 240 Official journal reference
Sep 30, 2005 Official journal publication date

Dentistry - Medical devices for dentistry - Instruments

99.60 Withdrawal effective

C 240 Official journal reference
Sep 30, 2005 Official journal publication date

Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing

90.60 Close of review

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Medical vehicles and their equipment - Road ambulances

99.60 Withdrawal effective

C 268 Official journal reference
Nov 7, 2003 Official journal publication date

Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)

90.93 Standard confirmed

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)

90.60 Close of review

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

90.60 Close of review

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

90.60 Close of review

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2003)

99.60 Withdrawal effective

C 268 Official journal reference
Nov 7, 2003 Official journal publication date

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements

99.60 Withdrawal effective

C 293 Official journal reference
Oct 14, 2000 Official journal publication date

Lung ventilators - Part 1: Particular requirements for critical care ventilators

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Instrumentation to be used in association with non-active surgical implants - General requirements

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Rescue systems - Transportation of incubators - Part 2: System requirements

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Rescue systems - Transportation of incubators - Part 1: Interface conditions

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Dentistry - Medical devices for dentistry - Dental implants

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Dentistry - Medical devices for dentistry - Instruments

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Dentistry - Medical devices for dentistry - Materials

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Dentistry - Medical devices for dentistry - Equipment

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 1997 Official journal publication date

Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Non-active surgical implants - Joint replacement implants - Particular requirements

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Non-active surgical implants - General requirements (ISO 14630:1997)

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

99.60 Withdrawal effective

C 277 Official journal reference
Nov 15, 2006 Official journal publication date

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

99.60 Withdrawal effective

C 277 Official journal reference
Nov 15, 2006 Official journal publication date

Medical gloves - Determination of removable surface powder (ISO 21171:2006)

60.60 Standard published

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)

99.60 Withdrawal effective

C 268 Official journal reference
Nov 7, 2003 Official journal publication date

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:1999, modified)

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997)

99.60 Withdrawal effective

C 181 Official journal reference
Jun 26, 1999 Official journal publication date

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:1997)

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Ophthalmic optics - Spectacle frames - General requirements and test methods (ISO 12870:1997)

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:1997)

99.60 Withdrawal effective

C 144 Official journal reference
May 9, 1998 Official journal publication date

Respiratory therapy equipment - Part 1: Nebulizing systems and their components

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Rescue systems - Transportation of incubators - Part 2: System requirements

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

60.60 Standard published

C 226 Official journal reference
Jul 10, 2015 Official journal publication date

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair

90.92 Standard to be revised

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sterilization - Steam sterilizers - Large sterilizers

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002/Cor 2:2008)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 1: Requirements for terminal units for vacuum fitted on medical supply units with operator-adjustable portions and connected to the pipeline through flexible hoses (ISO 7396-1:2007/Amd 1:2010)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1 (ISO 10993-10:2002/Amd 1:2006)

99.60 Withdrawal effective

C 277 Official journal reference
Nov 15, 2006 Official journal publication date

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Non-active surgical implants - General requirements (ISO 14630:2008)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006/Cor 1:2009)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)

60.60 Standard published

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Sterilization - Steam sterilizers - Large sterilizers

99.60 Withdrawal effective

C 163 Official journal reference
Jul 15, 2009 Official journal publication date

High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)

60.60 Standard published

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Respiratory therapy equipment - Part 1: Nebulizing systems and their components

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Lung ventilators - Part 1: Particular requirements for critical care ventilators

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

60.60 Standard published

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Medical supply units (ISO 11197:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

60.60 Standard published

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Patient handling equipment used in road ambulances - Part 5: Stretcher support

90.92 Standard to be revised

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Medical electrical equipment - Dose area product meters

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

60.60 Standard published

C 22 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

60.60 Standard published

C 22 Official journal reference
Jan 24, 2013 Official journal publication date

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

99.60 Withdrawal effective

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

99.60 Withdrawal effective

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements

99.60 Withdrawal effective

C 186 Official journal reference
Jul 23, 2008 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Information supplied by the manufacturer of medical devices

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 186 Official journal reference
Jul 23, 2008 Official journal publication date

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

90.60 Close of review

C 143 Official journal reference
May 13, 2011 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 83 Official journal reference
Apr 2, 2004 Official journal publication date

Graphical symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 83 Official journal reference
Apr 2, 2004 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Information supplied by the manufacturer with medical devices

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001

99.60 Withdrawal effective

C 245 Official journal reference
Aug 23, 1996 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source

99.60 Withdrawal effective

C 143/02 Official journal reference
May 13, 2011 Official journal publication date

Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems

99.60 Withdrawal effective

C 173/2 Official journal reference
Jul 26, 2006 Official journal publication date

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment

99.60 Withdrawal effective

C 16/02 Official journal reference
Jan 18, 2011 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of radiotherapy simulators

99.60 Withdrawal effective

C 288 Official journal reference
Oct 9, 1999 Official journal publication date

Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

99.60 Withdrawal effective

C 242/02 Official journal reference
Aug 19, 2011 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems

99.60 Withdrawal effective

C 247 Official journal reference
Oct 15, 2003 Official journal publication date

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of radiotherapy simulators

99.60 Withdrawal effective

C 288 Official journal reference
Oct 9, 1999 Official journal publication date

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of electroencephalographs

99.60 Withdrawal effective

C 14 Official journal reference
Jan 19, 2006 Official journal publication date

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry

99.60 Withdrawal effective

C 247 Official journal reference
Oct 15, 2003 Official journal publication date

Medical devices - Application of usability engineering to medical devices

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of high frequency surgical equipment

99.60 Withdrawal effective

C 247 Official journal reference
Oct 15, 2003 Official journal publication date

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical device software - Software life-cycle processes

60.60 Standard published

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Audiometers - Part 2: Equipment for speech audiometry

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

99.60 Withdrawal effective

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Radiotherapy equipment - Coordinates, movements and scales

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

99.60 Withdrawal effective

C 242/02 Official journal reference
Aug 19, 2011 Official journal publication date

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

99.60 Withdrawal effective

C 242/02 Official journal reference
Aug 19, 2011 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source

99.60 Withdrawal effective

C 143/02 Official journal reference
May 13, 2011 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

99.60 Withdrawal effective

C 183/03 Official journal reference
Jul 7, 2010 Official journal publication date

Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators

99.60 Withdrawal effective

C 242/02 Official journal reference
Aug 19, 2011 Official journal publication date

Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment

60.60 Standard published

C 173/2 Official journal reference
Jul 26, 2006 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of transcutaneous partial pressure monitoring equipment

99.60 Withdrawal effective

C 310 Official journal reference
Dec 13, 2002 Official journal publication date

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

99.60 Withdrawal effective

C 262/02 Official journal reference
Aug 30, 2012 Official journal publication date

Determination of the permanent filtration of X-ray tube assemblies

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

99.60 Withdrawal effective

C 165 Official journal reference
Jul 8, 2004 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems

99.60 Withdrawal effective

C 247 Official journal reference
Oct 15, 2003 Official journal publication date

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

60.60 Standard published

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment

99.60 Withdrawal effective

C 242/02 Official journal reference
Aug 19, 2011 Official journal publication date

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

99.60 Withdrawal effective

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use

99.60 Withdrawal effective

C 262/02 Official journal reference
Aug 30, 2012 Official journal publication date

Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Audiometers - Part 4: Equipment for extended high-frequency audiometry

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Radiotherapy equipment - Coordinates, movements and scales

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis

99.60 Withdrawal effective

C 262/02 Official journal reference
Aug 30, 2012 Official journal publication date

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

99.60 Withdrawal effective

C 183/03 Official journal reference
Jul 7, 2010 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors

99.60 Withdrawal effective

C 173/2 Official journal reference
Jul 26, 2006 Official journal publication date

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids

99.60 Withdrawal effective

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of transport incubators

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

60.60 Standard published

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

60.60 Standard published

C 149 Official journal reference
May 16, 2014 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of infant radiant warmers

99.60 Withdrawal effective

C 242/02 Official journal reference
Aug 19, 2011 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and tests

99.60 Withdrawal effective

C 165 Official journal reference
Jul 8, 2004 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of infant radiant warmers

99.60 Withdrawal effective

C 242/02 Official journal reference
Aug 19, 2011 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment

99.60 Withdrawal effective

C 173/2 Official journal reference
Jul 26, 2006 Official journal publication date

Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

99.60 Withdrawal effective

C 183/03 Official journal reference
Jul 7, 2010 Official journal publication date

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators

99.60 Withdrawal effective

C 242/02 Official journal reference
Aug 19, 2011 Official journal publication date

Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

99.60 Withdrawal effective

C 293/39 Official journal reference
Dec 2, 2009 Official journal publication date

Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of direct blood pressure monitoring equipment

99.60 Withdrawal effective

C 247 Official journal reference
Oct 15, 2003 Official journal publication date

Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical device software - Software life-cycle processes

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Radiotherapy equipment - Coordinates, movements and scales

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

99.60 Withdrawal effective

C 123/02 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment

99.60 Withdrawal effective

C 173/2 Official journal reference
Jul 26, 2006 Official journal publication date

Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

99.60 Withdrawal effective

C 165 Official journal reference
Jul 8, 2004 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety

99.60 Withdrawal effective

C 314/28 Official journal reference
Dec 22, 2007 Official journal publication date

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Audiometers - Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes

99.60 Withdrawal effective

C 293/39 Official journal reference
Dec 2, 2009 Official journal publication date

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

99.60 Withdrawal effective

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

60.60 Standard published

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Hearing aids - Part 13: Electromagnetic compatibility (EMC)

99.60 Withdrawal effective

C 314/28 Official journal reference
Dec 22, 2007 Official journal publication date

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Radiotherapy equipment - Coordinates, movements and scales

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Audiometers - Part 1: Pure-tone audiometers

99.60 Withdrawal effective

C 165 Official journal reference
Jul 8, 2004 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment

99.60 Withdrawal effective

C 314/28 Official journal reference
Dec 22, 2007 Official journal publication date

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

60.60 Standard published

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators

99.60 Withdrawal effective

C 242/02 Official journal reference
Aug 19, 2011 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

99.60 Withdrawal effective

C 22/02 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment

99.60 Withdrawal effective

C 310 Official journal reference
Dec 13, 2002 Official journal publication date

Medical face masks - Requirements and test methods

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

90.60 Close of review

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

LI 90/25 Official journal reference
Mar 25, 2020 Official journal publication date

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Medical vehicles and their equipment - Road ambulances

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Plastic containers for intravenous injections (ISO 15747:2018)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2017)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Rescue systems - Transportation of incubators - Part 2: System requirements

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

99.60 Withdrawal effective

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

60.60 Standard published

LI 90/1 Official journal reference
Mar 25, 2020 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

LI 90/25 Official journal reference
Mar 25, 2020 Official journal publication date

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date