90/385/EEC

Active implantable 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 It may happen that a standard is withdrawn by the standardisation body and remains applicable in the context of the EU legislation, unless the reference is withdrawn from the official journal.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"

11 - Draft standards 67 - View all published standards related to this directive 170 - Withdrawn standards

Harmonised Standards or standards supporting the application of the EU legislation

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

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

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

60.60 Standard published

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

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

60.60 Standard published

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

60.60 Standard published

C 153 Official journal reference
Jun 24, 2005 Official journal publication date

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

99.60 Withdrawal effective

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

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

99.60 Withdrawal effective

C 153 Official journal reference
Jun 24, 2005 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

Information supplied by the manufacturer with medical devices

99.60 Withdrawal effective

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

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)

99.60 Withdrawal effective

C 153 Official journal reference
Jun 24, 2005 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 29002

99.60 Withdrawal effective

C 277 Official journal reference
Oct 4, 1994 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN 29001

99.60 Withdrawal effective

C 277 Official journal reference
Oct 4, 1994 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

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

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

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 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

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

90.92 Standard to be revised

C 173 Official journal reference
May 13, 2016 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 14 Official journal reference
Jan 16, 2015 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

Medical devices - Risk analysis

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

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

99.60 Withdrawal effective

C 149 Official journal reference
May 17, 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

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

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

99.60 Withdrawal effective

C 153 Official journal reference
Jun 24, 2005 Official journal publication date

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

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 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 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 4: Selection of tests for interactions with blood (ISO 10993-4:2002)

99.60 Withdrawal effective

C 153 Official journal reference
Jun 24, 2005 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 183 Official journal reference
Jul 7, 2010 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 149 Official journal reference
May 17, 1997 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 307 Official journal reference
Nov 18, 1995 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 277 Official journal reference
Oct 4, 1994 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 277 Official journal reference
Oct 4, 1994 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 277 Official journal reference
Oct 4, 1994 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 277 Official journal reference
Nov 15, 2006 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 16 Official journal reference
Jan 18, 2011 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 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

90.92 Standard to be revised

C 153 Official journal reference
Jun 24, 2005 Official journal publication date

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

99.60 Withdrawal effective

C 153 Official journal reference
Jun 24, 2005 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 149 Official journal reference
May 17, 1997 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 149 Official journal reference
May 17, 1997 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 307 Official journal reference
Nov 18, 1995 Official journal publication date

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

99.60 Withdrawal effective

C 277 Official journal reference
Oct 4, 1994 Official journal publication date

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

99.60 Withdrawal effective

C 277 Official journal reference
Oct 4, 1994 Official journal publication date

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

99.60 Withdrawal effective

C 277 Official journal reference
Oct 4, 1994 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

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 186 Official journal reference
Aug 9, 2007 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 14 Official journal reference
Jan 16, 2015 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 14 Official journal reference
Jan 16, 2015 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

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

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

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 186 Official journal reference
Aug 9, 2007 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

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

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

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

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

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 186 Official journal reference
Aug 9, 2007 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 277 Official journal reference
Nov 15, 2006 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 307 Official journal reference
Nov 18, 1995 Official journal publication date

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)

99.60 Withdrawal effective

C 153 Official journal reference
Jun 24, 2005 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 153 Official journal reference
Jun 24, 2005 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

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

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

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 186 Official journal reference
Aug 9, 2007 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 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

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

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

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 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

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

99.60 Withdrawal effective

C 153 Official journal reference
Jun 24, 2005 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 41 Official journal reference
Feb 19, 2009 Official journal publication date

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

60.60 Standard published

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

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

60.60 Standard published

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

60.60 Standard published

C 153 Official journal reference
Jun 24, 2005 Official journal publication date

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

99.60 Withdrawal effective

C 268 Official journal reference
Aug 27, 1998 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

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

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

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

99.60 Withdrawal effective

C 186 Official journal reference
Aug 9, 2007 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

Information supplied by the manufacturer with medical devices

99.60 Withdrawal effective

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

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)

99.60 Withdrawal effective

C 153 Official journal reference
Jun 24, 2005 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 29002

99.60 Withdrawal effective

C 277 Official journal reference
Oct 4, 1994 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN 29001

99.60 Withdrawal effective

C 277 Official journal reference
Oct 4, 1994 Official journal publication date

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

99.60 Withdrawal effective

C 153 Official journal reference
Jun 24, 2005 Official journal publication date

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

60.60 Standard published

C 22/01 Official journal reference
Jan 24, 2013 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 181 Official journal reference
Jun 26, 1999 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

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

60.60 Standard published

C 22/01 Official journal reference
Jan 24, 2013 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety

99.60 Withdrawal effective

C 123/01 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety

99.60 Withdrawal effective

C 123/01 Official journal reference
Apr 27, 2012 Official journal publication date

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

60.60 Standard published

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

Medical electrical equipment - Part 1: General requirements for safety

99.60 Withdrawal effective

C 123/01 Official journal reference
Apr 27, 2012 Official journal publication date

Medical device software - Software life-cycle processes

60.60 Standard published

C 22/01 Official journal reference
Jan 24, 2013 Official journal publication date

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

60.60 Standard published

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Medical electrical equipment - Part 1: General requirements for safety

99.60 Withdrawal effective

C 176 Official journal reference
Jul 8, 2004 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 devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 90 Official journal reference
Mar 25, 2020 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

L 90 Official journal reference
Mar 25, 2020 Official journal publication date

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

60.60 Standard published

OJ L 129 Official journal reference
Apr 15, 2021 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

L 90 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

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

60.60 Standard published

L 90 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

L 90 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

L 90 Official journal reference
Mar 25, 2020 Official journal publication date