Standards on Medical Devices Safety


Technical committee



Related standards or drafts

Standards package "Medical devices"

60.60 Standard published

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

60.60 Standard published

CEN/CLC/JTC 3

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)

60.60 Standard published

CEN/TC 102

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

90.60 Close of review

CEN/TC 140

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

60.60 Standard published

CEN/TC 140

General requirements for in vitro diagnostic medical devices for self-testing

90.93 Standard confirmed

CEN/TC 140

Performance evaluation of in vitro diagnostic medical devices

90.93 Standard confirmed

CEN/TC 140

Performance evaluation of in vitro diagnostic medical devices

60.60 Standard published

CEN/TC 140

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

60.60 Standard published

CEN/TC 239

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

90.93 Standard confirmed

CEN/TC 140

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

90.93 Standard confirmed

CEN/TC 205
CEN/CENELEC

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

90.93 Standard confirmed

CEN/CLC/JTC 3
CEN/CENELEC

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

90.93 Standard confirmed

CEN/CLC/JTC 3

Dentistry - Medical devices for dentistry - Instruments

90.60 Close of review

CEN/TC 55

Dentistry - Medical devices for dentistry - Equipment

90.60 Close of review

CEN/TC 55

Dentistry - Medical devices for dentistry - Materials

90.60 Close of review

CEN/TC 55

Dentistry - Medical devices for dentistry - Dental implants

90.92 Standard to be revised

CEN/TC 55

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

60.60 Standard published

CEN/CLC/JTC 16

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

60.60 Standard published

CEN/CLC/JTC 16

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

60.60 Standard published

CEN/CLC/JTC 16

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

60.60 Standard published

CEN/CLC/JTC 16

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

CEN/CLC/JTC 16

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

CEN/CLC/JTC 16

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

CEN/CLC/JTC 16

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

60.60 Standard published

CEN/CLC/JTC 16

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

60.60 Standard published

CEN/CLC/JTC 16

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General

90.93 Standard confirmed

CLC/TC 106X

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers

60.60 Standard published

CLC/TC 106X

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs)

90.93 Standard confirmed

CLC/TC 106X

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-3: Specific assessment for workers with implantable neurostimulators

60.60 Standard published

CLC/TC 106X

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

60.60 Standard published

CEN/TC 204

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

CEN/TC 204

Medical devices - Part 1: Application of usability engineering to medical devices

60.60 Standard published

CLC/TC 62

Medical devices - Part 1: Application of usability engineering to medical devices

60.60 Standard published

CLC/TC 62

Medical devices - Part 1: Application of usability engineering to medical devices

60.60 Standard published

CLC/TC 62

Medical devices - Part 1: Application of usability engineering to medical devices

60.60 Standard published

CLC/TC 62

Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

60.60 Standard published

CLC/TC 62

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

60.60 Standard published

CLC/TC 62

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

90.60 Close of review

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

90.92 Standard to be revised

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods

90.92 Standard to be revised

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

90.92 Standard to be revised

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

90.60 Close of review

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

90.92 Standard to be revised

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

90.92 Standard to be revised

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

90.60 Close of review

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

90.60 Close of review

CEN/TC 102

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

60.60 Standard published

CLC/TC 62

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

60.60 Standard published

CEN/TC 206

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

CEN/TC 206

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

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

60.60 Standard published

CEN/TC 206

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

CEN/TC 206

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

60.60 Standard published

CEN/TC 206

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

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

60.60 Standard published

CEN/TC 206

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

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

60.60 Standard published

CEN/TC 206

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

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

60.60 Standard published

CEN/TC 206

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

CEN/TC 206

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

60.60 Standard published

CEN/TC 206

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

60.60 Standard published

CEN/TC 204

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

60.60 Standard published

CEN/TC 204

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

CEN/TC 204

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

CEN/TC 204

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

CEN/TC 102

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

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)

60.60 Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

60.60 Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

60.60 Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)

60.60 Standard published

CEN/TC 102

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

60.60 Standard published

CEN/TC 204

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

60.60 Standard published

CEN/CLC/JTC 3

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

60.60 Standard published

CEN/CLC/JTC 3

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

60.60 Standard published

CEN/CLC/JTC 3

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

60.60 Standard published

CEN/CLC/JTC 3

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

60.60 Standard published

CEN/CLC/JTC 3

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

60.60 Standard published

CEN/CLC/JTC 3

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

60.60 Standard published

CEN/TC 206

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)

60.60 Standard published

CEN/TC 204

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)

60.60 Standard published

CEN/CLC/JTC 16

Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)

60.60 Standard published

CEN/CLC/JTC 16

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

CEN/TC 204

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

90.92 Standard to be revised

CEN/TC 140

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

90.93 Standard confirmed

CEN/TC 140

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

60.60 Standard published

CEN/CLC/JTC 3

Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)

60.60 Standard published

CEN/TC 102

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)

60.60 Standard published

CEN/TC 102

Systems for evacuation of plume generated by medical devices (ISO 16571:2024)

60.60 Standard published

CEN/TC 215

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)

60.60 Standard published

CEN/TC 215

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

60.60 Standard published

CEN/TC 140

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

60.60 Standard published

CEN/TC 204

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)

60.60 Standard published

CEN/TC 204

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)

60.60 Standard published

CEN/TC 140

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)

60.60 Standard published

CEN/TC 140

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)

60.60 Standard published

CEN/TC 140

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

60.60 Standard published

CEN/TC 140

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

60.60 Standard published

CEN/TC 140

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

90.93 Standard confirmed

CEN/TC 140

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

60.60 Standard published

CEN/TC 140

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)

60.60 Standard published

CEN/CLC/JTC 3

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)

60.60 Standard published

CEN/TC 204

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

60.60 Standard published

CEN/TC 140

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

60.60 Standard published

CEN/TC 206

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

60.60 Standard published

CEN/TC 206

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

CEN/TC 206

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

CEN/TC 205

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

60.60 Standard published

CEN/TC 140

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

CEN/TC 204

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)

60.60 Standard published

CEN/TC 204

In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

60.60 Standard published

CEN/TC 140

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

60.60 Standard published

CEN/TC 55

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

60.60 Standard published

CEN/TC 205

Medical devices — Part 1: Application of usability engineering to medical devices

90.93 Standard confirmed

ISO/TC 210

Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1

60.60 Standard published

ISO/TC 210

Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices

60.60 Standard published

TC 62/SC 62A

Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1

60.60 Standard published

ISO/TC 210

Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices

60.60 Standard published

TC 62/SC 62A

Medical devices - Part 1: Application of usability engineering to medical devices

60.60 Standard published

TC 62/SC 62A

Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

60.60 Standard published

TC 62/SC 62B

Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

60.60 Standard published

TC 62/SC 62A

Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

90.92 Standard to be revised

ISO/TC 210

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls

90.92 Standard to be revised

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices — Part 2-8: Application guidance — Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

90.92 Standard to be revised

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices — Part 2-9: Application guidance — Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities

60.60 Standard published

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

60.60 Standard published

TC 62/SC 62A

Biological evaluation of medical devices — Part 10: Tests for skin sensitization

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

90.92 Standard to be revised

ISO/TC 194

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

90.92 Standard to be revised

ISO/TC 194

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

90.60 Close of review

ISO/TC 194

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

90.60 Close of review

ISO/TC 194

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys

90.20 Standard under periodical review

ISO/TC 194

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

90.92 Standard to be revised

ISO/TC 194

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 2: Animal welfare requirements

90.92 Standard to be revised

ISO/TC 194

Biological evaluation of medical devices — Part 23: Tests for irritation

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

90.92 Standard to be revised

ISO/TC 194

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

90.93 Standard confirmed

ISO/TC 194

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

90.93 Standard confirmed

ISO/TC 194

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

90.92 Standard to be revised

ISO/TC 194

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

90.92 Standard to be revised

ISO/TC 194

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

90.20 Standard under periodical review

ISO/TC 194

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

90.92 Standard to be revised

ISO/TC 198

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release

60.60 Standard published

ISO/TC 198

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

90.92 Standard to be revised

ISO/TC 198

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1

60.60 Standard published

ISO/TC 198

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

60.60 Standard published

ISO/TC 198

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

90.93 Standard confirmed

ISO/TC 198

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management

60.60 Standard published

ISO/TC 198

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

90.93 Standard confirmed

ISO/TC 198

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management

60.60 Standard published

ISO/TC 198

Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products

90.93 Standard confirmed

ISO/TC 198

Medical devices — Quality management systems — Requirements for regulatory purposes

90.93 Standard confirmed

ISO/TC 210

Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

90.20 Standard under periodical review

ISO/TC 150/SC 6

Clinical investigation of medical devices for human subjects — Good clinical practice

90.92 Standard to be revised

ISO/TC 194

Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

60.60 Standard published

ISO/TC 198

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

90.92 Standard to be revised

ISO/TC 150/SC 6

Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers

90.20 Standard under periodical review

ISO/TC 150/SC 6

Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

90.92 Standard to be revised

ISO/TC 150/SC 6

Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems

60.60 Standard published

ISO/TC 150/SC 6

Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices

60.60 Standard published

ISO/TC 150/SC 6

Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

90.20 Standard under periodical review

ISO/TC 150/SC 6

Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems

90.20 Standard under periodical review

ISO/TC 150/SC 6

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

90.93 Standard confirmed

ISO/TC 198

Medical devices — Application of risk management to medical devices

90.20 Standard under periodical review

ISO/TC 210

Medical devices - Application of risk management to medical devices

60.60 Standard published

TC 62/SC 62A

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures

90.92 Standard to be revised

ISO/TC 212

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation

90.92 Standard to be revised

ISO/TC 212

Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

90.60 Close of review

ISO/TC 212

Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

60.60 Standard published

ISO/TC 210

Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

90.92 Standard to be revised

ISO/TC 210

Implants for surgery — Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices

90.93 Standard confirmed

ISO/TC 150/SC 1

Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment

90.92 Standard to be revised

ISO/TC 198

Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment

90.92 Standard to be revised

ISO/TC 198

Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices

90.92 Standard to be revised

ISO/TC 150/SC 1

Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods

90.93 Standard confirmed

ISO/TC 150/SC 1

Systems for evacuation of plume generated by medical devices

60.60 Standard published

ISO/TC 121/SC 6

Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

90.92 Standard to be revised

ISO/TC 121/SC 3

In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

60.60 Standard published

ISO/TC 212

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

60.60 Standard published

ISO/TC 212

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

60.60 Standard published

ISO/TC 198

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices

60.60 Standard published

ISO/TC 198

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

60.60 Standard published

ISO/TC 198

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials

90.60 Close of review

ISO/TC 212

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods

90.93 Standard confirmed

ISO/TC 210

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications

90.92 Standard to be revised

ISO/TC 210

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications

90.93 Standard confirmed

ISO/TC 210

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion

90.93 Standard confirmed

ISO/TC 210

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications

90.60 Close of review

ISO/TC 210

In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

90.93 Standard confirmed

ISO/TC 212

Medical devices — Information to be supplied by the manufacturer

90.92 Standard to be revised

ISO/TC 210

Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

90.93 Standard confirmed

ISO/TC 198

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

90.60 Close of review

ISO/TC 212

In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification

60.60 Standard published

ISO/TC 212

Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

60.60 Standard published

ISO/TC 198

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

60.60 Standard published

ISO/TC 194

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling

60.60 Standard published

ISO/TC 194

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

90.93 Standard confirmed

ISO/TC 194

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

90.92 Standard to be revised

ISO/TC 94/SC 13

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

90.92 Standard to be revised

ISO/TC 212

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices

90.93 Standard confirmed

ISO/TC 198

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1

60.60 Standard published

ISO/TC 198

Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements

90.92 Standard to be revised

ISO/TC 150/SC 6

Medical devices — Non-electrically driven portable infusion devices

60.60 Standard published

ISO/TC 76

In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood

60.60 Standard published

ISO/TC 76

Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

90.92 Standard to be revised

ISO/TC 106

Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods

90.92 Standard to be revised

ISO/TC 84

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

90.20 Standard under periodical review

ISO/TMBG

Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services

90.93 Standard confirmed

ISO/TC 215

Biological evaluation of medical devices — Part 22: Guidance on nanomaterials

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

60.60 Standard published

ISO/TC 194

Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity

60.60 Standard published

ISO/TC 194

Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 2: Implementation of an information security management system (ISMS)

60.60 Standard published

ISO/TC 215

Medical devices — Pump tube spallation test — General procedure

60.60 Standard published

ISO/TC 76

Medical devices — Post-market surveillance for manufacturers

60.60 Standard published

ISO/TC 210

Pyrogenicity — Principles and methods for pyrogen testing of medical devices

60.60 Standard published

ISO/TC 194

Health informatics — Use of mobile wireless communication and computing technology in healthcare facilities — Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices

60.60 Standard published

ISO/TC 215

Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

90.93 Standard confirmed

ISO/TC 194

Medical devices — Guidance on the application of ISO 14971

60.60 Standard published

ISO/TC 210

Medical devices - Guidance on the application of ISO 14971

60.60 Standard published

TC 62/SC 62A

Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants

60.60 Standard published

ISO/TC 194

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

90.60 Close of review

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

60.60 Standard published

TC 62/SC 62A

Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

90.60 Close of review

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

60.60 Standard published

TC 62/SC 62A

Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

90.93 Standard confirmed

ISO/TC 194

Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

90.20 Standard under periodical review

ISO/TC 194

Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis

90.92 Standard to be revised

ISO/TC 215

Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices

60.60 Standard published

ISO/TC 194

Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2

90.20 Standard under periodical review

ISO/TC 198

Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

90.93 Standard confirmed

ISO/TC 198

Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

90.93 Standard confirmed

ISO/TC 194

Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

90.93 Standard confirmed

ISO/TC 198

Medical devices — Transfusion set and blood bag compatibility test method

90.93 Standard confirmed

ISO/TC 76

Biological evaluation of absorbable medical devices — Part 1: General requirements

90.60 Close of review

ISO/TC 194