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Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
60.60 Standard published
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
60.60 Standard published
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
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
90.20 Standard under periodical review
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
60.60 Standard published
General requirements for in vitro diagnostic medical devices for self-testing
90.93 Standard confirmed
Performance evaluation of in vitro diagnostic medical devices
90.93 Standard confirmed
Performance evaluation of in vitro diagnostic medical devices
60.60 Standard published
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
60.60 Standard published
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
90.93 Standard confirmed
Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
90.93 Standard confirmed
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
90.93 Standard confirmed
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
90.93 Standard confirmed
Dentistry - Medical devices for dentistry - Dental implants
90.92 Standard to be revised
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
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
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
60.60 Standard published
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
60.60 Standard published
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
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
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
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
60.60 Standard published
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
60.60 Standard published
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
90.93 Standard confirmed
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
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
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
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
Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
60.60 Standard published
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
Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
90.20 Standard under periodical review
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
90.92 Standard to be revised
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
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
90.92 Standard to be revised
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
90.20 Standard under periodical review
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
90.92 Standard to be revised
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
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
90.20 Standard under periodical review
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
90.20 Standard under periodical review
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
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
60.60 Standard published
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
60.60 Standard published
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
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
60.60 Standard published
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
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
60.60 Standard published
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
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
60.60 Standard published
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
60.60 Standard published
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
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
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
60.60 Standard published
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
60.60 Standard published
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
60.60 Standard published
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
60.60 Standard published
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
60.60 Standard published
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
60.60 Standard published
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
60.60 Standard published
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
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
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
60.60 Standard published
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
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
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
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
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
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
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
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
60.60 Standard published
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
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
60.60 Standard published
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
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
60.60 Standard published
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
60.60 Standard published
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
60.60 Standard published
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
60.60 Standard published
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
60.60 Standard published
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
60.60 Standard published
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
60.60 Standard published
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
60.60 Standard published
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
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
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
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
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
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
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
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
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
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
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
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
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
60.60 Standard published
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)
60.60 Standard published
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
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
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
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
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
60.60 Standard published
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
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
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
60.60 Standard published
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
60.60 Standard published
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
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
60.60 Standard published
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
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
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
60.60 Standard published
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
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
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
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
60.60 Standard published
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
60.60 Standard published
Medical devices — Part 1: Application of usability engineering to medical devices
90.93 Standard confirmed
Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
60.60 Standard published
Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1
60.60 Standard published
Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
60.60 Standard published
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
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
Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
90.92 Standard to be revised
Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
60.60 Standard published
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
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
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
Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
60.60 Standard published
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
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
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
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
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
60.60 Standard published
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
90.92 Standard to be revised
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
90.92 Standard to be revised
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
60.60 Standard published
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
90.20 Standard under periodical review
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
90.20 Standard under periodical review
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
60.60 Standard published
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
90.92 Standard to be revised
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
60.60 Standard published
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
60.60 Standard published
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
Biological evaluation of medical devices — Part 2: Animal welfare requirements
90.92 Standard to be revised
Biological evaluation of medical devices — Part 23: Tests for irritation
60.60 Standard published
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
90.92 Standard to be revised
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
90.93 Standard confirmed
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
90.93 Standard confirmed
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
90.92 Standard to be revised
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
90.92 Standard to be revised
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
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1
60.60 Standard published
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
60.60 Standard published
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
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
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
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
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
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
90.20 Standard under periodical review
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
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
90.20 Standard under periodical review
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
Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
90.93 Standard confirmed
Medical devices — Quality management systems — Requirements for regulatory purposes
90.93 Standard confirmed
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
60.60 Standard published
Clinical investigation of medical devices for human subjects — Good clinical practice
90.92 Standard to be revised
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
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
Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
60.60 Standard published
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
90.93 Standard confirmed
Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
60.60 Standard published
Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
60.60 Standard published
Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
60.60 Standard published
Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems
60.60 Standard published
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
Medical devices — Application of risk management to medical devices
60.60 Standard published
Medical devices - Application of risk management to medical devices
60.60 Standard published
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
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
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
90.60 Close of review
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
60.60 Standard published
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
Implants for surgery — Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
90.20 Standard under periodical review
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
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
Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
90.20 Standard under periodical review
Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
90.20 Standard under periodical review
Systems for evacuation of plume generated by medical devices
60.60 Standard published
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
90.92 Standard to be revised
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
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
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
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
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
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
60.60 Standard published
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
60.60 Standard published
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
60.60 Standard published
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
60.60 Standard published
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
60.60 Standard published
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
90.20 Standard under periodical review
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
90.60 Close of review
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications
90.92 Standard to be revised
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications
90.20 Standard under periodical review
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion
90.60 Close of review
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications
90.60 Close of review
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
90.93 Standard confirmed
Medical devices — Information to be supplied by the manufacturer
90.92 Standard to be revised
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
In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
90.20 Standard under periodical review
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
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
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
60.60 Standard published
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
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
60.60 Standard published
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
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
90.60 Close of review
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
90.92 Standard to be revised
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
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
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
90.92 Standard to be revised
Medical devices — Non-electrically driven portable infusion devices
60.60 Standard published
In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood
60.60 Standard published
Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
90.92 Standard to be revised
Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
90.93 Standard confirmed
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
60.60 Standard published
Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services
90.60 Close of review
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
60.60 Standard published
Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
60.60 Standard published
Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
60.60 Standard published
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
Medical devices — Pump tube spallation test — General procedure
60.60 Standard published
Medical devices — Post-market surveillance for manufacturers
60.60 Standard published
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
60.60 Standard published
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
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
Medical devices — Guidance on the application of ISO 14971
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971
60.60 Standard published
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
90.20 Standard under periodical review
Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
60.60 Standard published
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
90.20 Standard under periodical review
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
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
90.93 Standard confirmed
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
90.93 Standard confirmed
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
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
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
60.60 Standard published
Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
90.60 Close of review
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
90.93 Standard confirmed
Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
90.20 Standard under periodical review
Medical devices — Transfusion set and blood bag compatibility test method
90.93 Standard confirmed
Biological evaluation of absorbable medical devices — Part 1: General requirements
90.20 Standard under periodical review