Projects and standards

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

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)

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 - 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

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

90.60 Close of review

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

60.60 Standard published

Amendment 1 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

60.60 Standard published

Amendment 2 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

60.60 Standard published

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

60.60 Standard published

Amendment 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

60.60 Standard published

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

60.60 Standard published

Amendment 1 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

60.60 Standard published

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

60.60 Standard published

Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

60.60 Standard published

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

60.60 Standard published

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

60.60 Standard published

Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

60.60 Standard published