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Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
60.60 Standard published
Medical devices — Quality management systems — Requirements for regulatory purposes
90.93 Standard confirmed
Medical devices — Application of risk management to medical devices
60.60 Standard published
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 information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific
40.00 DIS registered
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
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
90.93 Standard confirmed
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) — Amendment 1: Climate action changes
60.60 Standard published
Guidance for assessment and evaluation of changes to drug delivery systems
60.60 Standard published
Medical devices — Information to be supplied by the manufacturer
90.92 Standard to be revised
Medical devices — Information to be supplied by the manufacturer
30.99 CD approved for registration as DIS
Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
60.60 Standard published
Medical devices — Post-market surveillance for manufacturers
60.60 Standard published
Medical devices — Guidance on the application of ISO 14971
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 — 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
Medical device software — Part 2: Validation of software for medical device quality systems
60.60 Standard published
