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Medical devices — Quality management systems — Requirements for regulatory purposes
90.93 Standard confirmed
Medical devices — Application of risk management to medical devices
90.93 Standard confirmed
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
60.60 Standard published
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
90.20 Standard under periodical review
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
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
90.93 Standard confirmed
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications
90.93 Standard confirmed
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications
90.93 Standard confirmed
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion
90.93 Standard confirmed
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications
90.93 Standard confirmed
Medical devices — Post-market surveillance for manufacturers
90.92 Standard to be revised
Medical devices — Information to be supplied by the manufacturer
60.60 Standard published
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
60.60 Standard published
Medical devices — Guidance on the application of ISO 14971
90.92 Standard to be revised
Medical device maintenance management programme for healthcare delivery organizations (HDO)
60.60 Standard published
Medical device software — Part 2: Validation of software for medical device quality systems
60.60 Standard published
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
60.60 Standard published
Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications
60.60 Standard published
