Registration number (WIID)Project No.TitleStatus
65624IEC/TR 80002-3:2014Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)Standarts spēkā
38421IEC 62304:2006Medical device software — Software life cycle processesStandarts spēkā
67944ISO/IEC Guide 63:2019Guide to the development and inclusion of aspects of safety in International Standards for medical devicesStandarts spēkā
72704ISO 14971:2019Medical devices — Application of risk management to medical devicesStandarts spēkā
60044ISO/TR 80002-2:2017Medical device software — Part 2: Validation of software for medical device quality systemsStandarts spēkā
86270ISO 15223-1:2021/Amd 1:2025Medical 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 specificStandarts spēkā
69729ISO 18250-7:2018Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusionStandarts spēkā
54146IEC/TR 80002-1:2009Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device softwareStandarts spēkā
69731ISO 18250-6:2019Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applicationsStandarts spēkā
65684ISO 18250-8:2018Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applicationsStandarts spēkā
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