ISO/TC 210
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
72704 | ISO 14971:2019 | Medical devices — Application of risk management to medical devices | Standarts spēkā |
69126 | IEC/TR 62366-2:2016 | Medical devices — Part 2: Guidance on the application of usability engineering to medical devices | Standarts spēkā |
86270 | ISO 15223-1:2021/Amd 1:2025 | 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 | Standarts spēkā |
72042 | IEC 62366-1:2015/Cor 1:2016 | Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1 | Standarts spēkā |
54146 | IEC/TR 80002-1:2009 | Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software | Standarts spēkā |
60044 | ISO/TR 80002-2:2017 | Medical device software — Part 2: Validation of software for medical device quality systems | Standarts spēkā |
38421 | IEC 62304:2006 | Medical device software — Software life cycle processes | Standarts spēkā |
67943 | ISO 20417:2021 | Medical devices — Information to be supplied by the manufacturer | Standarts spēkā |
42343 | ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation | Standarts spēkā |
67944 | ISO/IEC Guide 63:2019 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices | Standarts spēkā |
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