ISO/TC 210
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
59752 | ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes | Standarts spēkā |
65624 | IEC/TR 80002-3:2014 | Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304) | Standarts spēkā |
38421 | IEC 62304:2006 | Medical device software — Software life cycle processes | Standarts spēkā |
72704 | ISO 14971:2019 | Medical devices — Application of risk management to medical devices | Standarts spēkā |
60044 | ISO/TR 80002-2:2017 | Medical device software — Part 2: Validation of software for medical device quality systems | Standarts spēkā |
69729 | ISO 18250-7:2018 | Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion | Standarts spēkā |
69336 | ISO/TS 11633-1:2019 | Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis | Standarts spēkā |
65684 | ISO 18250-8:2018 | Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications | Standarts spēkā |
77326 | ISO 15223-1:2021 | Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements | Standarts spēkā |
50730 | ISO/DIS 80369-2 | Small bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for breathing systems and driving gases applications | Standarts spēkā |
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