Registration number (WIID)Project No.TitleStatus
59752ISO 13485:2016Medical devices — Quality management systems — Requirements for regulatory purposesStandarts spēkā
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
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
69729ISO 18250-7:2018Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusionStandarts spēkā
69336ISO/TS 11633-1:2019Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysisStandarts spēkā
65684ISO 18250-8:2018Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applicationsStandarts spēkā
77326ISO 15223-1:2021Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirementsStandarts spēkā
50730ISO/DIS 80369-2Small bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for breathing systems and driving gases applicationsStandarts spēkā
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