Registration number (WIID)Project No.TitleStatus
33752ISO/TR 14969:2004Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003Atcelts
42343ISO 15223-2:2010Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validationStandarts spēkā
79173ISO 80369-7:2021Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applicationsStandarts spēkā
72704ISO 14971:2019Medical devices — Application of risk management to medical devicesStandarts 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
64686IEC 62304:2006/Amd 1:2015Medical device software — Software life cycle processes — Amendment 1Standarts spēkā
60044ISO/TR 80002-2:2017Medical device software — Part 2: Validation of software for medical device quality systemsStandarts spēkā
59752ISO 13485:2016Medical devices — Quality management systems — Requirements for regulatory purposesStandarts spēkā
67943ISO 20417:2021Medical devices — Information to be supplied by the manufacturerStandarts spēkā
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