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ISO/IEC Guide 63:2019PublishedGuide to the development and inclusion of aspects of safety in International Standards for medical devicesISO/TS 4452:2025PublishedSpecification and demonstration of system reliability of single-use drug delivery systemsISO 13485:2016PublishedMedical devices — Quality management systems — Requirements for regulatory purposesISO 14971:2019PublishedMedical devices — Application of risk management to medical devicesISO 15223-1:2021PublishedMedical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirementsISO 15223-2:2010PublishedMedical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validationISO 15378:2017PublishedPrimary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)ISO/TR 19244:2014PublishedGuidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and cathetersISO 20069:2019PublishedGuidance for assessment and evaluation of changes to drug delivery systemsISO/TR 20416:2020PublishedMedical devices — Post-market surveillance for manufacturersISO 20417:2026PublishedMedical devices — Information to be supplied by the manufacturerISO/TS 24971-2:2026PublishedMedical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligenceISO/TR 24971:2020PublishedMedical devices — Guidance on the application of ISO 14971IEC 62304:2006PublishedMedical device software — Software life cycle processesIEC/TR 62366-2:2016PublishedMedical devices — Part 2: Guidance on the application of usability engineering to medical devicesIEC 62366-1:2015PublishedMedical devices — Part 1: Application of usability engineering to medical devicesIEC 80001-1:2021PublishedApplication of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health softwareIEC/TR 80001-2-5:2014PublishedApplication of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systemsISO/TR 80002-2:2017PublishedMedical device software — Part 2: Validation of software for medical device quality systemsIEC/TR 80002-3:2014PublishedMedical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)IEC/TR 80002-1:2009PublishedMedical device software — Part 1: Guidance on the application of ISO 14971 to medical device softwareIEC 80601-2-77:2019PublishedMedical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipmentIEC 80601-2-78:2019PublishedMedical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviationISO 11197Under developmentMedical supply unitsISO/DIS 15223-2Under developmentMedical devices — Symbols to be used with information to be supplied by the manufacturer — Part 2: Symbol development, selection and validation