Application 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 software
90.93 Standard confirmed
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2026)
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
60.60 Standard published
Application 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 software
90.92 Standard to be revised
Application 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 software
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
60.60 Standard published
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
60.60 Standard published
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
60.60 Standard published
Medical products containing viable human cells — Application of risk management and requirements for processing practices
90.93 Standard confirmed
Medical devices — Application of risk management to medical devices
90.93 Standard confirmed
Medical devices - Application of risk management to medical devices
60.60 Standard published
Medical laboratories — Application of risk management to medical laboratories
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
90.92 Standard to be revised
