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Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
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
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 (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 22367:2020)
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
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
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
90.92 Standard to be revised
Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations
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
Application of risk management for IT-networks incorporating medical devices — Part 2-8: Application guidance — Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
90.92 Standard to be revised
Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-9: Application guidance — Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
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
60.60 Standard published
Medical devices - Application of risk management to medical devices
60.60 Standard published
Medical laboratories — Application of risk management to medical laboratories
90.92 Standard to be revised
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
90.20 Standard under periodical review
Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
90.20 Standard under periodical review
Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
60.60 Standard published