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Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations

60.60 Standard published

ISO/TC 215 more

Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems

60.60 Standard published

ISO/TC 215 more

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

ISO/TC 215 more

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

ISO/TC 215 more

Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software

60.60 Standard published

ISO/TC 210 more

Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

60.60 Standard published

ISO/TC 210 more

Medical devices - Application of risk management to medical devices

60.60 Standard published

TC 62/SC 62A more

Medical devices - Guidance on the application of ISO 14971

60.60 Standard published

TC 62/SC 62A more

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

60.60 Standard published

TC 62/SC 62A more

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

TC 62/SC 62A more

Medical device software - Part 2: Validation of software for medical device quality systems

60.60 Standard published

TC 62/SC 62A more

Medical devices – Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence

20.99 WD approved for registration as CD

TC 62/SC 62A more

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

60.60 Standard published

ISO/TMBG more