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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
Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
60.60 Standard published
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
60.60 Standard published
Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
60.60 Standard published
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
60.60 Standard published
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
60.60 Standard published
Health software and health IT systems safety, effectiveness and security - Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls
30.60 Close of voting/ comment period
Medical devices - Application of risk management to medical devices
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971
60.60 Standard published
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
60.60 Standard published
Medical device software - Part 2: Validation of software for medical device quality systems
60.60 Standard published
Medical devices – Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence
20.99 WD approved for registration as CD
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
60.60 Standard published