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Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
20.99 WD approved for registration as CD
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
Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts
60.60 Standard published
Health informatics -- Guidance on standards for enabling safety in health software
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
Health software and health IT systems safety, effectiveness and security - Part 2-1: Coordination - Guidance for the use of assurance cases for safety and security
30.60 Close of voting/ comment period
Health software - Part 2: Health and wellness apps - Quality and reliability
60.60 Standard published
IEC TR 60601-4-X: Medical electrical equipment - Part 4-X: Guidance and interpretation - essential performance fault safety
00.00 Proposal for new project received