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Health software - Part 1: General requirements for product safety
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 2-3: 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 2-9: 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 3: Process reference model of medical device software life cycle processes (IEC 62304)
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
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
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
