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ICS:11.040.01
Showing 19–27 of 31 results
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ISO 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices
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ISO 80001:2012 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
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ISO 80001:2014 Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance for distributed alarm systems
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ISO 80001:2016 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
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ISO 80001:2017 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
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ISO 80001:2021 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
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ISO 80002:2009 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software
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ISO 80002:2014 Medical device software – Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
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ISO 80002:2017 Medical device software – Part 2: Validation of software for medical device quality systems
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