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【国际标准】 Medical device software - Part 2: Validation of software for medical device quality systems
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标准简介适用范围：
暂无
标准号：
ISO TR 80002-2:2017 EN
标准名称：
Medical device software - Part 2: Validation of software for medical device quality systems
英文名称：
Medical device software - Part 2: Validation of software for medical device quality systems标准状态：
现行-
发布日期：
2017-06-13 -
实施日期：
出版语种：
EN
- 其它标准
- 上一篇： ISO TR 80001-2-7:2015 EN 8b8393bf 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
- 下一篇： ISO TR 9007:1987 EN 1e62d39c Information processing systems - Concepts and terminology for the conceptual schema and the information base
- 推荐标准
- IEC 80001-1:2021 EN-FR 1f87aa52 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
- IEC 80001-1:2021 EN/FR daa96a77 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
- IEC TR 80001-2-5:2014 EN 8f479dad Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
- IEC TR 80001-2-9:2017 EN f00b804b 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
- IEC/TR 80001-2-2:2012 EN 34ec3f43 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
- IEC/TR 80001-2-3:2012 EN a70703fb Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
- IEC/TR 80001-2-4:2012 EN 07cad53a Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations
- IEC/TR 80001-2-5:2014 EN 53a3c261 Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
- IEC/TR 80001-2-9:2017 EN 6948e584 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
- IEC/TR 80002-3:2014 EN 7cc1472a Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
- ISO TR 80001-2-6:2014 EN 30f74894 Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
- ISO/TR 80002-2:2017 EN 37170573 Medical device software — Part 2: Validation of software for medical device quality systems
- IEC/TR 80001-2-1:2012 EN 32ae1d02 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
- IEC/TR 80001-2-8:2016 EN 9929856b 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
- IEC/TR 80002-1:2009 EN 9daea368 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
