Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
医疗器械软件第1部分:ISO 14971在医疗器械软件中的应用指南

2009-09-25

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
医疗器械软件.第1部分:ISO 14971在医疗器械软件中的应用指南

2009-09-23

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
医疗器械软件.第1部分:ISO 14971在医疗器械软件中的应用指南

2009-09-03

Программное обеспечение медицинских изделий. Часть 1. Руководство по применению ИСО 14971 к программному обеспечению медицинских изделий
医疗器械软件 第1部分ISO 14971医疗器械软件应用指南

Medical device software-Guidance on the application of ISO 14971 to medical device software
医疗器械软件

2009-09-23

Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
最终灭菌医疗器械的包装 ISO 11607-1和ISO 11607-2应用指南

2021-11-26

Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
最终灭菌医疗器械的包装.ISO 11607-1和ISO 11607-2的应用指南

2021-11-05

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
最终灭菌医疗器械的包装ISO 11607-1和ISO 11607-2的应用指南（ISO/TS 16775-2021）；德国版CEN ISO/TS 16775:2021

2022-04-01

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
包含医疗设备的IT网络的风险管理应用.第1部分:连接医疗设备或连接健康软件的实施和使用中的安全性、有效性和安全性

2021-09-21

의료기기 가 통합된 IT 네트워크에 대한 위 험 관리의 적용 ─ 제제1부부: 연결된 의료기 기 또는 연결된 헬스 소프트웨어의 구현 및 사용 시 안전안전, 유효성 및 보안
包含医疗设备的IT网络的风险管理应用.第1部分:连接医疗设备或连接健康软件实施和使用的安全性、有效性和安全性

2022-12-28

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
联网医疗设备或联网健康软件实施和使用的安全性、有效性和安全性.第1部分:风险管理的应用

2021-09-22

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
利用动物组织及其衍生物的医疗器械第1部分:风险管理的应用

2008-06-25

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
包含医疗设备的IT网络风险管理的应用应用指南第2-7部分:医疗服务机构（HDO）如何自我评估其符合IEC 80001-1的指南

2015-03-17

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
风险管理应用于包含医疗器械的网络 - 应用指南 - 第2-7部分:医疗保健服务组织指导（Hdos）如何自我评估与Iec 80001-1

2015-03-17