医疗器械行业标准的制定 第1部分:阶段划分、代码和程序
Development of medical devices industrial standards—Part 1:Stage division,code and procedure

2005-07-18

의료기기 — 의료기기의 안전 및 성능에 대한 필수 원칙 — 제2부: IVD 의료기기에 대한 일반 필수 원칙과 부가적인 특별 원칙 및 표준 선택에 대한 지침
医疗器械 - 医疗器械的安全和性能认可的基本原则 - 第2部分:所有IVD医疗器械的一般基本原则和其他具体基本原则以及标准选择指南

2020-12-30

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
医疗器械.医疗器械安全和性能的公认基本原则.第2部分:所有IVD医疗器械的一般基本原则和附加特定基本原则及标准选择指南

2017-07-31

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
风险管理应用于包含医疗设备的网络 - 第2-8部分:应用指南 - 建立Iec 80001-2-2中确定的安全功能标准的指导

2016-05-19

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
包含医疗设备的IT网络风险管理的应用第2-8部分:IEC 80001-2-2中确定的安全能力建立标准的应用指南

2016-11-18

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 TR 80001-2-2
包含医疗设备的IT网络的风险管理应用第2-8部分:应用指南IEC TR 80001-2-2中确定的安全能力建立标准指南

2016-05-19