医疗器械　保障医疗器械安全和性能公认基本原则的标准选用指南
Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

2016-01-26

Medical devices- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
医疗器械.支持医疗器械安全和性能公认基本原则的标准选择指南

2005-10-19

医疗器械灭菌确认　选择微生物挑战和染菌部位的指南
Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sites

2016-01-26

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
医疗器械灭菌验证的微生物挑战和接种地点选择指南

2009-09-03

Medical devices. Recognized essential principles of safety and performance of medical devices-General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
医疗设备 公认的医疗器械安全和性能基本原则

2017-09-20

Medical devices. Recognized essential principles of safety and performance of medical devices-General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
医疗设备 医疗器械安全和性能的公认基本原则第1部分:所有非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

2016-03-31

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

의료기기 — 의료기기의 안전 및 성능에 대한 승인된 필수원칙 — 제1부: 모든 비IVD 의료기기의 일반적인 필수원칙과 추가된 특정 필수원칙 및 표준 선택 지침
医疗器械 - 医疗器械的安全和性能认可的基本原则 - 第1部分:所有非IVD医疗器械的一般基本原则和其他具体基本原则以及对标准选择的指导

2019-11-25

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-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1部分:所有非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

2016-08-10

Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
选择测试以评估医疗器械潜在神经毒性的标准指南

2019-03-01

医疗器械行业标准的制定 第2部分:工作指南
Development of medical devices industrial standards—Part 2:Guidance for work

2005-07-18

Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
选择测试土壤以确认可重复使用医疗设备清洁方法的标准指南

2020-07-15

医疗器械神经毒性评价　第1部分：评价潜在神经毒性的试验选择指南
Evaluation of neurotoxicity of medical devices—Part 1:Standard guide for selecting tests to evaluate potential neurotoxicity

2019-07-24

Application of risk management for IT-networks incorporating medical devices-Application guidance. Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
风险管理在医疗设备IT网络中的应用

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
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