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

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

Изделия медицинские. Руководство по выбору стандартов, поддерживающих важнейшие принципы обеспечения безопасности и эксплуатационных характеристик медицинских изделий
医疗设备 关于选择支持公认的医疗器械安全和性能基本原则的标准的指导意见

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

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

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

Сводный комплект технической документации для демонстрации соответствия существенным принципам обеспечения безопасности и основных функциональных характеристик медицинских изделий
总结技术文件 说明符合医疗器械安全和性能的基本原则

Сводный комплект технической документации для демонстрации соответствия общим принципам обеспечения безопасности и основных функциональных характеристик медицинских изделий для диагностики in vitro
摘要技术文件 用于证明符合体外诊断医疗器械安全和性能的基本原则