Implants for surgery — Essential principles of safety and performance
手术植入 - 基本原则

2018-01-03

Implants for surgery. Essential principles of safety and performance
外科植入物 安全和性能的基本原则

2018-01-10

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

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

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

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　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

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

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 electrical equipment-Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
医用电气设备

2019-09-02

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
医用电气设备第2-58部分:眼科手术用晶状体摘除和玻璃体切除装置基本安全和基本性能的特殊要求

2014-09-10

Medical electrical equipment — Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
医用电气设备第2-58部分:眼科手术用晶状体摘除装置和玻璃体切除装置的基本安全和基本性能的特殊要求

2024-03-08

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
医用电气设备.第2-58部分:眼科手术用晶状体摘除装置和玻璃体切除装置的基本安全和基本性能的特殊要求

2024-03-06

Medical electrical equipment -- Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
医用电气设备第2-58部分:眼科手术用晶状体摘除装置和玻璃体切除装置基本安全和基本性能的特殊要求

2009-07-08

BS EN 60601-2-58. Medical electrical equipment. Part 2-58. Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
英国标准EN 60601-2-58 医用电气设备 第2-58部分 眼科手术用晶状体摘除和玻璃体切除装置的基本安全和基本性能详细要求

2007-05-17

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (IEC 80601-2-58:2014 + A1:2016); German version EN 80601-2-58:2015 + A1:2019
医用电气设备.第2-58部分:眼科手术用晶状体摘除装置和玻璃体切除装置的基本安全和基本性能的特殊要求（IEC 80601-2-58-2014+A1-2016）；德文版EN 80601-2-58:2015+A1:2019

2020-06-01