现行

GOST R 56701-2015

Лекарственные средства для медицинского применения. Руководство по планированию доклинических исследований безопасности с целью последующего проведения клинических исследований и регистрации лекарственных средств
医疗用药品关于进行人体临床试验和药品销售授权的非临床安全性研究指南

现行

CNAS CC42-2006

《职业健康安全管理体系认证机构通用要求》应用指南

2006-06-01

现行

UNE-EN 60601-1-8-2005

Medical electrical equipment -- Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
医用电气设备第1-8部分:安全通用要求附属标准:医用电气设备和医用电气系统报警系统的通用要求、试验和指南

2005-04-20

现行

BS EN 60601-1-8-2007+A2-2021

Medical electrical equipment-General requirements for basic safety and essential performance. Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
医用电气设备

2021-08-20

现行

AS IEC 60601.1.8-2017

Medical electrical equipment, Part 1.8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
医用电气设备 第1.8部分:基本安全和基本性能的一般要求-附带标准:医用电气设备和医用电气系统中报警系统的一般要求、试验和指南

2017-06-08

现行

YY 9706.108-2021

医用电气设备　第1-8部分：基本安全和基本性能的通用要求　并列标准：通用要求,医用电气设备和医用电气系统中报警系统的测试和指南
Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

2021-03-09

现行

KS C IEC 60601-1-8

의료용 전기기기 — 제1-8부: 기본안전 및 필수성능에 관한 일반 요구사항 —보조표준: 의료용 전기기기 및 의료용 전기시스템의 경보 장치에 관한 일반 요구사항, 시험 및 지침
医用电气设备第1-8部分:基本安全和基本性能的一般要求附带标准:医用电气设备和医用电气系统报警系统的一般要求、试验和指南

2021-12-28

现行

KS C IEC 60601-1-8

의료용 전기기기 — 제1-8부: 기본안전 및 필수성능에 관한 일반 요구사항 —보조표준: 의료용 전기기기 및 의료용 전기시스템의 경보 장치에 관한 일반 요구사항, 시험 및 지침
医用电气设备第1-8部分:基本安全和基本性能的一般要求附带标准:医用电气设备和医用电气系统报警系统的一般要求、试验和指南

2021-12-28

现行

UNE-EN 60601-1-8-2008

Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
医用电气设备第1-8部分:基本安全和基本性能的一般要求附带标准:医用电气设备和医用电气系统报警系统的一般要求、试验和指南

2008-09-10

现行

IEC 60601-1-8-2006+AMD1-2012 CSV

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
医用电气设备第1-8部分:一般要求 基本安全和基本性能-附带标准: 工业用报警系统的一般要求、试验和指南 医用电气设备和医用电气系统

2012-11-28

现行

IEC 60601-1-8-2006

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
医疗电气设备 - 第1-8部分:基本安全和基本性能的一般要求 - 抵押标准:医疗电气设备和医疗电气系统中的报警系统的一般要求 测试和指导

2006-10-25

现行

IEC 60601-1-8-2006+AMD1-2012+AMD2-2020 CSV

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
医用电气设备.第1-8部分:基本安全和基本性能的一般要求.并列标准:医用电气设备和医用电气系统中报警系统的一般要求、试验和指南

2020-07-23

现行

IEC 60601-1-8-2006

Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
医用电气设备第1-8部分:基本安全和基本性能的一般要求；附带标准:医疗电气设备和医疗电气系统中报警系统的一般要求、试验和指南

2006-11-13

现行

IEC 60601-1-8-2006/AMD2-2020

Amendment 2 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
修改件2.医用电气设备.第1-8部分:基本安全和基本性能的一般要求.附带标准:医用电气设备和医用电气系统报警系统的一般要求 试验和指南

2020-07-23

现行

IEC 60601-1-8-2006/AMD1-2012

Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
修改件1.医用电气设备.第1-8部分:基本安全和基本性能的一般要求.附带标准:医用电气设备和医用电气系统报警系统的一般要求 试验和指南

2012-11-28

现行

IEC 60601-1-8-2006/Amd 2-2020

Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems — Amendment 2
医用电气设备第1-8部分:基本安全和基本性能的一般要求附带标准:医用电气设备和医用电气系统报警系统的一般要求、试验和指南修改2

2020-09-23

现行

IEC 60601-1-8-2006/Amd 1-2012

Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems — Amendment 1
医用电气设备第1-8部分:基本安全和基本性能的一般要求附带标准:医用电气设备和医用电气系统报警系统的一般要求、试验和指南修改1

2012-12-03

现行

KS C IEC 60601-1-8

의료용 전기 기기－제1－8부：안전에 관한 일반 요구 사항－보조 규격：의료용 전기 기기 및의료용 전기 시스템의 경보 장치에 관한일반 요구 사항, 시험 및 지침
医用电气设备第1－8部分:安全通用要求附带标准:医用电气设备和医用电气系统报警系统的通用要求、试验和导则

2017-12-29

现行

BS PD IEC/TR 60601-4-3-2018

Medical electrical equipment-Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
医用电气设备

2019-01-04

现行

UNE-CEN/TR 14715-2005

Safety of machinery - Ionizing radiation emited by machinery - Guidance for the application of technical standards in the design of machinery in order to comply with legislative requirements
机械安全.机械发出的电离辐射.符合立法要求的机械设计中技术标准应用指南

2005-03-16