AAMI/IEC TIR62354:2015-医用电气设备通用试验规程-国家数字标准馆

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General testing procedures for medical electrical equipment 医用电气设备通用试验规程

发布日期： 2015-04-12

本技术报告适用于医用电气设备。本技术报告的目的是
根据IEC 60601-1:1988（包括
IEC 60601-1-1:2000）和IEC 60601-1:2005以及IEC 60601-1:2005的附带规定，以及
IEC 60601-1:2005/AMD1:2012。

This technical report applies to medical electrical equipment. The object of this technical report is
to provide guidance on general testing procedures according to IEC 60601-1:1988 (including the
collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012.

分类信息

发布单位或类别：美国-美国医疗器械促进协会

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研制信息

相似标准/计划/法规

IEC TR 62354-2014

General testing procedures for medical electrical equipment
医用电气设备通用试验规程

BS PD IEC/TR 62354-2014

General testing procedures for medical electrical equipment
医用电气设备通用试验规程

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
医疗电气设备 - 医疗电气设备维修后的经常性试验和试验

BS EN 62353-2014

Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
医用电气设备医用电气设备的反复试验和修理后试验

UNE-EN 62353-2009

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
医用电气设备.医用电气设备的重复试验和修理后试验

GOST R IEC 62353-2013

Изделия медицинские электрические. Периодические испытания и испытания после ремонта изделий медицинских электрических
医疗电气设备医疗电气设备修复后的经常性试验和试验

医用电气设备　医用电气设备周期性测试和修理后测试
Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment

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

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

UNE-EN 60601-1-1993

MEDICAL ELECTRICAL EQUIPMENT. GENERAL REQUIEREMENTS FOR SAFETY.
医用电气设备安全的一般要求

医用电气设备　可靠性通用要求
Medical electrical equipment—General requirements for reliability

BS 05/30107843 DC

IEC 62353. Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
IEC 62353 医用电气设备医用电气设备的反复试验和修理后试验

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

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

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

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

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

JIS T 1002-1992

General rules of testing methods for safety of medical electrical equipment (FOREIGN STANDARD)
医用电气设备安全性试验方法通则（国外标准）

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

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

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