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

基本信息

标准号

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

标准状态

现行

发布单位或类别

英国-英国标准学会(GB-BSI);

发布日期

实施日期

废止日期

CCS分类

ICS分类

研制信息

起草单位

- 展开▼

起草人

归口单位

摘要

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS inME EQUIPMENT and ME SYSTEMS.It also provides guidance for the application of ALARM SYSTEMS.Cross References:IEC 60601-1:2005/AMD1:2012EN ISO 3744 (ISO 3744:2010) ASEN 60601-1 (IEC 60601-1:2005) ASIEC 61672-1:2002IEC 60417:2007 Ed 1IEC 62366-1:2015EN 61672-1 (IEC 61672-1:2002) ASISO 7000:2012 DB ED4EN 60601-1 Amd 1 (10/13) IEC ASIEC 60601-1:2005ISO 3744:2010 Ed 3EN 62366-1 (IEC 62366-1:2015) AS AAMI EC57-293ANSI/AAMI HE48:199393/42/EECISO 11429:1996ISO 14971:2000 Ed 1ISO 9703-2:1994IEC 60513:1994ISO 11428:1996 本国际标准适用于医用电气设备和医用电气系统（以下简称医用电气设备和医用电气系统）的基本安全和基本性能。本附属标准规定了医用电气设备和医用电气系统中报警系统和报警信号的要求。它还为报警系统的应用提供了指导。交叉引用:IEC 60601-1:2005/AMD1:2012EN ISO 3744（ISO 3744:2010）ASEN 60601-1（IEC 60601-1:2005）ASIEC 61672-1:2002IEC 60417:2007 Ed 1IEC 62366-1:2015EN 61672-1（IEC 61672-1:2002）ASISO 7000:2012 DB ED4EN 60601-1 Amd 1（10/13）IEC ASIEC 60601-1:2005 ISO 3744:2010 Ed 3EN 62366-1（IEC 62366-1:2015）作为AAMI EC57-293ANSI/AAMI HE48:199393/42/EECISO 11429:1996ISO 14971:2000 Ed 1ISO 9703-2:1994IEC 60513:1994ISO 11428:1996 展开▼

关联标准

代替如下标准

1.BS EN 60601-1-8:2007+A11:2017(July 2017) 。

2.BS EN 60601-1-8:2007+A1:2013(July 2014) 。

3.BS EN 60601-1-8:2007(November 2007) 。

4.BS EN 60601-1-8:2004(February 2007) 。

5.BS EN 475:1995(July 1995) 。

6.BS 7618-1:1992(December 1992) 。

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