Back

EVS-EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)

General information
Valid from 08.12.2006
Base Documents
IEC 60601-1:2005; EN 60601-1:2006; EN 60601-1:2006/AC:2010
Standard history
Status
Date
Type
Name
Amendment
EN 60601-1:2006/prA2:2019
Main + amendment
prEVS-EN 60601-1:2006+A1+A12+A2
07.11.2014
Amendment
14.11.2013
Amendment
02.11.2011
Amendment
08.04.2010
Corrigendum
08.12.2006
Main + corrigendum
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. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
*
*
*
PDF
47.16 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016
Main

EVS-EN ISO 14971:2019

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Newest version Valid from 02.01.2020
Main

EVS-EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
Newest version Valid from 03.01.2017
Main + amendment

EVS-EN 62304:2006+A1:2015

Medical device software - Software life-cycle processes
Newest version Valid from 15.11.2019