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EVS-EN 60601-1-3:2008

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008)

General information
Valid from 09.06.2008
Base Documents
IEC 60601-1-3:2008; EN 60601-1-3:2008; EN 60601-1-3:2008/AC:2010
Directives or regulations
93/42/EEC Medical devices (MDD)
Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Standard history

Status
Date
Type
Name
01.04.2021
Amendment
01.04.2021
Main + amendment
01.11.2017
Main + amendment
06.12.2016
Amendment
05.08.2013
Amendment
08.04.2010
Corrigendum
09.06.2008
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. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of the PATIENT are used for diagnosis, planning or guidance of medical procedures.
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