EVS-EN 60601-1-3:2008+A1:2013

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+IEC 60601-1-3:2008/A1:2013)

General information
Valid from 08.06.2015
Base Documents
IEC 60601-1-3:2008; EN 60601-1-3:2008; EN 60601-1-3:2008/AC:2010; IEC 60601-1-3:2008/A1:2013; EN 60601-1-3:2008/A1:2013; EN 60601-1-3:2008/A1:2013/AC:2014
Directives or regulations
93/42/EEC Medical devices (MDD)
Standard history
EN IEC 60601-1-3:2008/prA2:2020
Main + amendment
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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Standard monitoring
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