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EVS-EN 60601-1-3:2008+A1+A11:2016

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

General information

Valid from 01.11.2017
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; EN 60601-1-3:2008/A11:2016
ICS Groups
11.040.50 Radiographic equipment 13.280 Radiation protection
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.04.2021
Amendment
EVS-EN 60601-1-3:2008/A2:2021
01.11.2017
Main + amendment
EVS-EN 60601-1-3:2008+A1+A11:2016
06.12.2016
Amendment
EVS-EN 60601-1-3:2008/A11:2016
05.06.2014
Corrigendum
EVS-EN 60601-1-3:2008/A1:2013/AC:2014
05.08.2013
Amendment
EVS-EN 60601-1-3:2008/A1:2013
08.04.2010
Corrigendum
EVS-EN 60601-1-3:2008/AC:2010
09.06.2008
Main + corrigendum
EVS-EN 60601-1-3:2008
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 a human PATIENT are used for diagnosis, planning or guidance
of medical procedures.

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English (PDF 461 KB) Estonian (PDF 320 KB)

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Amendment

EVS-EN 60601-1-3:2008/A2:2021

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/A2:2021)
Valid from 01.04.2021
Main

EVS-EN 60601-2-25:2015

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
Newest version Valid from 04.11.2015
Main

EVS-EN 60601-2-27:2014

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Newest version Valid from 03.09.2014
Main

EVS-EN 60601-2-18:2015

Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Newest version Valid from 04.11.2015

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Main

EVS-EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Valid from 03.12.2015
Main + amendment

EVS-EN 60601-2-43:2010+A1+A2:2020

Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010 + IEC 60601-2-43:2010/A1:2017 + IEC 60601-2-43:2010/A2:2019)
Withdrawn from 03.04.2023
Amendment

EVS-EN 60601-1-6:2010/A1:2015

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Valid from 08.06.2015
Amendment

EVS-EN 60601-1-8:2007/A11:2017

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
Valid from 04.04.2017

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English