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EVS-EN IEC 60601-2-54:2024

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2022)

General information

Valid from 01.10.2024
Base Documents
IEC 60601-2-54:2022; EN IEC 60601-2-54:2024
ICS Groups
11.040.50 Radiographic equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.10.2024
Main
EVS-EN IEC 60601-2-54:2024
16.09.2019
Corrigendum
EVS-EN 60601-2-54:2009+A1+A2:2019/AC:2019
15.08.2019
Main + amendment
EVS-EN 60601-2-54:2009+A1+A2:2019
15.08.2019
Amendment
EVS-EN 60601-2-54:2009/A2:2019
03.12.2015
Main + amendment
EVS-EN 60601-2-54:2009+A1:2015
03.12.2015
Amendment
EVS-EN 60601-2-54:2009/A1:2015
06.11.2009
Main
EVS-EN 60601-2-54:2009

IEC 60601-2-54 applies to the basic safety and essential performance of ME equipment and ME systems intended for projection radiography and indirect radioscopy. ME equipment and ME systems designed to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of IEC 60601-2-54. The scope of this standard also excludes radiotherapy simulators. If a clause or subclause is specifically intended to apply to ME equipment and ME systems only, the title and content of that clause or subclause will say so.

IEC 60601-2-54:2022 text has been approved in Europe as EN IEC 60601-2-54:2024 without any changes.

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Standard monitoring
English (PDF 674 KB) Estonian (PDF 1 MB)

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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