IEC 60601-2-54:2022

Title
Abstract

IEC 60601-2-54:2022 is available as IEC 60601-2-54:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-54:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this document. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators. 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. IEC 60601-2-54:2022 edition cancels and replaces the first edition published in 2009, Amendment 1:2015 and Amendment 2:2018. This edition constitutes a technical revision. This edition includes editorial and technical changes to reflect the IEC 60601 1:2005/AMD2:2020. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER;
b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically applicable in this document have been moved to 201.3;
c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares;
d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube assemblies” has been removed from this document as its requirements are sufficiently and clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017;
e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS.

Issue Date

2022-09-26

Category

MED

Included in IECEE System

2022-12-16

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No information declared

DISCLAIMER: National differences

The National differences and Group differences, National Deviations and Special National conditions (SNC), are based solely on information provided to the Secretariat by the IECEE Member Bodies and/or NCBs and other sources. The IEC/IECEE is not responsible for, nor will it take any position related to, the accuracy or validity of the information provided. To verify the current status of this type of information, we recommend contacting the Member Body (MB) or National Certification Body (NCB) of the relevant country.

Group Differences are applicable for CENELEC member countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Group/Country

Reference

Last Modified

Differences

TRF Addendum

CanadaCanada

2023-06-20

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Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

Shanghai

China

Seoul

Korea, Republic of

Pointe Claire

Canada

Toronto

Canada

Arnhem

Netherlands

Yongin-si

Korea, Republic of

Gyeonggi-do

Korea, Republic of

Gyeonggi-Do

Korea, Republic of

Milano

Italy

Boxborough,

United States of America

Fridley, MN

United States of America

Shanghai

China

Guangzhou, Guangdong

China

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

TRAPPES

France

Gyeonggi-do

Korea, Republic of

Gyeonggi-do 12735

Korea, Republic of

Puchheim

Germany

Gunpo-si

Korea, Republic of

Madrid

Spain

Shanghai

China

Guangzhou

China

Wuhan

China

Gyeonggi-do

Korea, Republic of

Budapest

Hungary

München

Germany

Ballerup

Denmark

Uiwang-si

Korea, Republic of

Northbrook, IL 60062

United States of America

Suzhou

China

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13348

Reichenwalde b. Berlin

Germany

13351

Milano

Italy

13371

Kista

Sweden

13365

Singapore

Singapore

13424

IL 60005

United States of America

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13359

Gyeonggi-do

Korea, Republic of

13356

Seoul

Korea, Republic of

13641

Paris Cedex 15

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13349

Budapest

Hungary

13346

München

Germany

13340

Ballerup

Denmark

13423

Northbrook

United States of America

13344

Offenbach / Main

Germany

Id

Name

City

Country

13607

Baltimore,

United States of America

20269

Modiin

Israel

13345

Nürnberg

Germany

13427

Singapore 609937

Singapore