IEC 60601-2-54:2009

Title
Abstract

IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54. The contents of the corrigenda of March 2010 and June 2011 have been included in this copy.

Issue Date

2009-06-29

Category

MED

Included in IECEE System

2009-07-27

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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

2017-01-20

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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

Baltimore, MD 21230-3432

United States of America

Gyeonggi-do

Korea, Republic of

Gimpo-si

Korea, Republic of

Milano

Italy

Boxborough,

United States of America

Tokyo

Japan

Fridley, MN

United States of America

Kista

Sweden

United Kingdom

Shanghai

China

Guangzhou, Guangdong

China

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

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

Gyeonggi-do

Korea, Republic of

Bangalore – 560 100

India

Shanghai

China

Nanshan District

China

Budapest

Hungary

Yokohama,

Japan

Nürnberg

Germany

Guangzhou

China

München

Germany

Ballerup

Denmark

Uiwang-si

Korea, Republic of

Fremont,

United States of America

Melville

United States of America

Northbrook, IL 60062

United States of America

Suzhou

China

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13607

Baltimore,

United States of America

13348

Reichenwalde b. Berlin

Germany

13351

Milano

Italy

13371

Kista

Sweden

13375

Surrey

United Kingdom

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

13343

Fontenay-Aux-Roses

France

13641

Paris Cedex 15

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13349

Budapest

Hungary

13354

Yokohama

Japan

13345

Nürnberg

Germany

13427

Singapore 609937

Singapore

13346

München

Germany

13340

Ballerup

Denmark

13423

Northbrook

United States of America

13344

Offenbach / Main

Germany

Id

Name

City

Country

20269

Modiin

Israel