IEC 60601-2-28:2017

Title
Abstract

IEC 60601-2-28:2017 is also available as IEC 60601-2-28:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. 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. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included.

Issue Date

2017-06-16

Category

MED

Included in IECEE System

2017-08-14

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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

2022-09-14

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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

Yongin-si

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

Shanghai

China

Guangzhou, Guangdong

China

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Gyeonggi-do

Korea, Republic of

Gyeonggi-do 12735

Korea, Republic of

Tampere

Finland

Helsinki

Finland

Munich

Germany

Gunpo-si

Korea, Republic of

Madrid

Spain

Shanghai

China

Guangzhou

China

Gyeonggi-do

Korea, Republic of

Shanghai

China

Nanshan District

China

Budapest

Hungary

Yokohama,

Japan

Nürnberg

Germany

Boxborough, MA 01719

United States of America

Pleasanton,

United States of America

München

Germany

Ballerup

Denmark

Mie 516-0021

Japan

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

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

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13349

Budapest

Hungary

13354

Yokohama

Japan

13345

Nürnberg

Germany

13346

München

Germany

13340

Ballerup

Denmark

13423

Northbrook

United States of America

13344

Offenbach / Main

Germany

Id

Name

City

Country

13348

Reichenwalde b. Berlin

Germany