IEC 60601-1-2:2007

Title
Abstract

This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005. The contents of the interpretation sheet of March 2010 have been included in this copy.

Issue Date

2007-03-30

Category

EMC

Included in IECEE System

2007-11-30

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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

CENELECCENELEC

2009-02-23

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Laboratory Name

City

Country

Responsible National Certification Body

Littleton 01460

United States of America

Wismar

Germany

94342 Strasskirchen

Germany

Toronto

Canada

Matsusaka-shi

Japan

Arnhem

Netherlands

Suzhou

China

Yongin-si

Korea, Republic of

Regensdorf

Switzerland

Chassieu

France

Montigny le Bretonneux

France

Vendargues

France

182 00 Praha 8 – Troja

Czech Republic

Brooklyn Park,

United States of America

Hull

United Kingdom

Irvine

United States of America

Straubing

Germany

Fehraltorf

Switzerland

9400 Rorschach

Switzerland

Rossens

Switzerland

Zürich 8047

Switzerland

Shenzhen

China

Gyeonggi-do

Korea, Republic of

Reichenwalde b. Berlin

Germany

Aarhus N 8200

Denmark

Hørsholm 2970

Denmark

Icheon-Si,

Korea, Republic of

Binyamina

Israel

Modiin

Israel

Milano

Italy

Boxborough,

United States of America

Kaufbeuren

Germany

Duluth,

United States of America

Campoformido (UD)

Italy

Ibaraki

Japan

Lake Forest,

United States of America

Lexington KY

United States of America

Menlo Park,

United States of America

Fridley, MN

United States of America

Plano,

United States of America

Kista

Sweden

United Kingdom

Kowloon

Hong Kong

Kentwood

United States of America

Shanghai

China

Guangzhou, Guangdong

China

LongHua District, ShenZhen

China

Osaka

Japan

Tokyo

Japan

Gyeonggi-do, 15809

Korea, Republic of

Padova

Italy

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Moirans

France

TRAPPES

France

Getafe - Madrid

Spain

Ottawa

Canada

Biassono (MB)

Italy

Carlsbad,

United States of America

Pfinztal

Germany

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Gyeonggi-do 12735

Korea, Republic of

Helsinki

Finland

Puchheim

Germany

Gunpo-si

Korea, Republic of

Suwanee

United States of America

Shanghai

China

Guangzhou

China

Ljubljana

Slovenia

Gyeonggi-do,

Korea, Republic of

Hartmannsdorf

Germany

Shenzhen, Guangdong

China

Bearley, Stratford-upon-Avon, Warwickshire

United Kingdom

Taoyuan City

Chinese Taipei

Tel-Aviv

Israel

Vienna

Austria

Volpiano (TO)

Italy

Guangzhou

China

Shanghai

China

Budapest

Hungary

Yokohama,

Japan

Nürnberg

Germany

Pleasanton,

United States of America

Tampa,

United States of America

GORMLEY

Canada

Jiangsu

China

Guangzhou 510656

China

Singapore 609937

Singapore

Straubing

Germany

20061 Carugate (MI)

Italy

Ise-shi

Japan

Fremont,

United States of America

Northbrook, IL 60062

United States of America

Research Triangle Park

United States of America

Kyiv

Ukraine

Offenbach / Main

Germany

Id

Name

City

Country

13370

Madrid

Spain

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13339

Praha 8 - Troja 171 02

Czech Republic

13478

Skelmersdale

United Kingdom

13372

Fehraltorf

Switzerland

13348

Reichenwalde b. Berlin

Germany

21077

Broendby

Denmark

21201

Binyamina

Israel

20269

Modiin

Israel

13351

Milano

Italy

13371

Kista

Sweden

13375

Surrey

United Kingdom

13365

Singapore

Singapore

13424

IL 60005

United States of America

13353

Tokyo

Japan

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13749

NL - 7327 AC Apeldoorn

Netherlands

13359

Gyeonggi-do

Korea, Republic of

13356

Seoul

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13641

Paris Cedex 15

France

13361

Lysaker

Norway

13332

Vienna

Austria

13469

Toronto,

Canada

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

13367

Ljubljana

Slovenia

13347

Hartmannsdorf

Germany

13617

Essen

Germany

13349

Budapest

Hungary

13354

Yokohama

Japan

13345

Nürnberg

Germany

13427

Singapore 609937

Singapore

13346

München

Germany

13340

Ballerup

Denmark

13355

Tokyo

Japan

13423

Northbrook

United States of America

13374

Kyiv

Ukraine

13344

Offenbach / Main

Germany

Id

Name

City

Country

19449

Valsamoggia

Italy