IEC 60601-2-27:2011

Title
Abstract

IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. The contents of the corrigendum of May 2012 have been included in this copy.

Issue Date

2011-03-30

Category

MED

Included in IECEE System

2011-08-16

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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

2016-10-18

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Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

Shanghai

China

94447 Plattling

Germany

Seoul

Korea, Republic of

Pointe Claire

Canada

Toronto

Canada

Arnhem

Netherlands

Guangzhou

China

Campanillas

Spain

New Taipei City

Chinese Taipei

Shanghai

China

Aix en Provence

France

Irvine

United States of America

Reichenwalde b. Berlin

Germany

Binyamina

Israel

Modiin

Israel

Gimpo-si

Korea, Republic of

Milano

Italy

Boxborough,

United States of America

Kaufbeuren

Germany

Duluth,

United States of America

Lake Forest,

United States of America

Menlo Park,

United States of America

Fridley, MN

United States of America

United Kingdom

Shanghai

China

Guangzhou, Guangdong

China

Taipei City

Chinese Taipei

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Oak Creek

United States of America

Carlsbad,

United States of America

Gyeonggi-do

Korea, Republic of

Gyeonggi-do 12735

Korea, Republic of

Tampere

Finland

Helsinki

Finland

Puchheim

Germany

Madrid

Spain

Shanghai

China

Guangzhou

China

Shenzhen

China

Dongguan

China

Bangalore – 560 100

India

Tel-Aviv

Israel

Shenzhen

China

Budapest

Hungary

Yokohama,

Japan

Nürnberg

Germany

Taoyuan City 333

Chinese Taipei

Pleasanton,

United States of America

San Diego

United States of America

GORMLEY L0H 1G0

Canada

Jiangsu

China

Guangzhou

China

Tokyo

Japan

München

Germany

Bengaluru

India

Whitefield

India

Ballerup

Denmark

Warszawa

Poland

Mie 516-0021

Japan

Uiwang-si

Korea, Republic of

Melville

United States of America

Mounds View

United States of America

Northbrook, IL 60062

United States of America

Research Triangle Park

United States of America

Guangzhou

China

Kyiv

Ukraine

Taipei City

Chinese Taipei

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

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

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13359

Gyeonggi-do

Korea, Republic of

13356

Gyeongsangnam-do

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

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

13374

Kyiv

Ukraine

13344

Offenbach / Main

Germany