IEC 60601-2-47:2012

Title
Abstract

IEC 60601-2-47:2012 concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements the general standard IEC 60601-1 (third edition 2005). The requirements of this particular standard take priority over those of the general standard. Within the scope of this standard are systems of the following types:
a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results.
b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.
The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories. If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard. This standard does not apply to systems that do not continuously record and analyse the ECG (for example, 'intermittent event recorders'). This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC 60601-1.

Issue Date

2012-02-16

Category

MED

Included in IECEE System

2012-07-09

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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

2022-09-30

Download70 kb

CanadaCanada

2017-11-22

Download165 kb

Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

Littleton 01460

United States of America

94342 Strasskirchen

Germany

Toronto

Canada

Guangzhou

China

Calenzano (FI)

Italy

182 00 Praha 8 – Troja

Czech Republic

New Taipei City

Chinese Taipei

Shanghai

China

Reichenwalde b. Berlin

Germany

Modiin

Israel

Gimpo-si

Korea, Republic of

Milano

Italy

Boxborough,

United States of America

Duluth,

United States of America

Campoformido (UD)

Italy

Lake Forest,

United States of America

Menlo Park,

United States of America

Fridley, MN

United States of America

Plano,

United States of America

United Kingdom

Taipei City

Chinese Taipei

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Oak Creek

United States of America

Carlsbad,

United States of America

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Toronto

Canada

Tampere

Finland

Puchheim

Germany

Taiwan 248

Chinese Taipei

Shanghai

China

Guangzhou

China

Shenzhen

China

Dongguan

China

Bangalore – 560 100

India

Nanshan District

China

Budapest

Hungary

Yokohama,

Japan

Taoyuan City 333

Chinese Taipei

Peabody

United States of America

San Diego

United States of America

GORMLEY

Canada

Jiangsu

China

Guangzhou 510656

China

Tokyo 160-0023

Japan

München

Germany

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

Huangpu District, Guangzhou

China

Taipei City

Chinese Taipei

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13339

Praha 8 - Troja 171 02

Czech Republic

13607

Baltimore,

United States of America

13348

Reichenwalde b. Berlin

Germany

20269

Modiin

Israel

13351

Milano

Italy

13371

Kista

Sweden

13375

Surrey

United Kingdom

13365

Singapore

Singapore

13424

IL 60005

United States of America

13359

Gyeonggi-do

Korea, Republic of

13356

Seoul

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13469

Toronto,

Canada

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

13597

Tel-Aviv

Israel