IEC 60601-2-47:2001

Title
Abstract

Specifies the particular safety requirements for ambulatory electrocardiographic systems. 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. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; 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.

Issue Date

2001-07-10

Category

MED

Included in IECEE System

2015-03-24

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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.

No information declared

Laboratory Name

City

Country

Responsible National Certification Body

Littleton 01460

United States of America

Toronto

Canada

182 00 Praha 8 – Troja

Czech Republic

Milano

Italy

Boxborough,

United States of America

Duluth,

United States of America

Lake Forest,

United States of America

Menlo Park,

United States of America

Fridley, MN

United States of America

Plano,

United States of America

Taipei City

Chinese Taipei

Oak Creek

United States of America

Carlsbad,

United States of America

Lysaker

Norway

Budapest

Hungary

Yokohama,

Japan

Taoyuan City 333

Chinese Taipei

Peabody

United States of America

San Diego

United States of America

Tokyo 160-0023

Japan

München

Germany

Mie 516-0021

Japan

Melville

United States of America

Mounds View

United States of America

Northbrook, IL 60062

United States of America

Taipei City

Chinese Taipei

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13339

Troja, 182 00 Praha 8

Czech Republic

13351

Milano

Italy

13371

Kista

Sweden

13365

Singapore

Singapore

13424

IL 60005

United States of America

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

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

No information declared