IEC 60601-1-12:2014

Title
Abstract

IEC 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.

Issue Date

2014-06-19

Category

MED

Included in IECEE System

2014-12-01

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Testing Equipment List

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.

No information declared

Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

Littleton 01460

United States of America

Wismar

Germany

Pointe Claire

Canada

Guangzhou

China

Dresden

Germany

Stuttgart

Germany

Calenzano (FI)

Italy

Hull

United Kingdom

New Taipei City

Chinese Taipei

Shanghai

China

Austin

United States of America

Union City

United States of America

Reichenwalde b. Berlin

Germany

Hørsholm 2970

Denmark

Modiin

Israel

Gimpo-si

Korea, Republic of

Boxborough,

United States of America

Lake Forest,

United States of America

Kista

Sweden

United Kingdom

Guangzhou, Guangdong

China

Taipei City

Chinese Taipei

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Oak Creek

United States of America

Carlsbad,

United States of America

Lysaker

Norway

Puchheim

Germany

Gunpo-si

Korea, Republic of

Suwanee

United States of America

Taiwan 248

Chinese Taipei

Madrid

Spain

Shanghai

China

Guangzhou

China

Ljubljana

Slovenia

Bangalore – 560 100

India

Tel-Aviv

Israel

Shenzhen

China

Budapest

Hungary

Yokohama,

Japan

Taoyuan City 333

Chinese Taipei

New Brighton

United States of America

San Diego

United States of America

Jiangsu

China

Guangzhou

China

München

Germany

Ballerup

Denmark

Warszawa

Poland

Uiwang-si

Korea, Republic of

Mounds View

United States of America

Northbrook, IL 60062

United States of America

Suzhou

China

Taipei City

Chinese Taipei

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13478

Skelmersdale

United Kingdom

13607

Baltimore,

United States of America

13348

Reichenwalde b. Berlin

Germany

21077

Broendby

Denmark

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

Gyeongsangnam-do

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

13367

Ljubljana

Slovenia

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

26080

Beaucouzé

France

13372

Fehraltorf

Switzerland

13641

Paris Cedex 15

France

13469

Toronto,

Canada