IEC 60601-1-6:2004

Title
Abstract

Medical practice is increasingly using medical electrical equipment for observation and treatment of patients. use errors caused by inadequate medical electrical equipment usability have become an increasing cause for concern. The usability engineering process is intended to achieve reasonable usability, which in turn is intended to minimise use errors and to minimise use associated risks. Some, but not all, forms of incorrect use are amenable to control by the manufacturer. The usability engineering process is part of the process of risk control. This Collateral Standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide medical electrical equipment safety. It addresses normal use and use errors but excludes abnormal use.

Issue Date

2004-06-24

Category

MED

Included in IECEE System

2007-10-01

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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

94342 Strasskirchen

Germany

Seoul

Korea, Republic of

Pointe Claire

Canada

Toronto

Canada

Arnhem

Netherlands

Fehraltorf

Switzerland

Reichenwalde b. Berlin

Germany

Modiin

Israel

Milano

Italy

Boxborough,

United States of America

Kaufbeuren

Germany

Duluth,

United States of America

Menlo Park,

United States of America

Kista

Sweden

Shanghai

China

Guangzhou, Guangdong

China

Osaka

Japan

Tokyo

Japan

Fontenay-Aux-Roses

France

TRAPPES

France

Oak Creek

United States of America

Toronto

Canada

Tampere

Finland

Helsinki

Finland

Munich

Germany

Suwanee

United States of America

Ljubljana

Slovenia

Tel-Aviv

Israel

Budapest

Hungary

Yokohama,

Japan

Nürnberg

Germany

Taoyuan City 333

Chinese Taipei

Peabody

United States of America

New Brighton

United States of America

San Diego

United States of America

GORMLEY

Canada

Jiangsu

China

Tokyo 160-0023

Japan

Singapore 609937

Singapore

Hannover

Germany

München

Germany

Fremont,

United States of America

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

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13372

Fehraltorf

Switzerland

13348

Reichenwalde b. Berlin

Germany

20269

Modiin

Israel

13351

Milano

Italy

13371

Kista

Sweden

13365

Singapore

Singapore

13424

IL 60005

United States of America

13353

Tokyo

Japan

13343

Fontenay-Aux-Roses

France

13641

Paris Cedex 15

France

13469

Toronto,

Canada

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

13423

Northbrook

United States of America

13344

Offenbach / Main

Germany

Id

Name

City

Country

26080

Beaucouzé

France

13339

Praha 8 - Troja 171 02

Czech Republic

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13359

Gyeonggi-do

Korea, Republic of

13356

Seoul

Korea, Republic of

13340

Ballerup

Denmark

13364

Warsaw

Poland