IEC 60601-1-6:2006

Title
Abstract

Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.

Issue Date

2006-12-08

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

Littleton, MA

United States of America

Wismar

Germany

94342 Strasskirchen

Germany

Seoul

Korea, Republic of

Pointe Claire

Canada

Richmond

Canada

Toronto

Canada

Arnhem

Netherlands

Yongin-si

Korea, Republic of

182 00 Praha 8 – Troja

Czech Republic

Fehraltorf

Switzerland

Reichenwalde b. Berlin

Germany

Milano

Italy

Boxborough,

United States of America

Columbus,

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

Plano,

United States of America

Kista

Sweden

United Kingdom

Shanghai

China

Guangzhou, Guangdong

China

Osaka

Japan

Tokyo

Japan

Fontenay-Aux-Roses

France

TRAPPES

France

Oak Creek

United States of America

Ottawa

Canada

Carlsbad,

United States of America

Pfinztal

Germany

Lysaker

Norway

Shenzhen, Guangdong

China

Toronto

Canada

Tampere

Finland

Helsinki

Finland

Munich

Germany

Gunpo-si

Korea, Republic of

Suwanee

United States of America

Shanghai

China

Ljubljana

Slovenia

Hartmannsdorf

Germany

Genas

France

Tel-Aviv

Israel

Budapest

Hungary

Yokohama,

Japan

Seoul, 07298

Korea, Republic of

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

Singapore 609937

Singapore

Hannover

Germany

Warszawa

Poland

Mie 516-0021

Japan

Seoul

Korea, Republic of

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

13864

COURBEVOIE

France

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13339

Praha 8 - Troja 171 02

Czech Republic

13372

Fehraltorf

Switzerland

13348

Reichenwalde b. Berlin

Germany

13351

Milano

Italy

13371

Kista

Sweden

13375

Surrey

United Kingdom

13365

Singapore

Singapore

13424

IL 60005

United States of America

13353

Tokyo

Japan

13343

Fontenay-Aux-Roses

France

13641

Paris Cedex 15

France

13361

Lysaker

Norway

13469

Toronto,

Canada

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

13367

Ljubljana

Slovenia

13347

Hartmannsdorf

Germany

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

13359

Gyeonggi-do

Korea, Republic of