IEC 60601-1-10:2007

Title
Abstract

Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a physiologic variable. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard applies to a closed-loop controller that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable.

Issue Date

2007-11-21

Category

MED

Included in IECEE System

2008-02-25

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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

Shanghai

China

Wismar

Germany

Seoul

Korea, Republic of

Pointe Claire

Canada

Toronto

Canada

Arnhem

Netherlands

Guangzhou

China

Reichenwalde b. Berlin

Germany

Hørsholm 2970

Denmark

Modiin

Israel

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

Kista

Sweden

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Moirans

France

Carlsbad,

United States of America

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Puchheim

Germany

Shanghai

China

Guangzhou

China

Budapest

Hungary

Taoyuan City 333

Chinese Taipei

New Brighton

United States of America

San Diego

United States of America

Jiangsu

China

München

Germany

Ballerup

Denmark

Northbrook, IL 60062

United States of America

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13348

Reichenwalde b. Berlin

Germany

21077

Broendby

Denmark

20269

Modiin

Israel

13351

Milano

Italy

13371

Kista

Sweden

13424

IL 60005

United States of America

13356

Gyeongsangnam-do

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13349

Budapest

Hungary

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

13607

Baltimore,

United States of America

13353

Tokyo

Japan

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13359

Gyeonggi-do

Korea, Republic of

13373

Bakanliklar, Ankara

Türkiye