IEC 60601-1-4:1996

Title
Abstract

Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk.This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.

Issue Date

1996-05-31

Category

MED

Included in IECEE System

2007-10-01

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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

Wismar

Germany

94342 Strasskirchen

Germany

Pointe Claire

Canada

Irvine

United States of America

Arnhem

Netherlands

Dresden

Germany

Stuttgart

Germany

182 00 Praha 8 – Troja

Czech Republic

Baltimore, MD 21230-3432

United States of America

Reichenwalde b. Berlin

Germany

Binyamina

Israel

Milano

Italy

Boxborough,

United States of America

Kaufbeuren

Germany

Duluth,

United States of America

Tokyo

Japan

Lake Forest,

United States of America

Menlo Park,

United States of America

Fridley, MN

United States of America

Kista

Sweden

United Kingdom

Shanghai

China

Guangzhou, Guangdong

China

Fontenay-Aux-Roses

France

Moirans

France

TRAPPES

France

Carlsbad,

United States of America

Pfinztal

Germany

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Toronto

Canada

Tampere

Finland

Helsinki

Finland

Munich

Germany

Suwanee

United States of America

Madrid

Spain

Shanghai

China

Guangzhou

China

Ljubljana

Slovenia

Genas

France

Bangalore – 560 100

India

Shanghai

China

Yokohama,

Japan

Nürnberg

Germany

Taoyuan City 333

Chinese Taipei

Pleasanton,

United States of America

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

Neu-Isenburg (Zeppelinheim)

Germany

Fremont,

United States of America

Melville

United States of America

Northbrook, IL 60062

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

13607

Baltimore,

United States of America

13348

Reichenwalde b. Berlin

Germany

21201

Binyamina

Israel

13351

Milano

Italy

13371

Kista

Sweden

13375

Surrey

United Kingdom

13365

Singapore

Singapore

13424

IL 60005

United States of America

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

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