IEC 60601-2-34:2011

Title
Abstract

IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.

Issue Date

2011-05-19

Category

MED

Included in IECEE System

2011-08-25

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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

Suwon-si

Korea, Republic of

Shanghai

China

Wismar

Germany

Seoul

Korea, Republic of

Pointe Claire

Canada

Toronto

Canada

Guangzhou

China

Baltimore, MD 21230-3432

United States of America

Modiin

Israel

Boxborough,

United States of America

Duluth,

United States of America

Lake Forest,

United States of America

Plano,

United States of America

Kista

Sweden

Guangzhou, Guangdong

China

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Oak Creek

United States of America

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Tampere

Finland

Helsinki

Finland

Puchheim

Germany

Madrid

Spain

Shanghai

China

Guangzhou

China

Shenzhen

China

Ljubljana

Slovenia

Dongguan

China

Nanshan District

China

Budapest

Hungary

Yokohama,

Japan

Taoyuan City 333

Chinese Taipei

Pleasanton,

United States of America

Peabody

United States of America

San Diego

United States of America

Jiangsu

China

Guangzhou

China

München

Germany

Mie 516-0021

Japan

Uiwang-si

Korea, Republic of

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

Huangpu District, Guangzhou

China

Taipei City

Chinese Taipei

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13607

Baltimore,

United States of America

20269

Modiin

Israel

13371

Kista

Sweden

13365

Singapore

Singapore

13424

IL 60005

United States of America

13356

Seoul

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

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