IEC 80601-2-30:2009

Title
Abstract

IEC 80601-2-30:2009 applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It covers electrically-powered intermittent, indirect measurement of the blood pressure without arterial puncture, me equipment with automatic methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment. This first edition of IEC 80601-2-30 cancels and replaces the second edition of IEC 60601-2-30, published in 1999. This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system. The contents of the corrigendum of January 2010 have been included in this copy.

Issue Date

2009-01-28

Category

MED

Included in IECEE System

2009-06-30

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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

Shanghai

China

94447 Plattling

Germany

Seoul

Korea, Republic of

Pointe Claire

Canada

Stuttgart

Germany

New Taipei City

Chinese Taipei

Reichenwalde b. Berlin

Germany

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

United Kingdom

Guangzhou, Guangdong

China

Taipei City

Chinese Taipei

Osaka

Japan

Tokyo

Japan

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Oak Creek

United States of America

Carlsbad,

United States of America

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Gyeonggi-do 12735

Korea, Republic of

Tampere

Finland

Helsinki

Finland

Puchheim

Germany

Madrid

Spain

Shanghai

China

Guangzhou

China

Ljubljana

Slovenia

Bangalore – 560 100

India

Shanghai

China

Shenzhen

China

Budapest

Hungary

Yokohama,

Japan

Seoul, 07298

Korea, Republic of

Taoyuan City 333

Chinese Taipei

Boxborough, MA 01719

United States of America

Pleasanton,

United States of America

San Diego

United States of America

GORMLEY L0H 1G0

Canada

Guangzhou

China

Tokyo

Japan

Singapore 609937

Singapore

München

Germany

Bengaluru

India

Mie 516-0021

Japan

Uiwang-si

Korea, Republic of

Melville

United States of America

Northbrook, IL 60062

United States of America

Research Triangle Park

United States of America

Huangpu District, Guangzhou

China

Kyiv

Ukraine

Taipei City

Chinese Taipei

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13607

Baltimore,

United States of America

13348

Reichenwalde b. Berlin

Germany

20269

Modiin

Israel

13371

Kista

Sweden

13375

Surrey

United Kingdom

13365

Singapore

Singapore

13424

IL 60005

United States of America

13353

Tokyo

Japan

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13359

Gyeonggi-do

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

13374

Kyiv

Ukraine

13344

Offenbach / Main

Germany