IEC 60601-2-37:2007

Title
Abstract

Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005.

Issue Date

2007-08-09

Category

MED

Included in IECEE System

2007-11-30

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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

Suwon-si

Korea, Republic of

Shanghai

China

94342 Strasskirchen

Germany

Seoul

Korea, Republic of

Toronto

Canada

Irvine

United States of America

Arnhem

Netherlands

Guangzhou

China

Yongin-si

Korea, Republic of

New Taipei City

Chinese Taipei

Shanghai

China

Aix en Provence

France

Baltimore, MD 21230-3432

United States of America

Gyeonggi-do

Korea, Republic of

Reichenwalde b. Berlin

Germany

Binyamina

Israel

Modiin

Israel

Milano

Italy

Boxborough,

United States of America

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

Plano,

United States of America

United Kingdom

Shanghai

China

Guangzhou, Guangdong

China

Tokyo

Japan

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

TRAPPES

France

Oak Creek

United States of America

Carlsbad,

United States of America

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Munich

Germany

Yokohama

Japan

Suwanee

United States of America

Taiwan 248

Chinese Taipei

Shanghai

China

Guangzhou

China

Bangalore – 560 100

India

Tel-Aviv

Israel

Shanghai

China

Nanshan District

China

Budapest

Hungary

Osaka 537-0002,

Japan

Yokohama,

Japan

Seoul, 07298

Korea, Republic of

Taoyuan City 333

Chinese Taipei

Boxborough, MA 01719

United States of America

Pleasanton,

United States of America

GORMLEY

Canada

Guangzhou 510656

China

Tokyo 160-0023

Japan

Singapore 609937

Singapore

München

Germany

Ballerup

Denmark

Mie 516-0021

Japan

Uiwang-si

Korea, Republic of

Fremont,

United States of America

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

21201

Binyamina

Israel

20269

Modiin

Israel

13351

Milano

Italy

13371

Kista

Sweden

13375

Surrey

United Kingdom

13365

Singapore

Singapore

13424

IL 60005

United States of America

13353

Tokyo

Japan

13359

Gyeonggi-do

Korea, Republic of

13356

Seoul

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13641

Paris Cedex 15

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

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

Id

Name

City

Country

26080

Beaucouzé

France