IEC 60601-2-62:2013

Title
Abstract

IEC 60601-2-62:2013 applies to the basic safety and essential performance of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. If a clause or subclause is specifically intended to be applicable to such equipment only, or to related systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to individual equipment and to systems, as relevant. Hazards inherent in the intended physiological function of the equipment or systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This standard can also be applied to
- therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound;
- therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound;
- and equipment intended to be used for relieving cancer pain due to bone metastases.
This particular standard does not apply to
- Ultrasound Equipment intended to be used for physiotherapy (use IEC 60601-2-5 and IEC 61689);
- Ultrasound Equipment intended to be used for lithotripsy (use IEC 60601-2-36);
- Ultrasound Equipment intended to be used for dedicated hyperthermia devices; and
- Ultrasound Equipment intended to be used for phacoemulsification.

Issue Date

2013-07-09

Category

MED

Included in IECEE System

2014-01-29

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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.

Group/Country

Reference

Last Modified

Differences

TRF Addendum

CanadaCanada

2019-07-23

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Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

Toronto

Canada

Guangzhou

China

New Taipei City

Chinese Taipei

Gyeonggi-do

Korea, Republic of

Binyamina

Israel

Modiin

Israel

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Carlsbad,

United States of America

Gyeonggi-do

Korea, Republic of

Tampere

Finland

Gunpo-si

Korea, Republic of

Gyeonggi-do

Korea, Republic of

Tel-Aviv

Israel

Nanshan District

China

München

Germany

Uiwang-si

Korea, Republic of

Northbrook, IL 60062

United States of America

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13607

Baltimore,

United States of America

21201

Binyamina

Israel

20269

Modiin

Israel

13359

Gyeonggi-do

Korea, Republic of

13356

Seoul

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

13345

Nürnberg

Germany

13346

München

Germany

13340

Ballerup

Denmark

13423

Northbrook

United States of America

Id

Name

City

Country

13348

Reichenwalde b. Berlin

Germany

13371

Kista

Sweden