IEC 60601-2-36:2014

Title
Abstract

IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. The applicability of this particular standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices. Other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to ultrasound physiotherapy equipment intended to be used for physiotherapy; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.

Issue Date

2014-04-10

Category

MED

Included in IECEE System

2014-05-14

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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.

Group/Country

Reference

Last Modified

Differences

TRF Addendum

CanadaCanada

2023-09-21

Download70 kb

CanadaCanada

2016-10-22

Download114 kb

Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

94342 Strasskirchen

Germany

Arnhem

Netherlands

Guangzhou

China

Dresden

Germany

Stuttgart

Germany

Regensdorf

Switzerland

182 00 Praha 8 – Troja

Czech Republic

Modiin

Israel

Kaufbeuren

Germany

Shanghai

China

Seoul 08389

Korea, Republic of

Munich

Germany

Shanghai

China

Guangzhou

China

Hartmannsdorf

Germany

Nürnberg

Germany

San Diego

United States of America

München

Germany

Northbrook, IL 60062

United States of America

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13339

Praha 8 - Troja 171 02

Czech Republic

13372

Fehraltorf

Switzerland

20269

Modiin

Israel

13371

Kista

Sweden

13356

Seoul

Korea, Republic of

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13347

Hartmannsdorf

Germany

13345

Nürnberg

Germany

13346

München

Germany

13340

Ballerup

Denmark

13423

Northbrook

United States of America

No information declared