IEC 60601-2-65:2012

Title
Abstract

IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.

Issue Date

2012-09-19

Category

MED

Included in IECEE System

2012-10-16

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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

2016-02-27

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Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

94342 Strasskirchen

Germany

Seoul

Korea, Republic of

Pointe Claire

Canada

Yongin-si

Korea, Republic of

Gyeonggi-do

Korea, Republic of

Gimpo-si

Korea, Republic of

Milano

Italy

Boxborough,

United States of America

Kista

Sweden

Shanghai

China

Guangzhou, Guangdong

China

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Gyeonggi-do

Korea, Republic of

Gyeonggi-do 12735

Korea, Republic of

Tampere

Finland

Helsinki

Finland

Munich

Germany

Gunpo-si

Korea, Republic of

Shanghai

China

Guangzhou

China

Gyeonggi-do

Korea, Republic of

Shanghai

China

Budapest

Hungary

Yokohama,

Japan

München

Germany

Ballerup

Denmark

Mie 516-0021

Japan

Uiwang-si

Korea, Republic of

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13351

Milano

Italy

13371

Kista

Sweden

13365

Singapore

Singapore

13424

IL 60005

United States of America

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13359

Gyeonggi-do

Korea, Republic of

13356

Seoul

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13349

Budapest

Hungary

13354

Yokohama

Japan

13345

Nürnberg

Germany

13346

München

Germany

13340

Ballerup

Denmark

13423

Northbrook

United States of America

13344

Offenbach / Main

Germany

Id

Name

City

Country

13607

Baltimore,

United States of America

13348

Reichenwalde b. Berlin

Germany