IEC 60601-2-18:2009

Title
Abstract

IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include:
- alignment of requirements with IEC 60601-1:2005;
- inclusion of essential performance requirements;
- the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard;
- reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.

Issue Date

2009-08-12

Category

MED

Included in IECEE System

2010-02-01

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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

Littleton 01460

United States of America

Shanghai

China

Wismar

Germany

94447 Plattling

Germany

Seoul

Korea, Republic of

Pointe Claire

Canada

Toronto

Canada

Irvine

United States of America

Arnhem

Netherlands

Guangzhou

China

Suzhou

China

Dresden

Germany

Stuttgart

Germany

Campanillas

Spain

Yongin-si

Korea, Republic of

Chassieu

France

New Taipei City

Chinese Taipei

Shanghai

China

Aix en Provence

France

Baltimore, MD 21230-3432

United States of America

Irvine

United States of America

Gyeonggi-do

Korea, Republic of

Gyeonggi-Do

Korea, Republic of

Modiin

Israel

Gimpo-si

Korea, Republic of

Milano

Italy

Boxborough,

United States of America

Kaufbeuren

Germany

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

Osaka

Japan

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

Pfinztal

Germany

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Shenzhen, Guangdong

China

Gyeonggi-do 12735

Korea, Republic of

Puchheim

Germany

Yokohama

Japan

Suwanee

United States of America

Shanghai

China

Guangzhou

China

Shenzhen

China

Wuhan

China

Ljubljana

Slovenia

Hartmannsdorf

Germany

Dongguan

China

Gyeonggi-do

Korea, Republic of

Tel-Aviv

Israel

Shanghai

China

Shenzhen

China

Budapest

Hungary

Osaka 537-0002,

Japan

Yokohama,

Japan

Seoul, 07298

Korea, Republic of

Nürnberg

Germany

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

Jiangsu

China

Guangzhou

China

Tokyo

Japan

München

Germany

Ballerup

Denmark

Neu-Isenburg (Zeppelinheim)

Germany

Mie 516-0021

Japan

Uiwang-si

Korea, Republic of

Fremont,

United States of America

Melville

United States of America

Mounds View

United States of America

Research Triangle Park

United States of America

Suzhou

China

Taipei City

Chinese Taipei

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

26080

Beaucouzé

France

13607

Baltimore,

United States of America

13348

Reichenwalde b. Berlin

Germany

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

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13359

Gyeonggi-do

Korea, Republic of

13356

Gyeongsangnam-do

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

13367

Ljubljana

Slovenia

13347

Hartmannsdorf

Germany

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

13344

Offenbach / Main

Germany