Standard

IEC 60601-2-18:2009

Title	Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
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
Purchase	webstore
Test Report Form	IEC60601_2_18F
Testing Equipment List	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.

No information declared

Laboratory Name	City	Country	Responsible National Certification Body
ACTS Co., Ltd.	Suwon-si	Korea, Republic of	UL Solutions (Demko)
Bureau Veritas Consumer Products Services, Inc.	Littleton 01460	United States of America	LABORATOIRE CENTRAL DES INDUSTRIES ELECTRIQUES – LCIE
CCIC-CSA International Certification Co. Ltd. Shanghai Branch	Shanghai	China	CSA Group
CEcert GmbH	Wismar	Germany	UL Solutions (Demko)
CSA Group Bayern GmbH	94342 Strasskirchen	Germany	CSA Group
CSA Group Korea Ltd.	Seoul	Korea, Republic of	CSA Group
CSA Group Testing & Certification Inc. (Pointe Claire)	Pointe Claire	Canada	CSA Group
CSA Group Testing & Certification Inc. (Toronto)	Toronto	Canada	CSA Group
CSA Group – Irvine	Irvine	United States of America	CSA Group
DEKRA Certification B.V.	Arnhem	Netherlands	DEKRA Certification B.V.
DEKRA Testing and Certification (Shanghai) Ltd., Guangzhou branch	Guangzhou	China	DEKRA Certification B.V.
DEKRA Testing and Certification GmbH	Dresden	Germany	DEKRA Certification B.V.
DEKRA Testing and Certification GmbH, Stuttgart Laboratory	Stuttgart	Germany	DEKRA Certification B.V.
DEKRA Testing and Certification S.A.U.	Campanillas	Spain	DEKRA Certification B.V.
Dt&C Co., Ltd.	Yongin-si	Korea, Republic of	UL Solutions (Demko)
EMITECH Lyon	Chassieu	France	EMITECH SAS
Eurofins E&E Taiwan Co., Ltd.	New Taipei City	Chinese Taipei	Eurofins Electrical and Electronic Testing NA, Inc.
Eurofins Electrical Testing Service (Shanghai) Co., Ltd	Shanghai	China	Eurofins Product Service GmbH
Eurofins Electrical and Electronic Testing NA, Inc. (Baltimore)	Baltimore, MD 21230-3432	United States of America	Eurofins Electrical and Electronic Testing NA, Inc.
HCT Co., Ltd.	Gyeonggi-Do	Korea, Republic of	Korea Testing & Research Institute (KTR)
I.T.L. (Product Testing) Ltd.	Modiin	Israel	I.T.L. (Product Testing) Ltd.
ICR Co., Ltd.	Gimpo-si	Korea, Republic of	Korea Testing & Research Institute (KTR)
IMQ S.p.A. – Milano	Milano	Italy	IMQ S.p.A.
Intertek Boxborough	Boxborough,	United States of America	Intertek Testing Services NA, Inc.
Intertek Deutschland GmbH, Kaufbeuren	Kaufbeuren	Germany	Intertek Semko AB
Intertek Duluth	Duluth,	United States of America	Intertek Testing Services NA, Inc.
Intertek Japan K.K. Tokyo Laboratory	Tokyo	Japan	Intertek Semko AB
Intertek Lake Forest	Lake Forest,	United States of America	Intertek Testing Services NA, Inc.
Intertek Menlo Park	Menlo Park,	United States of America	Intertek Testing Services NA, Inc.
Intertek Minnesota	Fridley, MN	United States of America	Intertek Testing Services NA, Inc.
Intertek Plano	Plano,	United States of America	Intertek Testing Services NA, Inc.
Intertek Testing & Certification Ltd. - Leatherhead		United Kingdom	Intertek Testing & Certification Ltd.
Intertek Testing Services Shanghai	Shanghai	China	Intertek Semko AB
Intertek Testing Services Shenzhen Ltd. Guangzhou Branch	Guangzhou, Guangdong	China	Intertek Testing Services (Singapore) Pte Ltd
Japan Quality Assurance Organization, Kita-Kansai Testing Center - JQA Kita Kansai	Osaka	Japan	Japan Quality Assurance Organization (JQA)
Japan Quality Assurance Organization, Safety & EMC Center - JQA Tokyo	Tokyo	Japan	Japan Quality Assurance Organization (JQA)
Korea Testing & Research Institute (KTR)	Gyeonggi-do	Korea, Republic of	Korea Testing & Research Institute (KTR)
Korea Testing Laboratory (KTL)	Seoul 08389	Korea, Republic of	Korea Testing Laboratory (KTL)
LABORATOIRE CENTRAL DES INDUSTRIES ELECTRIQUES – LCIE	Fontenay-Aux-Roses	France	LABORATOIRE CENTRAL DES INDUSTRIES ELECTRIQUES – LCIE
Laboratoire National de Métrologie et d'Essais (LNE)	TRAPPES	France	Laboratoire National de Métrologie et d’Essais (LNE)
Medical Equipment Compliance Associates, LLC (MECA)	Oak Creek	United States of America	UL Solutions (US)
NEMKO USA Inc., (San Diego) USA	Carlsbad,	United States of America	Nemko Group AS
Nemko GmbH	Pfinztal	Germany	Nemko Group AS
Nemko Korea Co., Ltd.	Gyeonggi-do	Korea, Republic of	Nemko Group AS
Nemko Scandinavia AS	Lysaker	Norway	Nemko Group AS
Nemko Shanghai Ltd. Shenzhen Branch	Shenzhen, Guangdong	China	Nemko Group AS
ONETECH Corp	Gyeonggi-do 12735	Korea, Republic of	KTC - Korea Testing Certification Institute
SGS Germany GmbH Munich	Puchheim	Germany	SGS Belgium N.V. − Division SGS-CEBEC
SGS Japan Inc. Safety Laboratory	Yokohama	Japan	SGS Belgium N.V. − Division SGS-CEBEC
SGS North America, Inc.	Suwanee	United States of America	SGS Belgium N.V. − Division SGS-CEBEC
SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd.	Shanghai	China	SGS Belgium N.V. − Division SGS-CEBEC
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch	Guangzhou	China	SGS Fimko Ltd
SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch	Shenzhen	China	SGS Fimko Ltd
SIQ Ljubljana	Ljubljana	Slovenia	SIQ Ljubljana
SLG Prüf- und Zertifizierungs GmbH	Hartmannsdorf	Germany	SLG Prüf- und Zertifizierungs GmbH
STC (Guangdong) Company Limited	Dongguan	China	Nemko Group AS
Standard Bank Co., Ltd.	Gyeonggi-do	Korea, Republic of	Korea Testing & Research Institute (KTR)
The Standards Institution of Israel (SII)	Tel-Aviv	Israel	SII
TÜV Rheinland (Shanghai) Co., Ltd.	Shanghai	China	TÜV Rheinland LGA Products GmbH
TÜV Rheinland (Shenzhen) Co., Ltd.	Nanshan District	China	TÜV Rheinland LGA Products GmbH
TÜV Rheinland InterCert Kft., MEEI Division	Budapest	Hungary	TÜV Rheinland InterCert Kft., MEEI Division
TÜV Rheinland Japan Ltd., Osaka Laboratory	Osaka 537-0002,	Japan	TÜV Rheinland Japan Ltd.
TÜV Rheinland Japan, Ltd. Yokohama Laboratory	Yokohama,	Japan	TÜV Rheinland Japan Ltd.
TÜV Rheinland Korea Ltd.	Seoul, 07298	Korea, Republic of	TÜV Rheinland Japan Ltd.
TÜV Rheinland LGA Products GmbH Nürnberg	Nürnberg	Germany	TÜV Rheinland LGA Products GmbH
TÜV Rheinland Taiwan Ltd., Taoyuan Testing Laboratories	Taoyuan City 333	Chinese Taipei	TÜV Rheinland LGA Products GmbH
TÜV Rheinland of North America, Inc. Boxborough	Boxborough, MA 01719	United States of America	TÜV Rheinland LGA Products GmbH
TÜV Rheinland of North America, Inc. Pleasanton	Pleasanton,	United States of America	TÜV Rheinland LGA Products GmbH
TÜV SÜD America Inc., San Diego CA	San Diego	United States of America	TÜV SÜD Product Service GmbH
TÜV SÜD Canada, Inc.	GORMLEY	Canada	TÜV SÜD Product Service GmbH
TÜV SÜD Certification and Testing (China) Co., Ltd.	Jiangsu	China	TÜV SÜD PSB Pte. Ltd.
TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch	Guangzhou	China	TÜV SÜD PSB Pte. Ltd.
TÜV SÜD Japan Ltd. Tokyo Testing Center	Tokyo 160-0023	Japan	TÜV SÜD PSB Pte. Ltd.
TÜV SÜD Product Service GmbH Munich	München	Germany	TÜV SÜD Product Service GmbH
UL International Demko A/S	Ballerup	Denmark	UL Solutions (Demko)
UL International Germany GmbH	Neu-Isenburg (Zeppelinheim)	Germany	UL Solutions (Demko)
UL Japan, Inc.	Mie 516-0021	Japan	UL Solutions (US)
UL Korea Ltd.	Uiwang-si	Korea, Republic of	UL Solutions (Demko)
UL Solutions Fremont	Fremont,	United States of America	UL Solutions (US)
UL Solutions Melville	Melville	United States of America	UL Solutions (US)
UL Solutions Minneapolis	Mounds View	United States of America	UL Solutions (US)
UL-CCIC Company Limited	Suzhou	China	UL Solutions (Demko)
Underwriters Laboratories Taiwan Co., Ltd	Taipei City	Chinese Taipei	UL Solutions (Demko)
VDE Prüf- und Zertifizierungsinstitut GmbH	Offenbach / Main	Germany	VDE Prüf- und Zertifizierungsinstitut GmbH

Id	Name	City	Country
13336	CSA Group	Toronto, Ontario	Canada
13360	DEKRA Certification B.V.	Arnhem	Netherlands
26080	EMITECH SAS	Beaucouzé	France
13607	Eurofins Electrical and Electronic Testing NA, Inc.	Baltimore,	United States of America
13348	Eurofins Product Service GmbH	Reichenwalde b. Berlin	Germany
20269	I.T.L. (Product Testing) Ltd.	Modiin	Israel
13351	IMQ S.p.A.	Milano	Italy
13371	Intertek Semko AB	Kista	Sweden
13375	Intertek Testing & Certification Ltd.	Surrey	United Kingdom
13365	Intertek Testing Services (Singapore) Pte Ltd	Singapore	Singapore
13424	Intertek Testing Services NA, Inc.	IL 60005	United States of America
13353	Japan Quality Assurance Organization (JQA)	Tokyo	Japan
13358	KTC - Korea Testing Certification Institute	Gunpo-si,Gyeonggi-do, 15809	Korea, Republic of
13359	Korea Testing & Research Institute (KTR)	Gyeonggi-do	Korea, Republic of
13356	Korea Testing Laboratory (KTL)	Seoul	Korea, Republic of
13343	LABORATOIRE CENTRAL DES INDUSTRIES ELECTRIQUES – LCIE	Fontenay-Aux-Roses	France
13641	Laboratoire National de Métrologie et d’Essais (LNE)	Paris Cedex 15	France
13361	Nemko Group AS	Lysaker	Norway
13334	SGS Belgium N.V. − Division SGS-CEBEC	BRUSSELS 1070	Belgium
13342	SGS Fimko Ltd	Helsinki	Finland
13597	SII	Tel-Aviv	Israel
13367	SIQ Ljubljana	Ljubljana	Slovenia
13347	SLG Prüf- und Zertifizierungs GmbH	Hartmannsdorf	Germany
13349	TÜV Rheinland InterCert Kft., MEEI Division	Budapest	Hungary
13354	TÜV Rheinland Japan Ltd.	Yokohama	Japan
13345	TÜV Rheinland LGA Products GmbH	Nürnberg	Germany
13427	TÜV SÜD PSB Pte. Ltd.	Singapore 609937	Singapore
13346	TÜV SÜD Product Service GmbH	München	Germany
13340	UL Solutions (Demko)	Ballerup	Denmark
13423	UL Solutions (US)	Northbrook	United States of America
13344	VDE Prüf- und Zertifizierungsinstitut GmbH	Offenbach / Main	Germany

Id	Name	City	Country
13721	BELLIS Testing and Certification of Home Appliances and Industrial Products JSC	Minsk	Belarus