Standard

IEC 61010-2-040:2015

Title	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
Abstract	IEC 61010-2-040:2015 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. It has the status of a group safety publication, as specified in IEC Guide 104. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) A new clause (4.3.2.101) has been added for non-electrical supplies and services. b) Additional requirements for marking and documentation (Clause 5) have been added. c) Additional requirements for protection against mechanical hazards (Clause 7) have been included. d) Additional requirements for protection against radiation, including laser sources, and against sonic and ultrasonic pressure (Clause 12) have been included.
Issue Date	2015-07-07
Category	MEAS
Included in IECEE System	2015-08-04
Purchase	webstore
Test Report Form	IEC61010_2_040B
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.

Group/Country	Reference	Last Modified	Differences	TRF Addendum
Canada	CAN/CSA C22.2 61010-2-040:16	2017-05-25	Download52 kb

Laboratory Name	City	Country	Responsible National Certification Body
Analytical S.r.l.	Scandicci (FI)	Italy	DEKRA Certification B.V.
CSA Group Bayern GmbH	94342 Strasskirchen	Germany	CSA Group
CSA Group Japan Ltd.	Tokyo	Japan	CSA Group
CSA Group Testing & Certification Inc. (Toronto)	Toronto	Canada	CSA Group
DEKRA Certification B.V.	Arnhem	Netherlands	DEKRA Certification B.V.
DEKRA Testing and Certification S.A.U.	Campanillas	Spain	DEKRA Certification B.V.
EMITECH Lyon	Chassieu	France	EMITECH SAS
Element Materials Technology (Irvine)	Irvine	United States of America	Element Materials Technology
Eurofins Electric & Electronic Product Testing AG, Lab Fehraltorf	Fehraltorf	Switzerland	Eurofins Electric & Electronic Product Testing AG
Eurofins Electrical Testing Service (Shanghai) Co., Ltd	Shanghai	China	Eurofins Product Service GmbH
Eurofins Product Service GmbH	Reichenwalde b. Berlin	Germany	Eurofins Product Service GmbH
I.T.L. (Product Testing) Ltd.	Modiin	Israel	I.T.L. (Product Testing) Ltd.
IMQ S.p.A. – Milano	Milano	Italy	IMQ S.p.A.
Intertek Boxborough	Boxborough,	United States of America	Intertek Testing Services NA, Inc.
Intertek Columbus	Columbus,	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 Italia S.p.A.	Campoformido (UD)	Italy	Intertek Semko AB
Intertek Plano	Plano,	United States of America	Intertek Testing Services NA, Inc.
Intertek Semko AB	Kista	Sweden	Intertek Semko AB
Intertek Testing Services Shenzhen Ltd. Guangzhou Branch	Guangzhou, Guangdong	China	Intertek Testing Services (Singapore) Pte Ltd
Japan Quality Assurance Organization, Safety & EMC Center - JQA Tokyo	Tokyo	Japan	Japan Quality Assurance Organization (JQA)
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
NEMKO S.p.A. Italy	Biassono (MB)	Italy	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
QPS Evaluation Services Inc.	Toronto	Canada	QPS Evaluation Services, Inc.
SGS Fimko Ltd.	Helsinki	Finland	SGS Fimko Ltd
SGS Germany GmbH Munich	Puchheim	Germany	SGS Belgium N.V. − Division SGS-CEBEC
SGS Korea Co., Ltd.	Gunpo-si	Korea, Republic of	SGS Fimko Ltd
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
SIQ Ljubljana	Ljubljana	Slovenia	SIQ Ljubljana
The Standards Institution of Israel (SII)	Tel-Aviv	Israel	SII
TÜV Italia srl	Volpiano (TO)	Italy	TÜV SÜD Product Service GmbH
TÜV Rheinland (Shenzhen) Co., Ltd.	Nanshan District	China	TÜV Rheinland LGA Products GmbH
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 Berlin	Berlin	Germany	TÜV Rheinland LGA Products GmbH
TÜV Rheinland LGA Products GmbH Köln	Köln	Germany	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 Product Service GmbH Frankfurt	Frankfurt	Germany	TÜV SÜD Product Service GmbH
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 International Italia S.r.l.	20061 Carugate (MI)	Italy	UL Solutions (Demko)
UL Japan, Inc.	Mie 516-0021	Japan	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 Solutions Northbrook	Northbrook, IL 60062	United States of America	UL Solutions (US)
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
13478	Element Materials Technology	Skelmersdale	United Kingdom
13372	Eurofins Electric & Electronic Product Testing AG	Fehraltorf	Switzerland
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
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
13356	Korea Testing Laboratory (KTL)	Seoul	Korea, Republic of
13343	LABORATOIRE CENTRAL DES INDUSTRIES ELECTRIQUES – LCIE	Fontenay-Aux-Roses	France
13361	Nemko Group AS	Lysaker	Norway
13469	QPS Evaluation Services, Inc.	Toronto,	Canada
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
13354	TÜV Rheinland Japan Ltd.	Yokohama	Japan
13345	TÜV Rheinland LGA Products GmbH	Nürnberg	Germany
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
13427	TÜV SÜD PSB Pte. Ltd.	Singapore 609937	Singapore