IEC IEC 61010-2-101 Edition 3.02018-10 REDLINEVERSION colour inside GROUP SAFETY PUBLICATION Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IvD) medical equipment IEC 61010-2-101:2018-10 RLV(en) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright @ 2018 IEC, Geneva, Switzerland or by any means, electronic or mechanical, including photocopying and microfim, without permission in writing from copyright or have an enquiry about obtaining additional rights to this publication, piease contact the address below or your local IEC member National Committee for further information. IEC Central Office Tel.: +41 22 919 02 11 3, rue de Varembé [email protected] CH-1211 Geneva 20 www.iec.ch Switzerland AbouttheIEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies AboutIECpublications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. IEc Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org Thestand-alone applicationforconsulting theentire The world's leading online dictionary of electronic and bibliographical information on IEc International Standards, electrical terms containing 21 000 terms and definitions in Technical Specifications, Technical Reports andother English and French, with equivalent terms in 16 additional documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical iPad. Vocabulary (IEV)online IECpublicationssearch-webstore.iec.ch/advsearchform IEc Glossary-std.iec.ch/glossary The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and variety. of criteria (reference number, text,technical French extracted from the Terms and Definitions clause of committee...). It also gives information on projects, replaced IEC publications issued since 2002.Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and and withdrawn publications. CISPR. IECJustPublished-webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published IEc Customer Service Centre - webstore.iec.ch/csc details all new publications released. Available online and If you wish to give us your feedback on this publication or also once a month by email. need further assistance, please contact the Customer Service Centre: [email protected]. IEC IEC61010-2-101 Edition 3.0 2018-10 REDLINEVERSION colour inside GROUP SAFETY PUBLICATION Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IvD) medical equipment INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.55; 19.080 ISBN 978-2-8322-6114-9 Warning! Make sure that you obtained this publication from an authorized distributor. ?Registe