1、 IEC 61326-2-6 Edition 2.0 2012-07 INTERNATIONAL STANDARD NORME INTERNATIONALE Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equipment Matriel lectrique de mesure, de commande et de laboratoire Ex
2、igences relatives la CEM Partie 2-6: Exigences particulires Matriel mdical de diagnostic in vitro (IVD) IEC 61326-2-6:2012 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or
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16、blication ou si vous avez des questions contactez-nous: csciec.ch. IEC 61326-2-6 Edition 2.0 2012-07 INTERNATIONAL STANDARD NORME INTERNATIONALE Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equip
17、ment Matriel lectrique de mesure, de commande et de laboratoire Exigences relatives la CEM Partie 2-6: Exigences particulires Matriel mdical de diagnostic in vitro (IVD) INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE L ICS 17.220; 19.080; 25.040.40; 33.100 PRICE
18、 CODE CODE PRIX ISBN 978-2-83220-210-4 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous a
19、vez obtenu cette publication via un distributeur agr. 2 61326-2-6 IEC:2012 CONTENTS FOREWORD . 3 1 Scope . 5 2 Normative references . 5 3 Terms and definitions . 5 4 General 6 4.101 Electromagnetic environment of IVD medical equipment 6 5 EMC test plan . 6 5.1 General . 6 5.2 Configuration of EUT du
20、ring testing . 6 5.3 Operation conditions of EUT during testing 6 5.3.101 Operational conditions . 6 5.4 Specification of functional performance . 6 5.5 Test description . 6 6 Immunity requirements . 7 6.1 Conditions during the tests 7 6.2 Immunity test requirements . 7 6.3 Random aspects 8 6.4 Perf
21、ormance criteria 9 7 Emission requirements . 9 8 Test results and test report . 9 9 Instructions for use . 9 9.1 Requirements for the IVD medical equipment instruction for use . 9 9.2 Instructions for IVD medical equipment for self-testing 9 9.3 Instructions for IVD medical equipment for professiona
22、l use 9 Annex A (normative) Immunity test requirements for portable test and measurement equipment powered by battery or from the circuit being measured 10 Bibliography 11 Table 101 Immunity requirements for IVD medical equipment 8 61326-2-6 IEC:2012 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ ELE
23、CTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE EMC REQUIREMENTS Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electro
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33、n this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying a
34、ny or all such patent rights. International Standard IEC 61326-2-6 has been prepared by subcommittee 65A: System aspects, of IEC technical committee 65: Industrial-process measurement, control and automation. This second edition cancels and replaces the first edition published in 2005. This edition
35、constitutes a technical revision. 4 61326-2-6 IEC:2012 This edition includes the following significant technical change with respect to the previous edition: update of the document with respect to IEC 61326-1:2012. The text of this standard is based on the following documents: FDIS Report on voting
36、65A/631/FDIS 65A/640/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. This part of the IEC 61326 series is to be used in conjunc
37、tion with IEC 61326-1:2012 and follows the same numbering of clauses, subclauses, tables and figures. When a particular subclause of IEC 61326-1 is not mentioned in this part, that subclause applies as far as is reasonable. When this standard states “addition”, “modification” or “replacement”, the r
38、elevant text in IEC 61326-1 is to be adapted accordingly. NOTE The following numbering system is used: subclauses, tables and figures that are numbered starting from 101 are additional to those in IEC 61326-1; unless notes are in a new subclause or involve notes in IEC 61326-1, they are numbered sta
39、rting from 101 including those in a replaced clause or subclause; additional annexes are lettered AA, BB, etc. A list of all parts of the IEC 61326 series, under the general title Electrical equipment for measurement, control and laboratory use, control and laboratory use EMC requirements can be fou
40、nd on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdr
41、awn, replaced by a revised edition, or amended. 61326-2-6 IEC:2012 5 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE EMC REQUIREMENTS Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equipment 1 Scope In addition to the scope of IEC 61326-1, this part of IEC 61326
42、 series specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment. 2 Normative references
43、 The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. Clause
44、 2 of IEC 61326-1:2012 applies, except as follows: Addition: IEC 61326-1:2012, Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements ISO 14971:2007, Medical devices Application of risk management to medical devices 3 Terms and definitions For
45、the purposes of this document, the terms and definitions given in IEC 61326-1 apply, except as follows. Addition: 3.101 in vitro diagnostic medical equipment instruments and apparatus intended for use in the diagnosis of disease or other conditions, including a determination of the state of health,
46、in order to cure, mitigate, treat, or prevent disease Note 1 to entry: Such instruments or apparatus are intended for use in the collection, preparation, and examination of specimens taken from the human body. 3.102 analyte constituent of a sample with a measurable property EXAMPLES In “mass of prot
47、ein in 24-hour urine”, “protein” is the analyte and “mass” is the property. In “concentration of glucose in plasma”, “glucose” is the analyte and “concentration” is the property. In both cases, the full phrase designates the measurand. 6 61326-2-6 IEC:2012 SOURCE: ISO 18113-1:2009, 3.3 4 General Cla
48、use 4 of IEC 61326-1:2012 applies, except as follows: Addition: 4.101 Electromagnetic environment of IVD medical equipment Similar to conventional medical electrical equipment, in-vitro diagnostic medical equipment is used in a wide variety of electromagnetic environments. IVD devices shall function
49、 properly and safely in home environments, as well as in typical healthcare environments (hospitals, clinics, doctors offices). This means that the device shall have a minimum level of immunity appropriate for these areas. Devices intended for use in other environments, such as in ambulances, aircraft, cars or helicopters, can require a higher level of immunity to ensure the safe and effective perfor
