IEC 61326-2-6-2012 Electrical equipment for measurement control and laboratory use - EMC requirements - Part 2-6 Particular requirements - In vitro diagnostic (.pdf

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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

24、technical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specificat

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26、, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal dec

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28、rnational use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In o

29、rder to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be c

30、learly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certificatio

31、n bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, pr

32、operty damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited i

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