BS EN 61326-2-6-2013 Electrical equipment for measurement control and laboratory use EMC requirements Particular requirements In vitro diagnostic (IVD) medical equipment《测量、控制和实验室用.pdf

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1、BSI Standards PublicationElectrical equipment for measurement, control and laboratory use EMC requirementsPart 2-6: Particular requirements In vitro diagnostic (IVD) medical equipmentBS EN 61326-2-6:2013National forewordThis British Standard is the UK implementation of EN 61326-2-6:2013. It isidenti

2、cal to IEC 61326-2-6:2012. It supersedes BS EN 61326-2-6:2006, whichwill be withdrawn on 4 February 2016.The UK participation in its preparation was entrusted by TechnicalCommittee GEL/65, Measurement and control, to Subcommittee GEL/65/1,System considerations.A list of organizations represented on

3、this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2013Published by BSI Standards Limited 2013ISBN 978 0 580 70410 9ICS

4、17.220; 19.080; 25.040.40; 33.100Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2013.Amendments issued since publicationAmd. No. Date Text affectedBRITISH

5、 STANDARDBS EN 61326-2-6:2013EUROPEAN STANDARD EN 61326-2-6 NORME EUROPENNE EUROPISCHE NORM May 2013 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B

6、 - 1000 Brussels 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61326-2-6:2013 E ICS 17.220; 25.040.40; 33.100 Supersedes EN 61326-2-6:2006 English version Electrical equipment for measurement, control and laboratory use - E

7、MC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2012) 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) (CEI 6132

8、6-2-6:2012) Elektrische Mess-, Steuer-, Regel- und Laborgerte - EMV-Anforderungen - Teil 2-6: Besondere Anforderungen - Medizinische In-vitro-Diagnosegerte (IVD) (IEC 61326-2-6:2012) This European Standard was approved by CENELEC on 2013-02-04. CENELEC members are bound to comply with the CEN/CENELE

9、C Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or

10、to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as t

11、he official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxem

12、bourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 61326-2-6:2013EN 61326-2-6:2013 - 2 - Foreword The text of document 65A/631/FDIS, future edition 2 of IEC 61326-2-6, prepared by SC 65A, “System aspe

13、cts“, of IEC TC 65, “Industrial-process measurement, control and automation“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61326-2-6:2013. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an iden

14、tical national standard or by endorsement (dop) 2013-11-04 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2016-02-04 This document supersedes EN 61326-2-6:2006. EN 61326-2-6:2013 includes the following significant technical change with respect to

15、 EN 61326-2-6:2006: update of the document with respect to EN 61326-1:2013. EN 61326-2-6:2013 is to be used in conjunction with EN 61326-1:2013 and follows the same numbering of clauses, subclauses, tables and figures. When a particular subclause of EN 61326-1 is not mentioned in this part, that sub

16、clause applies as far as is reasonable. When this standard states “addition”, “modification” or “replacement”, the relevant text in EN 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

17、to those in EN 61326-1; unless notes are in a new subclause or involve notes in EN 61326-1, they are numbered starting from 101 including those in a replaced clause or subclause; additional annexes are lettered AA, BB, etc. Attention is drawn to the possibility that some of the elements of this docu

18、ment may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requir

19、ements of EU Directive(s). For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 61326-2-6:2012 was approved by CENELEC as a European Standard without any modification. In the offi

20、cial version, for Bibliography, the following note has to be added for the standard indicated: ISO 18113-1:2009 NOTE Harmonized as EN ISO 18113-1:2011 (not modified). BS EN 61326-2-6:2013EN 61326-2-6:2013 - 4 - Annex ZA (normative) Normative references to international publications with their corres

21、ponding European publications 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 an

22、y amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Addition to the Annex ZA of EN 61326-1:2013 Publication Year Title EN/HD Year IEC 61326-1 2012 Electrical equipment for measurement, control and la

23、boratory use - EMC requirements - Part 1: General requirements EN 61326-1 2013 ISO 14971 2007 Medical devices - Application of risk management to medical devices EN ISO 14971 2012 BS EN 61326-2-6:2013- 5 - EN 61326-2-6:2013 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives T

24、his European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers only the essential requirements in B.3.3 (only with regard to electromagnetic disturbances) and B.6.2 as given in Annex

25、 I of EU Directive 98/79/EC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. NOTE: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN 61326-

26、2-6:2013 2 61326-2-6 IEC:2012 CONTENTS 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 during testing . 6 5.3 Operation conditions of EUT during te

27、sting 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 Performance criteria 9 7 Emission requirements . 9 8 Test resu

28、lts 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 professional use 9 Annex A (normative) Immunity test requirements for

29、 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 BS EN 61326-2-6:201361326-2-6 IEC:2012 5 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE EMC REQUIREMENTS Par

30、t 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 series specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, takin

31、g into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references

32、, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. Clause 2 of IEC 61326-1:2012 applies, except as follows: Addition: IEC 61326-1:2012, Electrical equipment for measurement, control and laboratory use EMC requir

33、ements Part 1: General requirements ISO 14971:2007, Medical devices Application of risk management to medical devices 3 Terms and definitions For 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 equipm

34、ent instruments and apparatus intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, 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,

35、and examination of specimens taken from the human body. 3.102 analyte constituent of a sample with a measurable property EXAMPLES In “mass of protein in 24-hour urine”, “protein” is the analyte and “mass” is the property. In “concentration of glucose in plasma”, “glucose” is the analyte and “concent

36、ration” is the property. In both cases, the full phrase designates the measurand. BS EN 61326-2-6:2013 6 61326-2-6 IEC:2012 SOURCE: ISO 18113-1:2009, 3.3 4 General Clause 4 of IEC 61326-1:2012 applies, except as follows: Addition: 4.101 Electromagnetic environment of IVD medical equipment Similar to

37、 conventional medical electrical equipment, in-vitro diagnostic medical equipment is used in a wide variety of electromagnetic environments. IVD devices shall function properly and safely in home environments, as well as in typical healthcare environments (hospitals, clinics, doctors offices). This

38、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 performance of the device. 5 EMC tes

39、t plan 5.1 General Subclause 5.1 of IEC 61326-1:2012 applies. 5.2 Configuration of EUT during testing Subclause 5.2 of IEC 61326-1:2012 applies. 5.3 Operation conditions of EUT during testing Subclause 5.3 of IEC 61326-1:2012 applies, except as follows: Addition: 5.3.101 Operational conditions The d

40、evice shall be set to conditions specified by the manufacturer. When different input power modes are available (e.g. battery, a.c. options), the manufacturer shall specify these mode(s) of operation, which cover(s) the most severe condition in accordance with the product risk analysis. 5.4 Specifica

41、tion of functional performance Subclause 5.4 of IEC 61326-1:2012 applies. 5.5 Test description Subclause 5.5 of IEC 61326-1:2012 applies. BS EN 61326-2-6:201361326-2-6 IEC:2012 7 6 Immunity requirements 6.1 Conditions during the tests Subclause 6.1 of IEC 61326-1:2012 is replaced as follows. 6.1 Con

42、ditions during the tests The configuration and modes of operation during the tests shall be precisely noted in the test report. Tests shall be applied to the relevant ports in accordance with Table 101. The tests shall be conducted in accordance with the basic standards. The tests shall be carried o

43、ut one at a time. If additional methods are required, the method and rationale shall be documented. 6.2 Immunity test requirements Subclause 6.2 of IEC 61326-1:2012 and its title are replaced as follows. 6.2 Risk assessment and consideration of EMC immunity requirements Powerful electromagnetic emis

44、sion sources can lead to malfunctions in nearby medical equipment under certain circumstances. Different types of medical electrical equipment have different levels of risk with a malfunction. IVD medical equipment however is not intended to keep alive or resuscitate patients, so a malfunction would

45、 not directly cause the death or serious injury of a patient. Such a malfunction in IVD medical electrical equipment can result in an incorrect reading, which can in turn lead to a wrong therapeutic decision (misdiagnosis). For some analytes and in some circumstances, an incorrect result could resul

46、t in serious harm to the patient. In the case of larger IVD electrical equipment, electromagnetic disturbances can also cause malfunctions that pose a direct threat to the operator, for example through unexpected mechanical movements. The manufacturer shall perform a risk analysis and assessment acc

47、ording to ISO 14971 for guidance in assessing risk associated with direct hazards as well as ISO 14971:2007, Annex H for guidelines for assessing the risk to patients from incorrect IVD test results. NOTE As a rule, results from IVD medical equipment are checked for plausibility by medical personnel

48、 or followed-up by decisions of a healthcare professional. IVD medical equipment for self-testing by lay users are always provided with advice on action to be taken in case of indeterminate results. The users are urged to contact their medical practitioner first before making any decision of medical

49、 relevance. Risks associated with the use of IVD medical equipment are similar to risks associated with non-life-supporting medical equipment. Therefore the immunity test requirements given in following Table 101 are similar to the requirements for non-life-supporting medical equipment. BS EN 61326-2-6:2013 8 61326-2-6 IEC:2012 Table 101 Immunity requirements for IVD medical equipment Port Phenomenon EMC Basic Standard Test value Enclosure Electrostatic discharge (ESD) IEC 61000-4-2 2 kV and 4