1、BRITISH STANDARD BS EN 61326-2-6:2006Electrical equipmentfor measurement,control and laboratoryuse EMCrequirements Part 2-6: Particular requirements In vitro diagnostic (IVD) medicalequipmentICS 11.100.10; 33.100.01g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g5
2、4g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Incorporating corrigendum September 2007BS EN 61326-2-6:2006This British Standard waspublished under the authorityof the Standards Policy andStrategy Committee on 30 June 2006National f
3、orewordidentical with IEC 61326-2-6:2005, incorporating corrigendum September 2007. Together with BS EN 61326-1:2006, BS EN 61326-2-1:2006, BS EN GEL/65, Measurement and control, to subcommittee GEL/65/1, Systems considerations.A list of organizations represented on this subcommittee can be obtained
4、 on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments/corrigenda issued since publicationDate
5、Comments28 February 2010 Implementation of IEC corrigendum September 2007. interruptions, column: Test value)This British Standard is the UK implementation of EN 61326-2-6:2006. It is The UK participation in its preparation was entrusted by Technical Committee Modified entry in Table 1 (row: AC powe
6、r Voltage - BSI 2010ISBN 978 0 580 67025 161326-2-2:2006, BS EN 61326-2-3:2006, BS EN 61326-2-4:2006, BS EN 61326-2-5:2006, BS EN 61326-3-1:2008 and BS EN 61326-3-2:2008, it supersedes BS EN 61326:1998 which is withdrawn.EUROPEAN STANDARD EN 61326-2-6 NORME EUROPENNE EUROPISCHE NORM May 2006 CENELEC
7、 European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwi
8、de for CENELEC members. Ref. No. EN 61326-2-6:2006 E ICS 25.040.40; 33.100 Supersedes EN 61326:1997 + A1:1998 + A2:2001 + A3:2003English version Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equip
9、ment (IEC 61326-2-6:2005) 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 61326-2-6:2005) Elektrische Mess-, Steuer-, Regel- und Laborgerte EMV-Anforderungen Teil 2-6: Besondere
10、 Anforderungen Medizinische In-vitro-Diagnosegerte (IVD) (IEC 61326-2-6:2005) This European Standard was approved by CENELEC on 2005-12-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a n
11、ational standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A versio
12、n in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech Rep
13、ublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Foreword The text of document 65A/455/FDIS, fu
14、ture edition 1 of IEC 61326-2-6, prepared by SC 65A, System aspects, of IEC TC 65, Industrial-process measurement and control, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 61326-2-6 on 2005-12-01. The EN 61326 series supersedes EN 61326:1997 + corrigendum Septembe
15、r 1998 + A1:1998 + A2:2001 + A3:2003. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2006-12-01 latest date by which the national standards conflicting with the EN have to be
16、 withdrawn (dow) 2009-02-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 98/79/EC. See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. . _ Endorse
17、ment notice The text of the International Standard IEC 61326-2-6:2005 was approved by CENELEC as a European Standard without any modification. _ BS EN 61326-2-6:2006ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE EMC REQUIREMENTS Part 2-6: Particular requirements In vitro diagnostic
18、 (IVD) medical equipment 1 Scope In addition to the scope of International Standard IEC 61326-1, this part specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific
19、 aspects of this electrical equipment and their electromagnetic environment. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the refer
20、enced document (including any amendments) applies. IEC 60050-161:1990, International Electrotechnical Vocabulary (IEV) Part 161: Electro-magnetic compatibility IEC 61326-1:2005, Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements ISO 14971:
21、2000, 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 and IEC 60050(161) as well as the following apply. 3.101 in vitro diagnostic medical equipment instruments and apparatus i
22、ntended 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. Such instruments or apparatus are intended for use in the collection, preparation, and examination of specimens taken from the hum
23、an body. 4 General IEC 61326-1 applies, except as follows: BS EN 61326-2-6:2006Addition: 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. I
24、VD devices shall function 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
25、 as in ambulances, aircraft, cars or helicopters, may require a higher level of immunity to ensure the safe and effective performance of the device. 5 EMC test plan 5.1 General IEC 61326-1 applies. 5.2 Configuration of EUT during testing 5.2.1 General IEC 61326-1 applies. 5.2.2 Composition of EUT IE
26、C 61326-1 applies. 5.2.3 Assembly of EUT IEC 61326-1 applies. 5.2.4 I/O ports IEC 61326-1 applies. 5.2.5 Auxiliary equipment IEC 61326-1 applies. 5.2.6 Cabling and earthing (grounding) IEC 61326-1 applies. 5.3 Operation conditions of EUT during testing IEC 61326-1 applies, except as follows: Additio
27、n: 5.3.101 Operational conditions The device shall be set to conditions specified by the manufacturer. BS EN 61326-2-6:2006When 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
28、in accordance with the product risk analysis. 5.4 Specification of performance criteria IEC 61326-1 applies. 5.5 Test description IEC 61326-1 applies. 6 Immunity requirements 6.1 Conditions during the tests IEC 61326-1 applies, except as follows: The configuration and modes of operation during the t
29、ests shall be precisely noted in the test report. Tests shall be applied to the relevant ports in accordance with Table 1. The tests shall be conducted in accordance with the basic IEC 61000 series of standards. The tests shall be carried out one at a time. If additional methods are required, the me
30、thod and rationale shall be documented. 6.2 Immunity test requirements Subclause 6.2 of IEC 61326-1 is replaced by the following: 6.2.101 Risk assessment and consideration of EMC immunity requirements Powerful electromagnetic emission sources can lead to malfunctions in nearby medical equipment unde
31、r 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 not directly cause the death or serious injury of a patient. Such a m
32、alfunction in IVD medical electrical equipment may 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 result in serious harm to the patient. In the case of larger IVD electrical
33、 equipment, electromagnetic disturbances may also cause malfunctions that pose a direct threat to the operator, for example through unexpected mechanical movements. Refer to ISO 14971 for guidance in assessing risk associated with direct hazards and ISO 14971, Annex H for guidelines for assessing th
34、e risk to patients from incorrect IVD test results. NOTE As a rule, results from IVD medical equipment are checked for plausibility by medical personnel or followed-up by decisions of a healthcare professional. IVD medical equipment for self-testing by lay users are always provided with advice on ac
35、tion to be taken in case of indeterminate results. The users are urged to contact their medical practitioner first before making any decision of medical relevance. Risks associated with the use of IVD medical equipment are similar to risks associated with non-life-supporting medical equipment. There
36、fore the immunity test requirements given in following Table 1 are similar to the requirements for non-life-supporting medical equipment. BS EN 61326-2-6:2006Table 1 Minimum in vitro diagnostic (IVD) medical equipment immunity requirements Port Phenomenon EMC Basic Standard Test value Electrostatic
37、discharge (ESD) IEC 61000-4-2 2, 4, 8 kV air and 2, 4 kV contact Radiated E-field IEC 61000-4-3 3 V/m, 80 MHz to 2,0 GHz, 80 % AM Enclosure Rated power frequency magnetic fielda) IEC 61000-4-8 3 A/m, 50 and 60 Hz Voltage dipsd)IEC 61000-4-11 1 cycle 0 %; 5/6 cycles 40 %; 25/30 cycles 70 % Voltage in
38、terruptionsd)IEC 61000-4-11 Burst IEC 61000-4-4 1 kV (5/50 ns, 5 kHz) Surge IEC 61000-4-5 2 kV line to ground /1 kV line to line AC power Conducted RF IEC 61000-4-6 3 V, 150 kHz to 80 MHz, 80 % AM Burst IEC 61000-4-4 1 kV (5/50 ns, 5 kHz) Surge IEC 61000-4-5 2 kV line to ground /1 kV line to line DC
39、 power c)Conducted RF IEC 61000-4-6 3 V, 150 kHz to 80 MHz, 80 % AM Burst IEC 61000-4-4 0.5 kV (5/50 ns, 5 kHz) Surge IEC 61000-4-5 None I/O signals b)Conducted RF IEC 61000-4-6 3 V, 150 kHz to 80 MHz, 80 % AM Burst IEC 61000-4-4 1 kV (5/50 ns, 5 kHz) Surge IEC 61000-4-5 None I/O signals connected t
40、o mains Conducted RF IEC 61000-4-6 3 V, 150 kHz to 80 MHz, 80 % AM a) Test applied to only potentially magnetically sensitive equipment. CRT display interference is allowed above 1A/m. b) Only in case of lines 3m. c) Not applicable to input ports intended for connection to a battery or a rechargeabl
41、e battery which should be removed or disconnected from the apparatus for recharging. Apparatus with a d.c. power input port intended for use with an a.c. - d.c. power adaptor shall be tested on the a.c. power input of the a.c.- d.c. power adaptor specified by the manufacturer or, where none is so sp
42、ecified, using a typical a.c. - d.c. power adaptor. The test is applicable to d.c. power input ports intended to be connected permanently to long distance lines. d) “5/6 cycles“ means “5 cycles for 50 Hz test“ and “6 cycles for 60 Hz test”. Performance criteria shall be determined in relation to the
43、 electromagnetic phenomena by taking into account EUT operating modes that may affect data results and EUT operating modes that may affect sample processing and user interface. Applicable immunity phenomena from Table 1 shall be applied for each EUT operating mode. The EUT may show performance crite
44、ria A, B or C as a result of the application of the test, but shall not impair the performance characteristics necessary to maintain the residual risk within acceptable limits. Refer to ISO 14971 for guidelines for evaluation of residual risk acceptability. The performance criteria shall be included
45、 in the test report. Less than 5 % during 250/300 cycles BS EN 61326-2-6:20066.3 Random aspects IEC 61326-1 applies. 6.4 Performance criteria IEC 61326-1 applies. 7 Emission requirements IEC 61326-1 applies. 8 Test results and test report IEC 61326-1 applies 9 Instructions for use Clause 9 of IEC 61
46、326-1 is replaced as follows: Replacement: 9.101 Requirements for the IVD equipment instruction for use The following information shall be in the instructions for use that accompany the IVD equipment. NOTE 1 It is the manufacturers responsibility to provide equipment electromagnetic compatibility in
47、formation to the customer or user. NOTE 2 It is the users responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the device will perform as intended. 9.102 Instructions for in vitro diagnostic equipment for self-testing The instructio
48、n for use shall include the following preventive warnings with regard to EMC, e.g. a) ”Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets etc.) may cause damaging static discharges that may cause erroneous results.” b) ”Do not use
49、this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the proper operation.” 9.103 Instructions for in vitro diagnostic equipment for professional use. The instruction for use shall include the following information. a) A statement that the IVD equipment complies with the emission and immunity requirements described in this part of the IEC 61326 series. b) If emission compliance is Class A, state the warning: “This equipment has been designed and tested to CI
