BS EN 62570-2015 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment《磁共振环境下医疗装置和其他物件的安全标记标准实施规程》.pdf

1、BSI Standards PublicationStandard practice for marking medical devices and other items for safety in the magnetic resonance environmentBS EN 62570:2015National forewordThis British Standard is the UK implementation of EN 62570:2015. It is identical to IEC 62570:2014.The UK participation in its prepa

2、ration was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the neces

3、sary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 61978 6ICS 11.040.50; 11.040.55Compliance with a British Standard cannot confer immunity fromlegal obligations.This British St

4、andard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 62570:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 62570 May 2015 ICS 11.040.50; 11.040.55 English

5、Version Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2014) Pratiques normalises relatives au marquage des appareils mdicaux et des lments de sret divers ddis aux environnements de rsonance magntique (IEC 62570:2014) Standar

6、dverfahren fr die Kennzeichnung medizinischer Gerte und anderer Gegenstnde zur Sicherheit in der Umgebung von Magnetresonanzeinrichtungen (IEC 62570:2014) This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which

7、 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 to any CENELEC member. This

8、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 the official versions. CENELE

9、C 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, Luxembourg, Malta, the Netherland

10、s, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre:

11、 Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 62570:2015 E BS EN 62570:2015EN 62570:2015 2 Foreword The text of document 62B/933/FDIS, future edition 1 of IEC 62570, prepared by SC 62B “Diag

12、nostic imaging equipment“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62570:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an ide

13、ntical national standard or by endorsement (dop) 2016-01-14 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC an

14、d/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 requirements of EU Directive(s). For the relationship with

15、 EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 62570:2014 was approved by CENELEC as a European Standard without any modification. BS EN 62570:2015EN 62570:2015 3 Annex ZA (normative) Normat

16、ive references to international publications with their corresponding 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 reference

17、s, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards list

18、ed in this annex is available here: www.cenelec.eu. Publication Year Title EN/HD Year ASTM F2052 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment - - ASTM F2119 - Standard Test Method for Evaluation of MR Image

19、 Artifacts from Passive Implants - - ASTM F2182 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging - - ASTM F2213 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magne

20、tic Resonance Environment - - IEC 60601-2-33 2010 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis EN 60601-2-33 2010 - - + corrigendum Oct. 2010 - - + A11 2011 ISO 14971 - Medical d

21、evices - Application of risk management to medical devices EN ISO 14971 - ISO/IEC Guide 51 - Safety aspects - Guidelines for their inclusion in standards - - ISO/TS 10974 - Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device - - BS EN 62570:2

22、015EN 62570:2015 4 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This 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 all relevant essential

23、requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied

24、to the products falling within the scope of this standard. BS EN 62570:20152 CONTENTS FOREWORD 3 1 Scope 5 2 Referenced Documents 5 3 Terminology . 6 4 Significance and Use . 7 5 Requirements for assessment of potential hazards caused by interactions of an item and the MR Environment 7 6 Methods of

25、Marking 7 7 Information Included in MR Marking . 8 8 Keywords . 10 APPENDIX 13 X1. RATIONALE . 13 BS EN 62570:20153 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT FOREWORD 1) The International

26、 Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fi

27、elds. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any I

28、EC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardiza

29、tion (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has represen

30、tation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international 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 ca

31、nnot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publicati

32、ons. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly 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, a

33、ccess to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification 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 i

34、ndividual experts and members of its technical committees and IEC National Committees for any personal injury, property 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 up

35、on, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in 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

36、 of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 62570, integrating the unmodified text of ASTM F2503 - 13, has been developed by subcommittee 62B: Diagnostic imaging equipment, o

37、f IEC technical committee 62: Medical equipment in medical practice, in collaboration with ASTM. The text of this standard is based on the following documents: FDIS Report on voting 62B/933/FDIS 62B/934/RVD Full information on the voting for the approval of this standard can be found in the report o

38、n voting indicated in the above table. 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 BS

39、EN 62570:20154 reconfirmed, withdrawn, replaced by a revised edition, or amended. IMPORTANT The “colour inside” logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print

40、this publication using a colour printer. BS EN 62570:2015F2503 - 13 5 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment1This standard is issued under the fixed designation F2503 - 13; the number immediately following the designation indica

41、tes the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon () indicates an editorial change since the last revision or reapproval. 1. Scope 1.1 This international standard applies to t

42、he practice of marking of items that might be used in the magnetic resonance (MR) environment. 1.2 The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking. 1.3 The standard specifies the permanent

43、 marking of items, which are used in an MR environment, by means of terms and icons. 1.4 MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice (see X1.5). 1.5 The values stated in SI units are to be regarded as standard. No o

44、ther units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of his standard to establish appropriate safety and health practices and determine the applicabilit

45、y of regulatory limitations prior to use. 2. Referenced Documents 2.1 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 referenced document (including any

46、amendments) applies. 2.2 ASTM Standards:2F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants F2182 Test Method for Measurement of Radio Frequ

47、ency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment 2.3 Other Standards: IEC 60601-2-33 Medical Electrical EquipmentPart 2-33: Particular Requireme

48、nts for the Safety of Magnetic Resonance Equipment for Medical Diagnosis4ISO 14971 Medical Devices Application of Risk Management to Medical Devices ISO/IEC Guide 51 Safety Aspects Guidelines for their Inclusion in Standards ISO TS 10974 Assessment of the Safety of Magnetic Resonance Imaging for Pat

49、ients with an Active Implantable Medical Device 1This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15 on Material Test Methods. Current edition approved Oct. 1, 2008. Published November 2008. Originally approved in 2005. Last previous edition approved in 2005 as F2503 05. DOI: 10.1520/F2503 - 08. 2For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at