EN 61331-3-2014 en Protective devices against diagnostic medical X-radiation - Part 3 Protective clothing eyewear and protective patient shields.pdf

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1、BSI Standards PublicationProtective devices against diagnostic medical X-radiationPart 3: Protective clothing, eyewear and protective patient shieldsBS EN 61331-3:2014National forewordThis British Standard is the UK implementation of EN 61331-3:2014. It isidentical to IEC 61331-3:2014. It supersedes

2、 BS EN 61331-3:1999, which willbe withdrawn on 11 June 2017.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee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 o

3、btained 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 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 74635 2ICS 11.040.50; 13.280; 13.

4、340.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2014.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 61331-

5、3:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61331-3 August 2014 ICS Supersedes EN 61331-3:1999 English Version Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014) Dispositifs de protection r

6、adiologique contre les rayonnements X pour diagnostic mdical - Partie 3: Vtements et lunettes de protection radiologique, crans de protection pour le patient (CEI 61331-3:2014) Strahlenschutz in der medizinischen Rntgendiagnostik - Teil 3: Schutzkleidung, Augenschutz und Abschirmungen fr Patienten (

7、IEC 61331-3:2014) This European Standard was approved by CENELEC on 2014-06-11. 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 national standard without any alteration. Up-to-date lists an

8、d bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or 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

9、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. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Eston

10、ia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee f

11、or Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Me

12、mbers. Ref. No. EN 61331-3:2014 E BS EN 61331-3:2014EN 61331-3:2014 - 2 - Foreword The text of document 62B/938/FDIS, future edition 2 of IEC 61331-3, prepared by SC 62B, “Diagnostic imaging equipment“, of IEC TC 62, “Electrical equipment in medical practice “ was submitted to the IEC-CENELEC parall

13、el vote and approved by CENELEC as EN 61331-3:2014. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2015-04-24 latest date by which the national standards conflicting wit

14、h the document have to be withdrawn (dow) 2017-06-11 This document supersedes EN 61331-3:2002. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent

15、 rights. Endorsement notice The text of the International Standard IEC 61331-3:2014 was approved by CENELEC as a European Standard without any modification. BS EN 61331-3:2014- 3 - EN 61331-3:2014 Annex ZA (normative) Normative references to international publications with their corresponding Europe

16、an 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 any amendments)

17、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 listed in this annex is available here: www.cenelec.eu. Publication Year Title E

18、N/HD Year IEC 60601-1 AMD 1 2012 Medical electrical equipment_- Part_1: General requirements for basic safety and essential performance; Amendment_1 - - IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 2006 +EN 60601-1

19、:2006/corrigendum Mar. 2010 2010 +AC 2014 +A11 2011 IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 2008 +EN 60601-1-3:2008/corrigendum M

20、ar. 2010 2010 +A1 2013 +A1 2013 +AC 2014 IEC 61331-1 2014 Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials EN 61331-1 2014 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN 61331-3:2014 2 IEC 6

21、1331-3:2014 IEC 2014 CONTENTS 1 Scope 7 2 Normative references . 7 3 Terms and definitions. 8 4 General . 9 4.1 ACCOMPANYING DOCUMENTS . 9 4.2 Language of the ACCOMPANYING DOCUMENTS . 9 4.3 General requirement on marking 9 4.4 Design . 9 4.4.1 PROTECTIVE DEVICES for the protection of OPERATORS 9 4.4

22、.2 PROTECTIVE DEVICES for the protection of the PATIENT 10 4.5 Materials 10 4.5.1 Materials effecting ATTENUATION 10 4.5.2 Cleaning . 10 4.5.3 Touchable surfaces . 10 5 PROTECTIVE APRONS and THYROID COLLARS . 10 5.1 General 10 5.2 Design . 10 5.3 Materials 11 5.4 Dimensions 11 5.5 Marking 12 5.6 Sta

23、tement of compliance 12 6 PROTECTIVE GLOVES . 13 6.1 General 13 6.2 Design . 13 6.3 Materials 13 6.4 Dimensions 13 6.5 Marking 14 6.6 Statement of compliance 15 7 PROTECTIVE MITTENS . 15 7.1 General 15 7.2 Design . 15 7.3 Materials 15 7.4 Dimensions 15 7.5 Marking 16 7.6 Statement of compliance 16 8

24、 PROTECTIVE GONAD APRONS 17 8.1 General 17 8.2 Design . 17 8.3 Materials 17 8.4 Dimensions 17 8.5 Marking 17 8.6 Statement of compliance 18 BS EN 61331-3:2014IEC 61331-3:2014 IEC 2014 3 9 SCROTUM SHIELDS . 18 9.1 General 18 9.2 Design . 18 9.3 Materials 19 9.4 Dimensions 19 9.5 Marking 19 9.6 Statem

25、ent of compliance 19 10 OVARY SHIELDS . 19 10.1 General 19 10.2 Design . 20 10.3 Materials 20 10.4 Dimensions 20 10.5 Marking 20 10.6 Statement of compliance 20 11 SHADOW SHIELDS 21 11.1 General 21 11.2 Design . 21 11.3 Materials 21 11.4 Dimensions 21 11.5 Marking 21 11.6 Statement of compliance 21

26、12 PROTECTIVE APRONS FOR DENTAL USE 22 12.1 General 22 12.2 Design . 22 12.3 Materials 22 12.4 Dimensions 22 12.5 Marking 23 12.6 Statement of compliance 23 13 PROTECTIVE EYEWEAR . 23 13.1 General 23 13.2 Design . 23 13.3 Materials 24 13.4 Marking 24 13.5 Statement of compliance 24 Bibliography 25 I

27、ndex of defined terms used in this standard 26 Figure 1 Inside dimensions of PROTECTIVE GLOVES 14 Figure 2 Inside minimum dimensions of PROTECTIVE MITTENS 16 Table 1 Information and examples for marking PROTECTIVE APRONS and THYROID COLLARS 12 Table 2 Standard sizes of PROTECTIVE GLOVES 14 Table 3 I

28、nformation and examples for marking PROTECTIVE GLOVES 14 Table 4 Information and examples for marking PROTECTIVE MITTENS . 16 Table 5 Standard sizes of PROTECTIVE GONAD APRONS . 17 BS EN 61331-3:2014 4 IEC 61331-3:2014 IEC 2014 Table 6 Information and examples for marking PROTECTIVE GONAD APRONS . 1

29、8 Table 7 Information and examples for marking SCROTUM SHIELDS . 19 Table 8 Information and examples for marking OVARY SHIELDS . 20 Table 9 Information and examples for marking SHADOW SHIELDS 21 Table 10 Standard sizes of PROTECTIVE DENTAL APRONS 22 Table 11 Information and examples for marking PROT

30、ECTIVE APRONS 23 Table 12 Information and examples for marking PROTECTIVE EYEWEAR . 24 BS EN 61331-3:2014IEC 61331-3:2014 IEC 2014 7 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION Part 3: Protective clothing, eyewear and protective patient shields 1 Scope This part of IEC 61331 applies to

31、 PROTECTIVE DEVICES such as PROTECTIVE CLOTHING and EYEWEAR for the protection of persons against X-RADIATION up to 150 kV, during RADIOLOGICAL examinations and interventional procedures. NOTE PROTECTIVE DEVICES are not intended by themselves to provide complete protection of persons, but are used t

32、o reduce the dose to persons where other methods of protection against X-RADIATION are insufficient or not applicable. This standard deals with: general requirements on the ACCOMPANYING DOCUMENTS, on design and on materials used; sizing, particular design features, minimum ATTENUATION properties of

33、materials, marking and standardized forms of statements of compliance with this standard. It covers PROTECTIVE CLOTHING mainly for the protection of the OPERATOR, such as: PROTECTIVE APRONS; THYROID COLLARS; PROTECTIVE GLOVES; PROTECTIVE MITTENS; PROTECTIVE EYEWEAR; and PROTECTIVE DEVICES for the pr

34、otection of the PATIENT, such as: PROTECTIVE GONAD APRONS; SCROTUM SHIELDS; OVARY SHIELDS; SHADOW SHIELDS; PROTECTIVE APRONS FOR DENTAL USE. The latter group of PROTECTIVE DEVICES is intended to be used during RADIOLOGICAL examinations to minimize the effects of IRRADIATION on the reproductive organ

35、s particularly with regard to genetic damage. 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, only the edition cited applies. For undated references, the latest edition o

36、f the referenced document (including any amendments) applies. IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005/AMD 1:2012 BS EN 61331-3:2014 8 IEC 61331-3:2014 IEC 2014 IEC 60601-1-3:2008, Medical electrical equip

37、ment Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC 60601-1-3:2008/AMD1:2013 IEC/TR 60788:2004, Medical electrical equipment Glossary of defined terms IEC 61331-1:2014, Protective devices against d

38、iagnostic medical X-radiation Part 1: Determination of attenuation properties of materials EN 340:2003, Protective clothing General requirements EN 13402-3, Size designation of clothes Part 3: Measurements and intervals 3 Terms and definitions For the purposes of this document, the terms and definit

39、ions given in IEC/TR 60788:2004, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013 and the following apply. 3.1 AREA DENSITY Wsminimum mass per unit area of the protective material used to provide the required LEAD EQUIVALENT of the device, at all o

40、f the stated test values of X-RAY TUBE VOLTAGES Note 1 to entry: AREA DENSITY is expressed in SI units as kgm2. 3.2 PROTECTIVE APRON FOR DENTAL USE protective apron worn by the PATIENT to protect the region of the upper torso during RADIOLOGICAL dental procedures Note 1 to entry: Such an apron may h

41、ave an accompanying THYROID COLLAR, separate or attached. 3.3 PROTECTIVE EYEWEAR protective device made of transparent material to protect the eyes 3.4 PROTECTIVE GONAD APRON protective apron worn by the PATIENT to protect the region of the gonads as an alternative to the use of a SCROTUM SHIELD or

42、an OVARY SHIELD Note 1 to entry: See also rm-64-05 of IEC TR 60788:2004. 3.5 PROTECTIVE MITTEN protective glove with open palm and separated thumb used where full perception of touch is essential 3.6 SHADOW SHIELD protective device to intercept the radiation beam in the areas of the gonads Note 1 to

43、 entry: A SHADOW SHIELD is to be used when a SCROTUM SHIELD and an OVARY SHIELD cannot be used. BS EN 61331-3:2014IEC 61331-3:2014 IEC 2014 9 3.7 THYROID COLLAR protective device to cover the thyroid gland 4 General 4.1 ACCOMPANYING DOCUMENTS PROTECTIVE DEVICES shall not be provided without ACCOMPAN

44、YING DOCUMENTS. The ACCOMPANYING DOCUMENTS shall contain information on the following: a) identification of the items of PROTECTIVE DEVICE(S) to which they apply, by reference to type or to individual items, as appropriate; b) description of all markings on the items, with explanation of their meani

45、ngs; c) sizing information, in compliance with EN 340:2003 where appropriate, enabling garment label size information to be correlated with body size, where such information is not fully available on the garment label or marking itself; d) instructions for use, which shall contain: 1) recommendation

46、s for storage when not in use; 2) recommendations for methods and materials to be used for cleaning and disinfection; 3) recommended method and frequency of periodic inspection by the OPERATOR in order to verify the maintenance of ATTENUATION properties; 4) particulars of compliance with this standa

47、rd. Any information included in the ACCOMPANYING DOCUMENTS that is particularly intended to be read by the PATIENT, shall be repeated in a separate part containing all such information. 4.2 Language of the ACCOMPANYING DOCUMENTS This standard contains no requirements concerning the language(s) in wh

48、ich the ACCOMPANYING DOCUMENTS provided are to be written. Attention is drawn to the fact that when the ACCOMPANYING DOCUMENTS are written in a language other than that in which they were originally drafted and approved by the MANUFACTURER of the PROTECTIVE DEVICES, these documents shall be checked

49、carefully by an expert who, wherever possible, should be authorized by the MANUFACTURER to act in that capacity. The ACCOMPANYING DOCUMENTS shall state the language(s) in which they were originally drafted, approved or supplied by the MANUFACTURER and shall give a reference identifying at least one original version. 4.3 General requirement on marking PROTECTIVE DEVICES shall be marked so that their correlation to the pertaining ACCOMPANYING DOCUMENTS is ens