BS EN 61331-3-1999 Protective devices against diagnostic medical X-radiation - Protective clothing and protective devices for gonads《X射线医疗诊断保护装置 生殖腺防护装置和防护服装》.pdf

1、BRITISH STANDARD BS EN 61331-3:1999 IEC 61331-3: 1998 BS 7817-3: 1999 Protective devices against diagnostic medical X-radiation Part 3: Protective clothing and protective devices for gonads The European Standard EN61331-3:1999 has the status of a BritishStandard ICS 11.040.50; 13.280; 13.340.10BSEN6

2、1331-3:1999 This BritishStandard, having been prepared under the directionof the Health and Environment Sector Committee, was published under the authorityof the Standards Committee and comes intoeffecton 15May1999 BSI 03-2000 ISBN 0 580 32459 1 National foreword This BritishStandard is the English

3、language version of EN61331-3:1999. It is identical with IEC61331-3:1998. The UK participation in its preparation was entrusted to Technical Committee CH/73, Radiation protection dose control and utilization, which has the responsibility to: aid enquirers to understand the text; present to the respo

4、nsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on re

5、quest to its secretary. From 1 January1997, all IEC publications have the number60000 added to the old number. For instance, IEC27-1 has been renumbered as IEC60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both s

6、ystems. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The BritishStandards which implement these international or European publica

7、tions may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of

8、British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, theEN title page, pages2 to16 and a back cover.

9、This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsBSEN61331-3:1999 BSI 03-2000 i Contents Page National foreword Inside front

10、 cover Foreword 2 Text of EN 61331-3 5ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61331-3 January 1999 ICS 11.040.50 English version Protective devices against diagnostic medical X-radiation Part 3: Protective clothing and protective devices for gonads (IEC 61331-3:1998) Dispositifs

11、 de protection radiologique contre les rayonnements X pour diagnostic mdical Partie 3: Vtements et dispositifs de protection des gonades (CEI 61331-3:1998) Strahlenschutz in der medizinischen Rntgendiagnostik Teil 3: Schutzkleidung und Gonadenschutz (IEC 61331-3:1998) This European Standard was appr

12、oved by CENELEC on1999-01-01. 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 national standard without any alteration. Up-to-date lists and bibliographical references concerning such natio

13、nal 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 version in any other language made by translation under the responsibility of a CENELEC member into its own language

14、 and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain

15、, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1999 CENELEC All rights of exploitation

16、in any form and by any means reserved worldwide for CENELEC members. Ref.No.EN61331-3:1999EEN61331-3:1999 BSI 03-2000 2 Foreword The text of document 62B/347/FDIS, future edition1 of IEC61331-3, prepared by SC62B, Diagnostic imaging equipment, of IEC TC62, Electrical equipment in medical practice, w

17、as submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN61331-3 on1999-01-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex A and Ann

18、ex ZA are normative and Annex B is informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC61331-3:1998 was approved by CENELEC as a European Standard without any modification. latest date by which the ENhas to be implemented at national level by

19、 publication of an identical national standard or by endorsement (dop)1999-10-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow)2001-10-01EN61331-3:1999 BSI 03-2000 3 Contents Page Foreword 2 1 Scope and object 5 1.1 Scope 5 1.2 Object 5 2 Normative ref

20、erences 5 3 Terminology 5 3.1 Degree of requirements 5 3.2 Use of terms 5 3.3 Defined terms 5 4 General 6 4.1 ACCOMPANYING DOCUMENTS 6 4.2 Language of the ACCOMPANYING DOCUMENTS 6 4.3 General requirement on marking 6 4.4 Design 6 4.5 Materials 6 5 PROTECTIVE APRONS 6 5.1 Design 6 5.2 Materials 7 5.3

21、 Dimensions 7 5.4 Marking 7 5.5 Statement of compliance 8 6 PROTECTIVE GLOVES 8 6.1 Design 8 6.2 Materials 8 6.3 Dimensions 8 6.4 Marking 9 6.5 Statement of compliance 9 7 PROTECTIVE MITTENS 10 7.1 Design 10 7.2 Materials 10 7.3 Dimensions 10 7.4 Marking 10 7.5 Statement of compliance 11 8 PROTECTIV

22、E GONAD APRONS 11 8.1 Design 11 8.2 Materials 11 8.3 Dimensions 11 8.4 Marking 11 8.5 Statement of compliance 11 9 SCROTUM SHIELDS 12 9.1 Design 12 9.2 Materials 12 9.3 Dimensions 12 Page 9.4 Marking 12 9.5 Statement of compliance 12 10 OVARY SHIELDS 12 10.1 Design 12 10.2 Materials 13 10.3 Dimensio

23、ns 13 10.4 Marking 13 10.5 Statement of compliance 13 11 SHADOW SHIELDS 13 11.1 Design 13 11.2 Materials 13 11.3 Dimensions 13 11.4 Marking 13 11.5 Statement of compliance 14 Annex A (normative) Terminology Index of defined terms 15 Annex B (informative) Bibliography 16 Annex ZA (normative) Normativ

24、e references to internationalpublications with their correspondingEuropean publications 16 Figure 1 Inside dimensions of PROTECTIVE GLOVES 9 Figure 2 Inside minimum dimensions ofPROTECTIVE MITTENS 10 Table 1 Standard sizes of PROTECTIVE APRONS 7 Table 2 Standard sizes of PROTECTIVE GLOVES 8 Table 3

25、Standard sizes of PROTECTIVE GONAD APRON 114 blankEN61331-3:1999 BSI 03-2000 5 1 Scope and object 1.1 Scope This part of International Standard IEC61331 applies to PROTECTIVE DEVICES such as PROTECTIVE CLOTHING for the protection of persons against X-RADIATION up to150kV, during RADIOLOGICAL examina

26、tions and interventional procedures. NOTEPROTECTIVE DEVICES are not intended by themselves to provide complete protection of persons, but are used to reduce the dose to persons where other methods of protection against X-RADIATION are insufficient or not applicable. 1.2 Object This standard deals wi

27、th: general requirements on the ACCOMPANYING DOCUMENTS, and on design and materials used; standard sizes, particular design features, minimum ATTENUATION properties of materials, marking and standardized forms of statements of compliance with this standard. It covers PROTECTIVE CLOTHING mainly for t

28、he protection of the OPERATOR, such as: PROTECTIVE APRONS; PROTECTIVE GLOVES; PROTECTIVE MITTENS; and PROTECTIVE DEVICES for gonads for the protection of the PATIENT, such as: PROTECTIVE GONAD APRONS; SCROTUM SHIELDS; OVARY SHIELDS; SHADOW SHIELDS. The latter group of PROTECTIVE DEVICES is intended

29、to be used during RADIOLOGICAL examinations to minimize the effects of IRRADIATION on the reproductive organs particularly with regard to genetic damage. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this p

30、art of IEC61331. At the time of publication, the editions indicated were valid. All normative documents are subject to revision, and parties to agreements based on this part of IEC61331 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indi

31、cated below. Members of IEC and ISO maintain registers of currently valid International Standards. IEC 60788:1984, Medical radiology Terminology. IEC 61331-1:1994, Protective devices against diagnostic medical X-radiation Part1:Determination of attenuation properties of materials. 3 Terminology 3.1

32、Degree of requirements In this standard, certain terms which are not printed in SMALL CAPITALS have particular meanings, as follows: 3.2 Use of terms In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions in IEC60788, in this standard or in other IECpublicati

33、ons referenced in Annex A. NOTEAttention is drawn to the fact that, in the case that the concept addressed is not strongly confined to the definition given in one of the publications listed above, the corresponding term is printed in lower case letters. An index of defined terms used in this standar

34、d is given in Annex A. 3.3 Defined terms For the purpose of this part of IEC61331 the following additional definitions apply. 3.3.1 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 an OVARY SHIELD; see

35、rm-64-05 of IEC60788 3.3.2 SHADOW SHIELD PROTECTIVE DEVICE to intercept the RADIATION BEAM in the areas of the gonads, to be used when a SCROTUM SHIELD and an OVARY SHIELD cannot be used “shall” indicates a requirement that is mandatory for compliance; “should” indicates a strong recommendation that

36、 is not mandatory for compliance; “may” indicates a permitted manner of complying with a requirement or of avoiding the need to comply; “specified” is used to indicate definitive information stated by the MANUFACTURER in ACCOMPANYING DOCUMENTS or in other documentation relating to the equipment unde

37、r consideration, usually concerning its intended purpose, or the parameters or conditions associated with its use or with testing to determine compliance.EN61331-3:1999 6 BSI 03-2000 3.3.3 PROTECTIVE MITTEN PROTECTIVE GLOVE with open palm and separated thumb used where full perception of touch is es

38、sential 4 General 4.1 ACCOMPANYING DOCUMENTS PROTECTIVE DEVICES shall not be provided without ACCOMPANYING DOCUMENTS. The ACCOMPANYING DOCUMENTS shall contain information on the following: a) identity of the items of PROTECTIVE DEVICE(S) to which they apply, by reference to type or to individual ite

39、ms, as appropriate; b) description of all markings on the items, with explanation of their meanings; c) INSTRUCTIONS FOR USE, which shall contain: d) recommendations for storage when not in use; e) recommendations for methods and materials to be used for cleaning and disinfection; f) recommended met

40、hod and frequency of periodic inspection by the USER in order to verify the maintenance of ATTENUATION properties; g) particulars of compliance with this standard. Any information included in the ACCOMPANYING DOCUMENTS that is particularly intended to be read by the PATIENT, shall be repeated in a s

41、eparate part containing all such information. 4.2 Language of the ACCOMPANYING DOCUMENTS This standard contains no requirements concerning the language(s) in which the ACCOMPANYING DOCUMENTS provided are to be written. Attention is drawn to the fact that when the ACCOMPANYING DOCUMENTS are written i

42、n 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 carefully by an expert who, wherever possible, should be authorized by the MANUFACTURER to act in that capacity. The ACCOMPANYING DOCUMENTS

43、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 ACCOMPAN

44、YING DOCUMENTS is ensured. 4.4 Design 4.4.1 PROTECTIVE DEVICES for the protection of OPERATORS should be so designed that they can be put on and taken off without assistance. 4.4.2 PROTECTIVE DEVICES for the protection of the PATIENT shall be designed so that they can be easily applied, and they sho

45、uld be designed so that they can be properly placed and, where necessary, fixed by the PATIENTS themselves. 4.5 Materials 4.5.1 The materials effecting the ATTENUATION shall be homogeneously distributed and shall contain elements of high atomic number. 4.5.2 The ATTENUATION properties shall not vary

46、 under conditions of NORMAL USE. 4.5.3 All outer and inner accessible surfaces of PROTECTIVE DEVICES shall be suitable for cleaning and disinfection. 4.5.4 It shall not be possible to touch uncovered or uncoated surfaces of metallic lead or lead compounds. 5 PROTECTIVE APRONS NOTEPROTECTIVE APRONS a

47、re intended to be worn by persons who are present in the EXAMINATION ROOM during RADIOLOGICAL examinations with or without interventional procedures. They are intended primarily to protect the main part of the body of the OPERATOR. To protect the complete body, additional protective devices have to

48、be used, for example thyroid shields, protective eye glasses or helmets. For the purpose of this standard, four different categories of PROTECTIVE APRONS are defined: light PROTECTIVE APRONS; heavy PROTECTIVE APRONS; light closed PROTECTIVE APRONS; heavy closed PROTECTIVE APRONS. NOTELight PROTECTIV

49、E APRONS may be worn for example in the operating theatre and in the gypsum room, or if the SIGNIFICANT ZONE OF OCCUPANCY is protected against STRAY RADIATION by other PROTECTIVE DEVICES, for example fixed on the X-RAY EQUIPMENT. 5.1 Design PROTECTIVE APRONS shall consist of one or more layers of protective material and shall be designed to cover the front part of the body from the throat down to at least the knees, the entire breastbone and the shoulders. The width of the protective material on each shoulder sh