1、BRITISH STANDARD BS 7731:1994 ISO 9584:1993 Method for Radiographic examination of cast metallic surgical implantsBS7731:1994 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublished under the authorityof the Standards Boardand comes
2、into effect on 15 February 1994 BSI 07-1999 The following BSI references relate to the work on this standard: Committee reference HCC/18 Draft for comment 92/54173 DC ISBN 0 580 22916 5 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Hea
3、lth Care Standards Policy Committee (HCC/-) to Technical Committee HCC/18, upon which the following bodies were represented: Association of British Health-care Industries British Forging Industry Association British Industrial Ceramic Manufacturers Association British Institute of Surgical Technolog
4、ists British Investment Casting Trade Association British Medical Association British Orthopaedic Association British Steel Industry British Surgical Trades Association Department of Health Department of Trade and Industry (Laboratory of the Government Chemist) Royal College of Surgeons of England R
5、oyal Veterinary College Scottish Office Sterilised Suture Manufacturers Association Surgical Dressings Manufacturers Association Amendments issued since publication Amd. No. Date CommentsBS7731:1994 BSI 07-1999 i Contents Page Committees responsible Inside front cover National foreword ii 1 Scope 1
6、2 Normative references 1 3 Definitions 1 4 Procedure 1 5 Inspection levels 1 6 Acceptance limits 1 7 Documentation 1 8 Personnel certification 1 Annex A (informative) Radiographic examination of cast metallic surgical implants Acceptance limits for internal imperfections 2 Table A.1 Recommended limi
7、ts for size, number, separation and (image) density for single imperfections and group of imperfections 2BS7731:1994 ii BSI 07-1999 National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with ISO9584:1993 Implants
8、for surgery Non-destructive testing Radiographic examination of cast metallic surgical implants, published by the International Organization for Standardization (ISO). Cross-references The Technical Committee has reviewed the provisions of ISO1027:1983, IS05579:1985, ISO5580:1985 and ASNT-SNT-TC-1A,
9、 to which normative reference is made in the text, and has decided that they are acceptable for use in conjunction with this standard. A related British Standard to ISO1027:1983 is BS3971:1980. ASNT publications are available from J.D. Lavender, 19 Windermere Road, Penistone, Sheffield S30 6HL. A Br
10、itish Standard does not purport to include all the necessary provisions of a contract. Users of 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 fr
11、ont cover, an inside front cover, pages i and ii, pages 1 and 2 and a back cover. 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.ISO 9584:1993(E) BSI 07-1999 1 1 Scope This Internat
12、ional Standard establishes a method for detecting and evaluating internal imperfections of cast metallic surgical implants. Guidance on the acceptance limits for internal imperfections in cast metallic surgical implants is given in Annex A. 2 Normative references The following standards contain prov
13、isions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the p
14、ossibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 1027:1983, Radiographic image quality indicators for non-destructive testing Principles and identification. ISO 5579:1985, Non-d
15、estructive testing Radiographic examination of metallic materials by X- and gamma rays Basic rules. ISO 5580:1985, Non-destructive testing Industrial radiographic illuminators Minimum requirements. ASNT-SNT-TC-1A, Personnel qualification and certification in non-destructive testing 1) . 3 Definition
16、s The terms used in this International Standard are defined inISO5576. 4 Procedure 4.1 Radiographic method The radiographic method shall be in accordance with the requirements inISO1027 and ISO5579. 4.2 Illumination of radiographs Radiographs shall be examined under illumination complying with the r
17、equirements of ISO5580. Radiographic examination of metallic surgical implant castings may create spurious indications resulting from grain diffraction patterns and actual imperfections. Radiographic techniques shall be used which ensure that differences between such diffraction patterns and actual
18、imperfections are distinguished. 4.3 Image quality For X-ray energies less than 500 kV, the quality level for radiography shall be either: at least 2 % (2-2T) in accordance with the method in ASTM E 142, or an equivalent image quality number (IQN) in accordance with ISO1027. For high energy X-rays (
19、greater than 500 kV), a (2-4T) image quality or an equivalent IQN in accordance with ISO1027 shall be satisfactory. 5 Inspection levels Unless otherwise requested by the manufacturer or purchaser of the implant, the inspection shall be100% of the lot. 6 Acceptance limits The product acceptance and r
20、ejection criteria for internal imperfections shall be established by written specifications. Recommended acceptance limits are given in Annex A. 7 Documentation 7.1 Radiographs The radiographs and their evaluations shall be documented so that they are traceable to the examined implants. Unless other
21、wise requested by the purchaser, the radiographs shall be supplied together with the implants. 7.2 Report A record of radiographic examination results shall be maintained. 8 Personnel certification The personnel performing radiographic examination in accordance with this International Standard shall
22、 be certified to level 2 as specified in ASNT-SNT-TC-1A or recognized national equivalents and shall be specifically trained for the product range of medical implants. 1) American Society for Non-destructive TestingISO 9584:1993(E) 2 BSI 07-1999 Annex A (informative) Radiographic examination of cast
23、 metallic surgical implants Acceptance limits for internal imperfections A.1 Recommended acceptance limits The manufacturers or purchasers acceptance and rejection criteria should describe type, size and separation of acceptable imperfections in relation to the inspection area. For this, the manufac
24、turer or purchaser should indicate on drawings the different inspection areas of the metallic surgical implants (seeA.2). According to the stress level in the inspection areas, the acceptance limits as given in Table A.1 are recommended. A.2 Inspection areas Table A.1 Recommended limits for size, nu
25、mber, separation and (image) density for singleimperfections and group of imperfections A B C D E To be indicated by the manufacturer or purchaser Type of imperfection a Maximum length b Minimum separation Maximum image density Maximum number cper 25 mm inspection area length d mm mm shallow medium
26、Single imperfection (voids, inclusions, less density) A B C D E 0,25 to 0,5 1 0 0 2 1 2 1 3 1 4 2 0,5 to 1 2 0 0 1 0 2 1 2 1 2 2 1 to 1,5 3 0 0 0 0 1 0 1 0 2 1 1,5 to 2 4 0 0 0 0 0 0 1 0 2 1 Group eof imperfections (porosity shrinkage) Maximum number per inspection area u 1,5 3 0 0 0 0 2 1 3 1 4 2 1
27、,5 to 3 6 0 0 0 0 1 0 1 0 2 1 3 to 5 10 0 0 0 0 0 0 1 0 2 1 a Linear imperfections (length : breadth 3 : 1) should not be accepted. b Imperfections 0,25 mm should be disregarded. c If larger imperfections are not present, smaller imperfections should be accepted up to the maximum number allowed for
28、all sizes of the inspection areas. In areas which are to be machined, the number of imperfections, imperfection size, intensity and separation are unlimited provided they are completely removed by the subsequent machining operation. d Any 25 mm by 25 mm surface area that exists in the zone designate
29、d. e For groups of imperfections, that is, single imperfections separated by less than twice the longest dimension of the longest imperfection, the maximum dimension should be the diameter in which all the single imperfections of the group are contained.blankBS 7731:1994 ISO 9584:1993 BSI 389 Chiswi
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