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1、BRITISH STANDARD BS 7731:1994 ISO 9584:1993 Method for Radiographic examination of cast metallic surgical implants Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:30:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7731:1994 This British Standard, having been
2、 prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes 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 9
3、2/54173 DC ISBN 0 580 22916 5 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/18, upon which the following bodies were represented: Association of British Health-c
4、are Industries British Forging Industry Association British Industrial Ceramic Manufacturers Association British Institute of Surgical Technologists British Investment Casting Trade Association British Medical Association British Orthopaedic Association British Steel Industry British Surgical Trades
5、 Association Department of Health Department of Trade and Industry (Laboratory of the Government Chemist) Royal College of Surgeons of England Royal Veterinary College Scottish Office Sterilised Suture Manufacturers Association Surgical Dressings Manufacturers Association Amendments issued since pub
6、lication Amd. No.DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:30:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7731:1994 BSI 07-1999i Contents Page Committees responsibleInside front cover National forewordii 1Scope1 2Normative references1
7、3Definitions1 4Procedure1 5Inspection levels1 6Acceptance limits1 7Documentation1 8Personnel certification1 Annex A (informative) Radiographic examination of cast metallic surgical implants Acceptance limits for internal imperfections2 Table A.1 Recommended limits for size, number, separation and (i
8、mage) density for single imperfections and group of imperfections2 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:30:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7731:1994 ii BSI 07-1999 National foreword This British Standard has been prepared under the
9、 direction of the Health Care Standards Policy Committee. It is identical with ISO 9584:1993 Implants for surgery Non-destructive testing Radiographic examination of cast metallic surgical implants, published by the International Organization for Standardization (ISO). Cross-references The Technical
10、 Committee has reviewed the provisions of ISO 1027:1983, IS0 5579:1985, ISO 5580:1985 and ASNT-SNT-TC-1A, 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 ISO 1027:1983 is BS 3971:1980.
11、 ASNT publications are available from J.D. Lavender, 19 Windermere Road, Penistone, Sheffield S30 6HL. A British 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 Standa
12、rd does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front 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 indi
13、cated in the amendment table on the inside front cover. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:30:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 9584:1993(E) BSI 07-19991 1 Scope This International Standard establishes a method for detecting and e
14、valuating 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 provisions which, through reference in this text, constitut
15、e 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 possibility of applying the most recent editions of the
16、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-destructive testing Radiographic examination of metallic
17、 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 testing1). 3 Definitions The terms used in this International Standard are defin
18、ed in ISO 5576. 4 Procedure 4.1 Radiographic method The radiographic method shall be in accordance with the requirements in ISO 1027 and ISO 5579. 4.2 Illumination of radiographs Radiographs shall be examined under illumination complying with the requirements of ISO 5580. Radiographic examination of
19、 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 imperfections are distinguished. 4.3 Image quality
20、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 ISO 1027. For high energy X-rays (greater than 500 kV), a (2-4T) image quality or an
21、 equivalent IQN in accordance with ISO 1027 shall be satisfactory. 5 Inspection levels Unless otherwise requested by the manufacturer or purchaser of the implant, the inspection shall be 100 % of the lot. 6 Acceptance limits The product acceptance and rejection criteria for internal imperfections sh
22、all 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 otherwise requested by the purchaser, the radiograph
23、s 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 be certified to level 2 as specified in ASNT-S
24、NT-TC-1A or recognized national equivalents and shall be specifically trained for the product range of medical implants. 1) American Society for Non-destructive Testing Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:30:17 GMT+00:00 2006, Uncontrolled Copy, (
25、c) BSI ISO 9584:1993(E) 2 BSI 07-1999 Annex A (informative) Radiographic examination of cast 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 sepa
26、ration of acceptable imperfections in relation to the inspection area. For this, the manufacturer or purchaser should indicate on drawings the different inspection areas of the metallic surgical implants (see A.2). According to the stress level in the inspection areas, the acceptance limits as given
27、 in Table A.1 are recommended. A.2 Inspection areas Table A.1 Recommended limits for size, number, separation and (image) density for single imperfections and group of imperfections A B C D E To be indicated by the manufacturer or purchaser Type of imperfectionaMaximum lengthb Minimum separation Max
28、imum image densityMaximum numberc per 25 mm inspection area lengthd mmmmshallowmedium Single imperfection (voids, inclusions, less density) ABCDE 0,25 to 0,51 0 0 2 1 2 1 3 1 4 2 0,5 to 12 0 0 1 0 2 1 2 1 2 2 1 to 1,53 0 0 0 0 1 0 1 0 2 1 1,5 to 24 0 0 0 0 0 0 1 0 2 1 Groupe of imperfections (porosi
29、ty shrinkage) Maximum number per inspection area u 1,53 0 0 0 0 2 1 3 1 4 2 1,5 to 36 0 0 0 0 1 0 1 0 2 1 3 to 510 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, sma
30、ller imperfections should be accepted up to the maximum number allowed for 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 ope
31、ration. d Any 25 mm by 25 mm surface area that exists in the zone designated. 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 imperfection
32、s of the group are contained. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:30:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:30:17 GMT+00:00 2006, Uncontrolled Co
33、py, (c) BSI BS 7731:1994 ISO 9584:1993 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Roy
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41、ude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade designations. If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained. If permission is granted, the terms may include royalty payments or a licensing agreement. Details and advice can be obtained from the Copyright Manager. Tel: 020 8996 7070. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:30:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
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