1、BRITISH STANDARD BS 7730:1994 ISO 9583:1993 Method for Liquid penetrant inspection of metallic surgical implants UDC 616-089.843:615.465:620.179.11BS7730:1994 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the author
2、ity of the Standards Board and comes into effect on 15February1994 BSI 03-1999 The following BSI references relate to the work on this standard: Committee reference HCC/18 Draft for comment 92/54262 DC ISBN 0 580 22915 7 Committees responsible for this British Standard The preparation of this Britis
3、h 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-care Industries British Forging Industry Association British Industrial Ceramic Manufacturers Association Brit
4、ish Institute of Surgical Technologists 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) Roy
5、al College of Surgeons of England Royal Veterinary College Scottish Office Sterilised Suture Manufacturers Association Surgical Dressings Manufacturers Association Amendments issued since publication Amd. No. Date CommentsBS7730:1994 BSI 03-1999 i Contents Page Committees responsible Inside front co
6、ver National foreword ii 1 Scope 1 2 Normative references 1 3 Inspection method 1 4 Inspection level 1 5 Acceptance limits 1 6 Inspection documentation 1 7 Penetrant materials control 1 8 Personnel certification 2 Annex A (informative) Liquid penetrant inspection of metallic surgical implants Accept
7、ance limits for surface imperfections 3 Table A.1 Recommended limits for size, number and separation forsingleandgroup of imperfections 3BS7730:1994 ii BSI 03-1999 National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee. It is ident
8、ical with ISO9583:1993 Implants for surgery Non-destructive testing Liquid penetrant inspection of metallic surgical implants, published by the International Organization for Standardization (ISO). Cross-references The Technical Committee has reviewed the provisions of ISO3059:1974, ISO3452:1984, IS
9、O3453:1984, ASTM D 95:1983 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. ASTM publications are available from Customer Services, Publications, BSI, Linford Wood, Milton Keynes MK14 6LE. ASNT p
10、ublications 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 Standard does
11、 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, pages1 to 3 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in
12、the amendment table on theinside front cover.ISO9583:1993(E) BSI 03-1999 1 1 Scope This International Standard establishes a method for detecting and evaluating imperfections revealed by liquid penetrant on the surfaces of metallic surgical implants. Guidance on the acceptance limits for imperfectio
13、ns on metallic surgical implants in the raw and finally treated and finished conditions is given inAnnex A. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the e
14、ditions 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 standards indicated below. Members of IEC and ISO maintain registers of curren
15、tly valid International Standards. ISO 3059:1974, Non-destructive testing Method for indirect assessment of black light sources. ISO 3452:1984, Non-destructive testing Penetrant inspection General principles. ISO 3453:1984, Non-destructive testing Liquid penetrant inspection Means of verification. A
16、STM D 95:1983, Test method for Water in Petroleum Products and Bituminous Materials by Distillation. ASNT-SNT-TC-1A, Personnel qualification and certification in non-destructive testing 1) . 3 Inspection method 3.1 Inspection condition The surfaces shall be cleaned in accordance with ISO 3452:1984,
17、subclauses6.2, 6.3 and10.2 so that they are free of any material which would interfere with the penetration of the inspection fluid or would in itself retain the penetrant and result in false indications. 3.2 Procedure The liquid penetrant inspection of metallic surgical implants shall be performed
18、in accordance with ISO3452 using the penetrant systems classified therein. 3.3 Penetrant materials 3.3.1 Sensitivity According to type, stress category, material and manufacturing stage of the implant, penetrant material systems of normal, high or very high sensitivity shall be used. The sensitivity
19、 level shall be established by the manufacturer or purchaser. 3.3.2 Compatibility In accordance with ISO3452:1984, clause6, all penetrant materials shall be compatible with each other. 4 Inspection level Unless otherwise requested by the manufacturer or purchaser of the implant, the inspection shall
20、 be100% of the lot. 5 Acceptance limits The product acceptance and rejection criteria shall be established by written specifications. Recommended acceptance limits are given in Annex A. 6 Inspection documentation The inspection results shall be documented so that they are traceable to the examined i
21、mplants. 7 Penetrant materials control NOTE 1The efficiency of penetrant materials deteriorates due to contamination and ageing. The following tests shall be conducted to evaluate usefulness of the materials. 7.1 Penetrants The density, visible dye intensity and fluorescent dye intensity shall be ch
22、ecked in accordance with ISO3453. 7.2 Emulsifiers 7.2.1 Water content The water content of oil-base emulsifiers shall be determined by ASTM D95 and shall not exceed10%. The frequency of testing shall be30 days for open containers and3months for closed containers. 1) American Society for Non-destruct
23、ive TestingISO9583:1993(E) 2 BSI 03-1999 7.2.2 Penetrant contamination The contamination of the emulsifier (oil-base and water-base) by the penetrant shall not exceed 10%. The concentration of the penetrant shall be checked by a refractometer. For each emulsifier and/or emulsifier concentration used
24、, a calibration for determining the refractometer correction shall be conducted. The frequency of testing shall be weekly or before use, whichever of the two alternatives is the more frequent. 7.3 Developer Dry and liquid developers shall be checked in accordance with ISO3453. 7.4 Ultraviolet radiat
25、ion lamp Ultraviolet radiation lamps used for fluorescent penetrant inspection shall be checked for ultraviolet radiation output in accordance with ISO3059. The frequency of testing shall be weekly. 8 Personnel certification The personnel performing liquid penetrant inspection in accordance with thi
26、s International Standard shall 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.ISO9583:1993(E) BSI 03-1999 3 Annex A (informative) Liquid penetrant inspection of metallic surgical i
27、mplants Acceptance limits for surface 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 manufacturer or purchaser sh
28、ould 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 inTable A.1 are recommended. A.2 Inspection areas Table A.1 Recommended limits for size, number and separation fo
29、r single and group of imperfections A To be indicated by the manufacturer or purchaser B C D E Type of imperfection a Maximum length b Minimum separation Maximum number cper 25 mm inspection area length d mm mm A B C D E Single imperfections e(voids, inclusions) 0,25 to 0,5 0,5 to 1 1 to 1,5 1,5 to
30、2 2 to 3 1 2 3 4 6 0 0 0 0 0 2 1 0 0 0 3 2 1 0 0 4 3 2 1 0 6 4 3 2 1 Maximum number per inspection area Group fof imperfections (porosity) # 2 2 to 4 4 to 6 3 6 10 0 0 0 0 0 0 2 1 0 3 2 1 6 3 2 a Linear imperfections (length:breadth 3:1) should not be accepted. b Imperfections 0,25mm should be disre
31、garded. c If larger imperfections are not present, smaller 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 and separation are unlimited provided they are complete
32、ly removed by the subsequent machining operation. d Any 25mm by 25mm of surface area that exists in the zone designated. e The imperfections which should be evaluated may be larger than the defect size on the surface depending on the depth of the imperfections. In order clearly to identify the imper
33、fections size the wipe-off technique using a volatile remover liquid may be adopted. f 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 imperf
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