ISO INTERNATIONAL STANDARD 9583 First edition 1993-10-15 Implants for surgery - Non-destructive testing Liquid penetrant inspection of metallic surgical implants Implants chirurgicaux - Essais non destructifs - Controle par ressuage des implants chirurgicaux métalliques (So Reference number ISO9583:1993(E) No reproduction or networking permitted without license from IHS Not for Resale ISO9583:1993(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through IsO represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. IsO collaborates closely with the International Electrotechnical Commission (lEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International a vote. ISO/TC 150, Implants for surgery, Sub-Committee SC 1, Materials. Annex A of this International Standard is for information only. C ISO1993 by any means, electronic or mechanical, including photocopying and microfilm, without per. mission in writing from the publisher. International Organization for Standardization Case Postale 56 · CH-1211 Geneve 20 · Switzerland Printed in Switzerland Copyright In No reproduction or networking permitted without license from IHS Not for Resale ISO 9583:1993(E) INTERNATIONALSTANDARD Implants for surgery -- Non-destructive testing Liquid penetrant inspection of metallic surgical implants Scope 3 Inspection method 1 This International Standard establishes a method for 3.1 Inspection condition detecting and evaluating imperfections revealed by liquid penetrant on the surfaces of metallic surgical The surfaces shall be cleaned in accordance with implants. Is0 3452:1984, subclauses 6.2, 6.3 and 10.2 so that they are free of any material which would interfere Guidanceon theacceptancelimits for imperfections with the penetration of the inspection fluid or would on metallic surgical implants in the raw and finally in itself retain the penetrant and result in false indi- treated and finished conditions is given in annex A. cations. 3.2 Procedure Normative references The liquid penetrant inspection of metallic surgical implants shall be performed in accordance with The following standards contain provisions which, IsO 3452 using the penetrant systems classified through reference in this text, constitute provisions of this International Standard. At the time of publi- therein. cation, the editions indicated were valid. All standards are subject to revision, and parties to agreements 3.3 Penetrant materials based on this International Standard are encouraged to investigate the possibility of applying the most re- 3.3.1 Sensitivity cent editions of the standards indicated below Members of IEC and ISO maintain registers of cur- According to type, stress category. material and rently valid International Standards. manufacturing stage of the implant, penetrant ma terial systems of normal, high or very high sensitivity IS0 3059:1974, Non-destructive testing Method shall be used. The sensitivity level shall be established for indirect assessment of black light sources. by the manufacturer or purchaser. IsO 3452:1984, Non-destructive testing - Penetrant 3.3.2Compatibility inspection - General principles. In accordance with ISO 3452:1984, clause 6, all ISO 3453:1984, Non-destructive testing Liquid penetrant materials shall be compatible with each penetrant inspection - Means of verification. other. ASTM D 95:1983, Test method for Water in Pet- roleum Products and Bituminous Materials by Distil- 4 Inspection level lation. Unless otherwise requested by the manufacturer or ASNT-SNT-TC-1A,1) Personnel qualification and certi- purchaser of the implant, the inspection shali be f