STD.ISO 10993-S-ENGL 3999 MM 4851903 0786549 34h mm INTERNATIONAL Iso STANDARD 10993-5 Second edition 1999-05-15 EER rere ee Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity Evaluation biologique des dispositits médicaux — Partie 5: Essais concemant la cytotoxicité in vitro THis materiel Ie raproduced from ISO docurmants under tntemational Organieation for ‘Stendardizatlon iSO) Copyiight License Number INS/ICC/1996. Not for resale. No bart of thasa iSO documents may be reproduoed In eny form, electronic mulavel 27stom of othorwite. excapt ms allowed in the copyright law of the country of vse, ‘with the prio waitten comant of ISO (Case postal 66, 1211 Geneva 20, ‘Switzorand, Fax 441 22 734 10 73), IHS or the 190 Licensor’s mambers, Sa Reference number ISO 10993-5:1999(&)STD-ISO 3O999-S-ENGL 2999 MMH 4852503 078b544 242 ISO 10993-5:1999(E) Contents 1 Scope 2 Normative references......... 3 Terms and definitions 4 Semple preparation 5 Cell lines..... 6 Culture medium. 7 Preparation of ceil stock culture... © Iso 1900 ‘Al rights reserved. Untess otherwise specitiog, no pevt of this publication may be reproduced or ullized In any form or by arty means, electronic ‘or mechanikal, including photocopying and microfilm, without pacrission in waiting ftom the pubdishar. Snterational Organization for Standardization Case pootale 56 + CH-1211 Gendve 20 » Switzedand Intemet igo @ieo.ch Printed in SwitzortandSTD-ISO 10993-S-ENGL 1999 MM 4853593 6746545 125 me e1so ISO 10993-5:1999(E) Foreword 1SO (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 1SO technical committees. Each member body interested in a subject for which a tachnical committee, has been established has the Fight to be represented on that committes. Intemational organizations, governmental and non-govemmental, in liaison with ISO, also take part in the work. ISO collaborates closaly with the Intemational Electrotechnical ‘Commission (IEC) on all matters of electrotechnical standardization. Intemational Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Intemational Standard requires approval by at least 75 % of the member bodies casting a vote. Intemational Standard ISO 10993-5 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices, This second edition cancels and replaces the first edition (1SO 10993-5:1992), which has been technically revised. 1SO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: — Part 1: Evaluation and testing — Part 2: Animal weltare requirements — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity — Part 4: Selection of tests for interactions with blood — Part 5: Tests farin vitro cytotoxicity” — Part 6: Tests for local effects after implantation - — Part 7: Ethylene oxide sterilization residuals — Part 8: Guidance for reference materials — Part 9: Framework for the Identification and quantification of potential degradation products — Part 10: Tests for itation and sensitization — Part 11: Tests for systemic toxicity — Part 12: Sample preparation and reference materials — Part 13: Identification and quantification of degradation products from polymers — Part 14: Identification and quantification of degradation products from ceramics — Part 15: Identitication and quantification of degradation products from metals and alloys — Part 16: Toxicokinetic study design for degradation products and leachables — Part 17: Methods for establishment of allowable limits for leachable substances using health-based risk assessment — Part 18: Chemical characterization Future pasts will deal with other relevant aspects of biological testing.