ISO-10993-12-2007.pdf
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1、 Reference number ISO 10993-12:2007(E) ISO 2007 INTERNATIONAL STANDARD ISO 10993-12 Third edition 2007-11-15 Corrected version 2008-02-15 Biological evaluation of medical devices Part 12: Sample preparation and reference materials valuation biologique des dispositifs mdicaux Partie 12: Prparation de
2、s chantillons et matriaux de rfrence Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 03:56:30 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10993-12:2007(E) PDF di
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6、OTECTED DOCUMENT ISO 2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs
7、 member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reserved Copyright International Organization for Standardization
8、Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 03:56:30 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10993-12:2007(E) ISO 2007 All rights reserved iii Contents Page Foreword iv Introduction. vi 1 Scope . 1 2 Normative
9、references. 1 3 Terms and definitions. 1 4 General requirements. 3 5 Reference materials 4 5.1 General. 4 5.2 Certification of RMs for biological safety testing 4 6 Use of RMs as experimental controls. 4 7 Test sample selection. 5 8 Test sample and RM preparation 5 9 Selection of representative port
10、ions from a device 5 10 Preparation of extracts of samples. 6 10.1 General. 6 10.2 Containers for extraction. 6 10.3 Extraction conditions and methods 6 10.4 Extraction conditions for hazard identification and risk estimation in the exaggerated-use condition 8 11 Records 9 Annex A (informative) Expe
11、rimental controls . 10 Annex B (informative) General principles on and practices of test sample preparation and sample selection 12 Annex C (informative) Principles of test sample extraction 14 Bibliography. 17 Copyright International Organization for Standardization Provided by IHS under license wi
12、th ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 03:56:30 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10993-12:2007(E) iv ISO 2007 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of natio
13、nal standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. Internati
14、onal organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rul
15、es given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at
16、least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10993-12 was prepared by Technical Committee ISO/
17、TC 194, Biological evaluation of medical devices. This third edition cancels and replaces the second edition (ISO 10993-12:2002), which has been technically revised. ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: Part 1: Evaluation and te
18、sting Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization r
19、esiduals Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 13: Identification and quantification of de
20、gradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloys Copyright International Organization for Standardization Provided by IHS under
21、license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 10/25/2008 03:56:30 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10993-12:2007(E) ISO 2007 All rights reserved v Part 16: Toxicokinetic study design for degradation products and leachables Part 17: Establ
22、ishment of allowable limits for leachable substances Part 18: Chemical characterization of materials Part 19: Physico-chemical, morphological and topographical characterization of materials TS Part 20: Principles and methods for immunotoxicology testing of medical devices TS Future parts will deal w
23、ith other relevant aspects of biological testing. This corrected version of ISO 10993-12 contains changes to definition 3.10 on page 3 and changes to footnote references in A.3 on page 11. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing
24、 Co/5910770001 Not for Resale, 10/25/2008 03:56:30 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10993-12:2007(E) vi ISO 2007 All rights reserved Introduction This part of ISO 10993 specifies methods of sample preparation and the selection of reference materials in th
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