ISO-10993-14-2001.pdf
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1、Reference number ISO 10993-14:2001(E) ISO 2001 INTERNATIONAL STANDARD ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics valuation biologique des dispositifs mdicaux Partie 14: Identification
2、 et quantification des produits de dgradation des cramiques Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:43:46 MDTNo reproduction or networking permitted without license fr
3、om IHS -,-,- ISO 10993-14:2001(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the e
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6、at the address given below. ISO 2001 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 be
7、low or ISOs 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.ch Web www.iso.ch Printed in Switzerland ii ISO 2001 All rights reserved Copyright International Organization for Standar
8、dization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:43:46 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10993-14:2001(E) ISO 2001 All rights reservediii ContentsPage Foreword.iv Introductionvi 1S
9、cope 1 2Normative references1 3Terms and definitions .2 4Test procedures.2 4.1Principle2 4.2Testing of dental devices2 4.3General testing techniques.3 4.4Extreme solution test 4 4.5Simulation solution test6 5Analysis of filtrate9 5.1General9 5.2Choice of chemicals or elements to be analysed.9 5.3Sen
10、sitivity of the analysis method.9 6Test report9 Bibliography11 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:43:46 MDTNo reproduction or networking permitted without license
11、 from IHS -,-,- ISO 10993-14:2001(E) iv ISO 2001 All rights reserved 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 technic
12、al 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. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely wi
13、th the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International 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
14、 member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 10993 may be the subject of patent rights. ISO shall not be held responsible
15、 for identifying any or all such patent rights. International Standard ISO 10993-14 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: Part 1: Evaluatio
16、n and testing 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 sterili
17、zation residuals Part 8: Selection and qualification of reference materials for biological tests 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: Sam
18、ple preparation and reference materials Part 13: Identification and quantification of degradation 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 an
19、d alloys Part 16: Toxicokinetic study design for degradation products and leachables Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:43:46 MDTNo reproduction or networking per
20、mitted without license from IHS -,-,- ISO 10993-14:2001(E) ISO 2001 All rights reservedv Part 17: Establishment of allowable limits for leachable substances using health-based risk assessment Part 18: Chemical characterization of materials Copyright International Organization for Standardization Pro
21、vided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:43:46 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10993-14:2001(E) vi ISO 2001 All rights reserved Introduction This part of ISO 10993 consists of two te
22、sts for the biological evaluation of medical devices: an extreme solution test and a simulation solution test. The extreme solution test is developed as a worst-case environment and the simulation test is developed as a very common environment. Degradation products covered by this part of ISO 10993
23、are formed primarily by dissolution in an aqueous environment. It is recognized that additional biological factors such as enzymes and proteins can alter the rate of degradation. Degradation by such outside factors is not addressed in this part of ISO 10993. It should be kept in mind that a ceramic
24、device might have extraneous chemical phases and/or elements in extremely minor amounts. Whilst these components might not be named in the original specification, they can often be suspected by the relationship that the material in question has to other materials and the expected history of the mate
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