ISO-10993-15-2000.pdf
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1、INTERNATIONAL STANDARD IS0 10993-1 5 First edition 2000-12-01 Corrected and reprinted 2001-04-01 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys valuation biologique des dispositifs mdicaux - Partie 15: Identificati
2、on et quantification des produits de dgradation issus des mtaux et alliages Reference number IS0 10993-15:2000(E) 0 IS0 2000 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 01:34
3、:39 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 10993-1 5:2000(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 emb
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6、lem relating to it is found, please inform the Central Secretariat at the address given below. o 1s02000 , 4 1 1 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 mi
7、crofilm. without permission in writing from either IC0 at the address below or ISOs member body in the country of the requester. IS0 copyright office Case postale 56 CH-I21 1 Geneva 20 Tel. + 41 22 749 O1 11 Fax +41227490947 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland II O IS0 2000
8、- All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 01:34:39 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 10993-1 5:2000(E) Con
9、tents Page Foreword . iv Introduction vi 1 2 3 4 4.1 4.2 5 5.1 5.2 5.3 6 6.1 6.2 6.3 6.4 6.5 7 7.1 7.2 7.3 8 9 Scope 1 Normative references 1 Terms and definitions . 2 Degradation test methods 2 General 2 Prerequisites 3 Reagent and sample preparation . 3 Sample documentation . 3 Test solution (elec
10、trolyte) . 3 Preparation of test samples 3 Electrochemical tests 4 Apparatus . 4 Sample preparation . 4 Test conditions 5 Potentiodynamic measurements . 5 Potentiostatic measurements . 5 Immersion test . 5 Apparatus . 5 Sample preparation . 7 Immersion test procedure . 7 Ana lysis 8 Test report 8 An
11、nex A (informative) Schematic diagram of the electrochemical measuring circuit . 9 Annex B (informative) Schematic drawing of an electrolytic cell 10 Annex C (informative) Examples of alternative electrolytes for the electrochemical tests . 11 Bibliography 12 O is0 2000 . All rights reserved . . ._
12、. 111 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 01:34:39 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 10993-1 5:2000(E) Foreword IS0 (the I
13、nternational Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committees. Each member body interested in a subject for which a technical committee
14、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. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnica
15、l standardization. International Standards are drafted in accordance with the rules given in the ISOAEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting Publication as an International Standard requires approval by a
16、t least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of IS0 10993 may be the subject of patent rights. IS0 shall not be held responsible for identifying any or all such patent rights. International Standard IS0 10993-1 5 was p
17、repared by Technical Committee ISOnC 194, Biological evaluation of medical devices. IS0 10993 consists of the following parts, under the general title Biological evaluation of medical devices: - Part 1: Evaluation and testing - Part 2: Animal welfare requirements - Part 3: Tests for genotoxicify, ca
18、rcinogenicity 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 residuals - Part 8: Selection and qualification of reference material
19、s for biological tests - Part 9: Framework for identification and quantification of potential degradation products - Part 1 O: Tests for irritation and delayed-type hypersensitiviy - Part 11: Tests for systemic toxicity - Part 12: Sample preparation and reference materials - Part 13: Identification
20、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 and alloys - Part 16: Toxicokinetic study design for degradati
21、on products and leachables I iv 0 IS0 2000 -All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 01:34:39 MDTNo reproduction or networking permitted without licens
22、e from IHS -,-,- IS0 10993-1 5:2000(E) - Part 17: Establishment of allowable limits for leachable substances using health-based risk assessment - Part 18: Chemical characterization of materials Future parts will deal with other relevant aspects of biological testing. Annexes A, B and C of this part
23、of IS0 10993 are for information only. O IS0 2000 - All rights reserved V Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 01:34:39 MDTNo reproduction or networking permitted with
24、out license from IHS -,-,- IS0 10993-1 5:2000(E) Introduction One of the potential health hazards resulting from medical devices may be due to the interactions of their electrochemically-induced degradation products with the biological system. Therefore, the evaluation of potential degradation produ
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- ISO 10993 15 2000
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