ISO-10993-16-1997.pdf
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1、I NTE R NATI ON AL STANDARD IS0 10993-1 6 First edition 1997-09-01 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables Evaluation biologique des dispositifs mdicaux - Partie 76: Conception des tudes toxicocintiques des produits de dg
2、radation et des substances relargables This material is reproduced from IS0 documents under International Organization for Standardization (ISO) Copyright License number IHSllCC11996. Not for resale. No part of these IS0 documents may be reproduced in any form, electronic retrieval system or otherwi
3、se, except as allowed in the copyright law of the country of use, or with the prior written consent of IS0 (Case postale 56,121 1 Geneva 20, Switzerland, Fax +41 22 734 10 79), IHS or the IS0 Licensors members. Reference number IS0 10993-1 6:1997(E) Copyright International Organization for Standardi
4、zation Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 20:31:23 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 10993-1 6:1997(E) Contents 1 Scope . 1 2 Normative reference . 1 3 Definitions . 1 4 Principl
5、es for design of toxicokinetic studies . 2 5 Guidance on test methods 3 5.1 General considerations . 3 5.2 Guidance on specific types of test 4 Annexes A Circumstances in which toxicokinetic studies shall be considered 7 B Bibliography . 8 0 IS0 1997 All rights resewed. Unless otherwise specified, n
6、o part o f 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 the publisher. International Organization for Standardization Case postale 56 CH-121 1 Genve 20 Switzerland Intern
7、et central iso.ch X.400 ech; adnet; p=iso; o=isocs; s=central Printed in Switzerland ii Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 20:31:23 MDTNo reproduction or networking
8、permitted without license from IHS -,-,- Q IS0 STD-IS0 10773-Lb-ENGL 1997 4851903 07Lb807 750 IS0 10993-1 6:1997(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standa
9、rds is normally carried out through IS0 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. International organizations, governmental and non-governmental, in liaison with ISO, also tak
10、e part in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) 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
11、Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard IS0 10993 was prepared by Technical Committee ISOflC 194, Biological evaluation of medical devices. IS0 10993 consists of the following parts, under the general title Biological evaluation of medi
12、cal devices: - Part 1: Evaluation 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 cytotoxicity: in vitro methods - Part 6: Tests for local effe
13、cts after implantation - Part 7: Ethylene oxide sterilization residuals - Part 9: Framework for the identification and quantification of potential degradation products rechnicai Report - Part 10: Tests for irritation and sensitization - Part 11: Tests for systemic toxicify - Part 12: Sample preparat
14、ion 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: Identification and quantification of degradation products from metals and alloys - Part 16: Tox
15、icokinetic study design for degradation products and leachables Future parts will deal with other relevant aspects of biological testing. Annex A forms an integral part of this part of IS0 10993. Annex 6 is for information only. iii Copyright International Organization for Standardization Provided b
16、y IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 20:31:23 MDTNo reproduction or networking permitted without license from IHS -,-,- STD-IS0 30973-Lb-ENGL 1997 4853903 0736808 b77 ISO 10993-16:1997(E) (8 IS0 Introduction This part of IS0 10993 pro
17、vides guidance and requirements on the design and performance of toxicokinetic studies. Toxicokinetics describes the absorption, distribution, metabolism and excretion of foreign compounds in the body with time. Essential to the evaluation of the safety of a medical device is consideration of the st
18、ability of the material(s) in vivo and the disposition of leachables and degradation products. Toxicokinetic studies may be of value in assessing the safety of materials used in the development of a medical device or in elucidating the mechanism of observed adverse reactions. The need for and extent
19、 of such studies should be carefully considered based on the nature and duration of contact of the device with the body. The potential hazard posed by a medical device may be attributed to the interactions of its components or their metabolites with the biological system. Medical devices may release
20、 leachables (e.g. residual catalysts, processing aids, residual monomers, fillers, antioxidants, plasticizers) and/or degradation products which migrate from the material and have the potential to cause adverse effects in the body. A considerable body of published literature exists on the use of tox
21、icokinetic methods to study the fate of chemicals in the body (see annex BI. The methodologies and techniques utilized in such studies form the basis of the guidance in this standard. A rationale for the use of this part of IS0 10993 is given in annex A. iv Copyright International Organization for S
22、tandardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 20:31:23 MDTNo reproduction or networking permitted without license from IHS -,-,- STD*ISO L0993-Lb-ENGL 1997 4851703 07Lb809 523 = INTERNATIONAL STANDARD Q IS0 IS0 10993-1
23、6:1997(E) Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables 1 Scope This part of IS0 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerat
24、ions for inclusion of toxicokinetic studies in the biological evaluation of medical devices. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this part of IS0 10993. At the time of publication, the edition indicated was
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