DD-ISO-TS-10993-19-2006.pdf
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1、DRAFT FOR DEVELOPMENT DD ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials ICS 11.100.20 ? Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:30:56 GMT+00:00 200
2、6, Uncontrolled Copy, (c) BSI DD ISO/TS 10993-19:2006 This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 31 August 2006 BSI 2006 ISBN 0 580 49048 3 National foreword This Draft for Development reproduces verbatim ISO/TS 10993-19:2006. This
3、publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. A review of
4、 this Draft for Development will be carried out not later than 2 years after its publication. Notification of the start of the review period, with a request for the submission of comments from users of this Draft for Development, will be made in an announcement in the appropriate issue of Update Sta
5、ndards. According to the replies received, the responsible BSI Committee will judge whether the Draft for Development can be converted into a British Standard or what other action should be taken. Observations which it is felt should receive attention before the official call for comments will be we
6、lcomed. These should be sent to the Secretary of BSI Technical Committee CH194, Biological evaluation of medical devices, at British Standards House, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the t
7、ext. A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “Internat
8、ional Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Summary of pages This d
9、ocument comprises a front cover, an inside front cover, the ISO/TS title page, pages ii to vi, pages 1 to 15 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: Lon
10、don South Bank University, London South Bank University, Sun Dec 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO/TS 10993-19:2006(E) TECHNICAL SPECIFICATION ISO/TS 10993-19 First edition 2006-06-01 Biological evaluation of medical devices Part 19: Physico-chemical, morpho
11、logical and topographical characterization of materials valuation biologique des dispositifs mdicaux Partie 19: Caractrisations physicochimique, morphologique et topographique des matriaux DD ISO/TS 10993-19:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 1
12、3:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction. vi 1 Scope 1 2 Normative references1 3 Terms and definitions .1
13、4 Symbols and abbreviated terms 2 5 General principles2 6 Characterization procedure3 6.1 General3 6.2 Qualitative information4 6.3 Material equivalence4 6.4 Quantitative information .4 6.5 Quantitative assessment 4 7 Characterization parameters and methods.5 8 Reporting of data obtained.8 Annex A (
14、informative) Principles for judging material equivalency 9 Annex B (informative) Nanoparticles Special consideration in judging material equivalency and biological evaluation .10 Bibliography11 DD ISO/TS 10993-19:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec
15、 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv 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 technical committ
16、ees. 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 with the Int
17、ernational 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 2. The main task of technical committees is to prepare International Standards. Draft International
18、Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such docu
19、ments, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the
20、parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in
21、 order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or b
22、e withdrawn. 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/TS 10993-19 was prepared by Technical Committee ISO/TC 194, Biological evaluation of
23、 medical devices. ISO 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 genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for i
24、nteractions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 9: Framework for identification and quantification of potential degradation products DD ISO/TS 10993-19:2006 Licensed Copy: London Sou
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