BS-ISO-5834-2-2006.pdf
《BS-ISO-5834-2-2006.pdf》由会员分享,可在线阅读,更多相关《BS-ISO-5834-2-2006.pdf(14页珍藏版)》请在三一文库上搜索。
1、BS ISO 5834-2:2006 ICS 11.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Implants for surgery Ultra-high-molecular- weight polyethylene Part 2: Moulded forms Licensed CopyChinese University of Hong Kong, 11/04/2009 08:54, Uncontrolled Copy, (c) BSI Thi
2、s British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2009 BSI 2009 ISBN 978 0 580 53154 5 Amendments/corrigenda issued since publication DateComments BS ISO 5834-2:2006 National foreword This British Standard is the UK implementation of I
3、SO 5834-2:2006. It supersedes BS ISO 5834-2:1998 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants. A list of organizations represented on this committee can be obtained on request to its secretary. This publica
4、tion does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Licensed CopyChinese University of Hong Kong, 11/04/2009 08:54, Uncontrolled Copy, (c) BSI
5、 BS ISO 5834-2:2006 Reference number ISO 5834-2:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 5834-2 Third edition 2006-04-01 Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms Implants chirurgicaux Polythylne trs haute masse molculaire Partie 2: Produits sous forme mo
6、ule Licensed CopyChinese University of Hong Kong, 11/04/2009 08:54, Uncontrolled Copy, (c) BSI BS ISO 5834-2:2006 ISO 5834-2:2006(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 unl
7、ess the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademar
8、k of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. I
9、n the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2006 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, in
10、cluding photocopying and microfilm, without permission in writing from either ISO at the address below 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.org Web www.iso.org Publ
11、ished in Switzerland ii ISO 2006 All rights reserved Licensed CopyChinese University of Hong Kong, 11/04/2009 08:54, Uncontrolled Copy, (c) BSI BS ISO 5834-2:2006 ISO 5834-2:2006(E) ISO 2006 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide fede
12、ration of national 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 commi
13、ttee. International 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 accordan
14、ce with the rules 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
15、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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 5834-2 was prepared by Technical C
16、ommittee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. This third edition cancels and replaces the second edition (ISO 5834-2:1998), Table 1 of which has been technically revised. Further, type 3 polymer is no longer manufactured. ISO 5834 consists of the following parts, under the
17、 general title Implants for surgery Ultra-high-molecular- weight polyethylene: Part 1: Powder form Part 2: Moulded forms Part 3: Accelerated ageing methods Part 4: Oxidation index measurement method Part 5: Morphology assessment method Licensed CopyChinese University of Hong Kong, 11/04/2009 08:54,
18、Uncontrolled Copy, (c) BSI BS ISO 5834-2:2006 Licensed CopyChinese University of Hong Kong, 11/04/2009 08:54, Uncontrolled Copy, (c) BSI BS ISO 5834-2:2006 INTERNATIONAL STANDARD ISO 5834-2:2006(E) ISO 2006 All rights reserved 1 Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: M
19、oulded forms 1 Scope This part of ISO 5834 specifies the requirements and corresponding test methods for moulded forms (sheets, rods) made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. It does not apply to direct moulded (near net shape) or f
20、inished products. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 527-
21、1, Plastics Determination of tensile properties Part 1: General principles ISO 1183-1:2004, Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, liquid pyknometer method and titration method ISO 3451-1:1997, Plastics Determination of ash Part 1: General met
22、hods ISO 5834-1, Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form ISO 11542-1, Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 1: Designation system and basis for specifications ISO 11542-2:1998, Plastics Ultra-high-m
23、olecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 2: Preparation of test specimens and determination of properties ASTM F648, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants Licensed CopyChinese Universit
24、y of Hong Kong, 11/04/2009 08:54, Uncontrolled Copy, (c) BSI BS ISO 5834-2:2006 ISO 5834-2:2006(E) 2 ISO 2006 All rights reserved 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11542-1 and ISO 11542-2 apply. 4 Classification The material moulded fro
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- BS ISO 5834 2006
链接地址:https://www.31doc.com/p-3747579.html