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1、a Date: 2 December 2008 Origin: International Latest date for receipt of comments: 28 February 2009 Project no.: 2007/03300 Responsible committee: CH/150/4 Bone and joint replacements Interested committees: Title: Draft BS ISO 14243-2 Implants for surgery - Wear of total knee-joint prostheses Part 2
2、: Methods of measurement Supersession information: If this document is published as a standard, the UK implementation of it will supersede BSISO14243-2 : 2000 and partially supersede. NONE If you are aware of a current national standard which may be affected, please notify the secretary (contact det
3、ails below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 28 February 2009. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No acknowledgement will norm
4、ally be sent. See overleaf for information on commenting. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for circulation within a nominating organization for briefing purposes. Electronic circulati
5、on is limited to dissemination by e-mail within such an organization by committee members. Further copies of this draft may be purchased from BSI Customer Services, Tel: +44(0) 20 8996 9001 or email . British, International and foreign standards are also available from BSI Customer Services. Informa
6、tion on the co-operating organizations represented on the committees referenced above may be obtained from the responsible committee secretary. Cross-references The British Standards which implement International or European publications referred to in this draft may be found via the British Standar
7、ds Online Service on the BSI web site http:/. Direct tel: 020 8996 7218 Responsible Committee Secretary: Mr R G Tanfield (BSI) E-mail: Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001 Form 36 Version 8.0 DPC: 08/30174988
8、 DC Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:41, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on international discussions in which the UK has taken an active part. Your comments on this draft are invited and will assist in the prepa
9、ration of the consequent standard. Comments submitted will be reviewed by the relevant BSI committee before sending the consensus UK vote and comments to the international secretariat, which will then decide appropriate action on the draft and the comments received. If the international standard is
10、approved, it is possible the text will be published as an identical British Standard. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. Submission The guidance given below is intended to ensure that all comments receive effici
11、ent and appropriate attention by the responsible BSI committee. Annotated drafts are not acceptable and will be rejected. All comments must be submitted, preferably electronically, to the Responsible Committee Secretary at the address given on the front cover. Comments should be compatible with Vers
12、ion 6.0 or Version 97 of Microsoft Word for Windows, if possible; otherwise comments in ASCII text format are acceptable. Any comments not submitted electronically should still adhere to these format requirements. All comments submitted should be presented as given in the example below. Further info
13、rmation on submitting comments and how to obtain a blank electronic version of a comment form are available from the BSI web site at: http:/ Template for comments and secretariat observations Date: xx/xx/200x Document: ISO/DIS xxxxx 1 2 (3) 4 5 (6) (7) MB Clause No./ Subclause No./ Annex (e.g. 3.1)
14、Paragraph/ Figure/Table/ Note (e.g. Table 1) Type of com- ment Comment (justification for change) by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1 Definition 1 ed Definition is ambiguous and needs clarifying. Amend to read . so that the mains connector to wh
15、ich no connection . 6.4 Paragraph 2 te The use of the UV photometer as an alternative cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer. Microsoft and MS-DOS are registered trademarks, and Windows is a trademark of Microsoft Corpora
16、tion. Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:41, Uncontrolled Copy, (c) BSI THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN A
17、DDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS. RECIPIENTS OF T
18、HIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION. DRAFT INTERNATIONAL STANDARD ISO/DIS 14243-2 International Organization for Standardization, 2008 INTERNATIONAL ORGANIZATION FOR STANDARDI
19、ZATION ORGANISATION INTERNATIONALE DE NORMALISATION ISO/TC 150/SC 4 Voting begins on: 2008-11-03 Secretariat: BSI Voting terminates on: 2009-04-03 Implants for surgery Wear of total knee-joint prostheses Part 2: Methods of measurement Implants chirurgicaux Usure des prothses totales de larticulation
20、 du genou Partie 2: Mthodes de mesure Revision of first edition (ISO 14243-2:2000) ICS 11.040.40 In accordance with the provisions of Council Resolution 15/1993 this document is circulated in the English language only. Conformment aux dispositions de la Rsolution du Conseil 15/1993, ce document est
21、distribu en version anglaise seulement. To expedite distribution, this document is circulated as received from the committee secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at publication stage. Pour acclrer la distribution, le prsent document est distrib
22、u tel quil est parvenu du secrtariat du comit. Le travail de rdaction et de composition de texte sera effectu au Secrtariat central de lISO au stade de publication. Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:41, Uncontrolled Copy, (c) BSI ISO/DIS 14243-2 ii ISO
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26、ddress given below. Copyright notice This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicable laws of the users country, neither this ISO draft nor any extract from it may be reproduced, stored in a retrieval system or transmitte
27、d in any form or by any means, electronic, photocopying, recording or otherwise, without prior written permission being secured. Requests for permission to reproduce should be addressed to either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case
28、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 Reproduction may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:4
29、1, Uncontrolled Copy, (c) BSI ISO/DIS 14243-2 ISO 2008 All rights reserved 1 Contents Page 1 Scope 1 2 Normative references1 3 Term and definition1 4 Gravimetric method.1 4.1 Principle1 4.2 Reagents and materials 1 4.3 Apparatus .2 4.4 Test and control specimens.2 4.5 Preparation of test and control
30、 specimens for gravimetric measurements (pre-soak conditioning)2 4.6 Procedure for gravimetric measurement 3 5 Test report3 Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:41, Uncontrolled Copy, (c) BSI 2 ISO 2008 All rights reserved Foreword ISO (the International
31、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 committees. Each member body interested in a subject for which a technical committee has been esta
32、blished 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 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardiza
33、tion. 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 Standards adopted by the technical committees are circulated to the member bodies for votin
34、g. 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such
35、patent rights. ISO 14243-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint replacement. This second edition cancels and replaces the first which has been technically revised. ISO 14243 consists of the following parts, under the general title Im
36、plants for surgery - Wear of total knee-joint prostheses Methods of measurement: Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test Part 2: Methods of measurement Part 3: Loading and displacement parameters for
37、wear-testing machines with displacement control and corresponding environmental conditions for test ISO/DIS 14243-2 Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:41, Uncontrolled Copy, (c) BSI DRAFT INTERNATIONAL STANDARD ISO/DIS 14243-2 ISO 2008 All rights reserv
38、ed 1 1 Scope This part of ISO 14242 specifies a method of assessment of wear of the tibial component of total knee-joint prostheses using the gravimetric technique for components tested in accordance with ISO 14242-1. 2 Normative references The following referenced documents are indispensable for th
39、e 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 14243-1, Implants for surgery Wear of total knee-joint prostheses Part 1: Loading and displacement param
40、eters for wear-testing machines with load control and corresponding environmental conditions for tests 3 Term and definition For the purposes of this part of ISO 14243, the following term and definition applies. 3.1 wear material loss from components of the prosthetic joint due to combined movement
41、and loading 4 Gravimetric method 4.1 Principle The test specimen is soaked in a lubricant. It is repeatedly removed from the lubricant, cleaned, dried and weighed until a steady rate of fluid sorption is established. The test specimen is assessed subsequently for wear by testing for loss in mass in
42、a knee-joint simulator. A loaded or unloaded, non-articulating control specimen submerged in the same lubricating fluid medium is intended to allow for fluid sorption and undergoes the same procedure for reference purposes. 4.2 Reagents and materials 4.2.1 Fluid test medium, in accordance with ISO 1
43、4243-1. 4.2.2 Control specimen, in accordance with ISO 14243-1. 4.2.3 Propan-2-ol. Implants for surgery Wear of total knee-joint prostheses Part 2: Methods of measurement Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:41, Uncontrolled Copy, (c) BSI 2 ISO 2008 All r
44、ights reserved 4.3 Apparatus 4.3.1 Balance, with an accuracy of 0,1 mg, of sufficient capacity for the mass of the test specimen. 4.3.2 Ultrasonic cleaner 4.3.3 Vacuum drying system, capable of achieving a vacuum of at least 13,33 Pa (100 milliTor). 4.3.4 Filtered inert-gas jet, e.g. nitrogen. 4.4 T
45、est and control specimens 4.4.1 Test specimen, conforming to ISO 14243-1. 4.4.2 Control specimen, conforming to ISO 14243-1. 4.5 Preparation of test and control specimens for gravimetric measurements (pre-soak conditioning) 4.5.1 Soak the test specimen and control specimen in the fluid test medium (
46、4.2.1) for 48 h 4 h. 4.5.2 Remove the test specimen and control specimen from the fluid test medium (4.2.1) and clean in the ultrasonic cleaner (4.3.2). A typical cleaning regime in the ultrasonic cleaner is as follows: a) vibrate for 10 min in deionized water; b) rinse in deionized water; c) vibrat
47、e for 10 min in a mixture of ultrasonic cleaning detergent at the concentration recommended by the detergent manufacturer; d) rinse in deionized water; e) vibrate for 10 min in deionized water; f) rinse in deionized water; g) vibrate for 3 min in deionized water; h) rinse in deionized water; i) dry
48、in a vacuum drying chamber (4.3.3). Care should be taken to avoid abrasion in the ultrasonic cleaner which could lead to change in mass. 4.5.3 Dry the test specimen and control specimen with a jet of inert gas (4.3.4). 4.5.4 Soak the test specimen and control specimen in propan-2-ol (4.2.3) for 5 mi
49、n 15 s. 4.5.5 Dry the test specimen and control specimen with a jet of filtered inert gas (4.3.4), then dry further in a vacuum of at least 13,3 Pa for at least 30 min. 4.5.6 Weigh the test specimen and control specimen on the balance twice in rotation within 90 min of removal from the vacuum. If the two readings per specimen do no