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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 It supersedes BS ISO 5834-2:1998 which is withdrawn.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
25、m Type 1, Type 2 or Type 31) powder as defined in ISO 5834-1 shall be classified as Type 1, Type 2 or Type 3 respectively. 5 Material The moulded material shall be made from UHMWPE powder complying with the requirements of ISO 5834-1. 6 Manufacturing requirements The moulded material supplied for ea
26、ch order shall be identified by lot numbers. NOTE 1 “Lot” refers to the material for which testing has been carried out and for which discrete records are kept. NOTE 2 The material can be subjected to a stress-relief annealing process by agreement between vendor and purchaser. Subsequent transit and
27、 storage might re-introduce stresses. 7 Requirements 7.1 Physical properties When measured using the appropriate test method, as defined in Table 1, the physical properties of the moulded material shall conform to the relevant values given in Table 1 for each type of material. The physical propertie
28、s should be measured before the annealing process because different annealing processes can influence the comparison of test results. 7.2 Particulate matter When inspected using normal or corrected vision, not more than ten particles shall be visible on the surface of (a) sample(s) prepared in accor
29、dance with 8.8. 1) Type 3 polymer is no longer manufactured. However, in order to cover existing supplies held in stockpile, this Type 3 material is retained in this part of ISO 5834 until next revision. Licensed CopyChinese University of Hong Kong, 11/04/2009 08:54, Uncontrolled Copy, (c) BSI BS IS
30、O 5834-2:2006 ISO 5834-2:2006(E) ISO 2006 All rights reserved 3 Table 1 Physical properties Property Unit Requirement Type 1 Requirement Type 2 Requirement Type 3 a Test method according to subclause Density kg/m3 927 to 944 927 to 944 927 to 944 8.2 Ash b mg/kg u 150 u 150 u 300 8.3 Tensile stress,
31、 y, at yield c MPa W 21 W 19 W 19 8.4 Tensile stress, R, at break c MPa W 35 W 27 W 27 8.5 Elongation at break, R c % W 300 W 300 W 250 8.6 Double-notched impact strength, Charpy, aCN kJ/m2 W 180 W 90 W 30 8.7 Double-notched impact strength, lzod kJ/m2 W 126 W 73 W 25 8.7 a Type 3 polymer is no long
32、er manufactured. However, in order to cover existing supplies held in stockpile, this Type 3 material is retained in this part of ISO 5834 until next revision. b When determining the ash, it should be noted that in certain cases mould-release agents based on silicone are used in the production of th
33、e moulded forms. The residual mould-release agent on and in the moulded form will therefore be included in the determination of the ash. The upper limit of silica content (SiO2) from the ashing is considered to be 20 mg/kg. c The minimum values given in this table are for the mean of the results for
34、 the specimens tested. Individual test specimen results might be below this minimum. 8 Test methods CAUTION The UHMWPE powder, semi-finished and finished products for this application are not equipped with light stabilizers and should therefore be protected against the influence of ultraviolet radia
35、tion. 8.1 Test conditions Unless otherwise specified, the testing specified in 8.2 and 8.4 to 8.7 shall be conducted under standard conditions of (23 2) C and (50 5) % relative humidity after storage of the test specimen for at least 16 h under these conditions. 8.2 Density The density shall be meas
36、ured by means of method A (buoyancy procedure) specified in ISO 1183-1:2004 using at least three specimens. The mean of the results on the three test specimens shall not exceed the value given in Table 1. 8.3 Ash The ash shall be measured in accordance with ISO 3451-1:1997 method A, performing dupli
37、cate tests on each of two test specimens at (700 50) C. The mean of the results on the two test specimens shall not exceed the value given in Table 1. 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) 4 ISO 2006 All right
38、s reserved 8.4 Tensile stress at yield The tensile stress at yield, y, shall be determined by the tensile test specified in ISO 527-1 on at least five test specimens of thickness (1,5 0,5) mm using a test speed of (100 10) mm/min. The mean of the results on the five test specimens shall not be less
39、than the values quoted in Table 1. 8.5 Tensile stress at break The tensile stress at break, R, shall be measured during the test described in 8.4. The mean of the results on the five test specimens shall not be less than the values quoted in Table 1. 8.6 Elongation at break The elongation at break,
40、R, shall be measured during the test described in 8.4. The mean of the results on the five test specimens shall not be less than the values quoted in Table 1. 8.7 Notched impact strength The double-notched impact strength, aCN, shall be determined by the impact test specified in either Annex B of IS
41、O 11542-2:1998 (Charpy) or ASTM F648 (Izod). In cases of doubt or dispute the test method specified in ISO 11542-2 shall be used as the reference method. 8.8 Sample area for extraneous matter A total machined surface area of (500 103) mm2 shall be taken from locations within the fabricated form. The
42、 area examined shall include both transverse and longitudinal samples or may be produced by repeated sectioning through the thickness of fabricated form. 9 Identification marking Each item supplied shall be identified with an impressed identification number. NOTE The marking, which may also be a ser
43、ial number, with reference to the lot number, may be repeated at intervals along the length of the item. 10 Test certificate Each lot shall be supplied with a test certificate stating the results of the tests conducted and conformance with the requirements of this part of ISO 5834. The test certific
44、ate shall include the following information: a) the number of this International Standard, i.e. ISO 5834-2:2006; b) statement of material type, i.e. Type 1 or Type 2; c) lot number or serial number with reference to the lot number; d) number of items; e) test values according to the appropriate clau
45、ses of this part of ISO 5834; f) date(s) of test. 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 5 11 Labelling Each package of moulded material shall be clearly marked with at least the fo
46、llowing information: a) manufacturers name or trademark; b) description of contents; c) lot number; d) mass of the contents; e) the number of this International Standard, i.e. ISO 5834-2:2006. Licensed CopyChinese University of Hong Kong, 11/04/2009 08:54, Uncontrolled Copy, (c) BSI BS ISO 5834-2:20
47、06 ISO 5834-2:2006(E) ICS 11.040.40 Price based on 5 pages 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 This page has been intentionally left blank Licensed CopyChinese University of Hong Kong, 11/04/2009 0
48、8:54, Uncontrolled Copy, (c) BSI BS ISO 5834-2:2006 BSI Group Headquarters 389 Chiswick High Road, London, W4 4AL, UK Tel +44 (0)20 8996 9001 Fax +44 (0)20 8996 7001 standards BSI - British Standards Institution BSI is the independent national body responsible for preparing British Standards. It pr
49、esents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard