BS ISO 5834-2-2011 Implants for surgery Ultra-high-molecular-weight polyethylene Moulded forms《外科植入物 超高分子量聚乙烯 模塑型》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 5834-2:2011Implants for surgery Ultra-high-molecular-weightpolyethylenePart 2: Moulded formsBS ISO 5834-2:2011 BRITISH STANDARDNational forewordThis British Standard is th

2、e UK implementation of ISO 5834-2:2011. Itsupersedes BS ISO 5834-2:2006 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/1, Materials for surgical implants.A list of organizations represented on this committee can beobtained on request to its secr

3、etary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 70215 0ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was publish

4、ed under the authority of theStandards Policy and Strategy Committee on 31 August 2011.Amendments issued since publicationDate Text affectedBS ISO 5834-2:2011Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded formsImplants chirurgicaux Polythylne trs haute masse molculaire

5、 Partie 2: Produits sous forme moule ISO 2011Reference numberISO 5834-2:2011(E)Fourth edition2011-08-01ISO5834-2INTERNATIONAL STANDARDBS ISO 5834-2:2011ISO 5834-2:2011(E)COPYRIGHT PROTECTED DOCUMENT ISO 2011All rights reserved. Unless otherwise specified, no part of this publication may be reproduce

6、d or utilized in any form or by any means, electronic or mechanical, including 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 officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 1

7、1Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in Switzerlandii ISO 2011 All rights reservedBS ISO 5834-2:2011ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Inte

8、rnational 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 committee. International organizations, governmental and non-governmental, in liaison wi

9、th 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 accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical

10、 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 approval by at least 75 % of the member bodies casting a vote.Attention is drawn to t

11、he 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 Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials.This fourth edi

12、tion cancels and replaces the third edition, which has been technically revised.ISO 5834 consists of the following parts, under the 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: Oxidat

13、ion index measurement method Part 5: Morphology assessment methodISO 5834-2:2011(E) ISO 2011 All rights reserved iiiBS ISO 5834-2:2011BS ISO 5834-2:2011INTERNATIONAL STANDARD ISO 5834-2:2011(E)Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms1 ScopeThis part of ISO

14、5834 specifies the requirements and corresponding test methods for moulded forms, e.g. sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.This part of ISO 5834 is not applicable to direct-moulded (near net shape), irradiated o

15、r finished products or products manufactured from polyethylene blended with additives or by blending different forms of polyethylene.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies.

16、For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 527-1, Plastics Determination of tensile properties Part 1: General principlesISO 1183-1:1), Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, li

17、quid pyknometer method and titration methodISO 3451-1:2008, Plastics Determination of ash Part 1: General methodsISO 5834-1, Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder formISO 11542-2:1998, Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and ext

18、rusion materials Part 2: Preparation of test specimens and determination of properties3 ClassificationThe material moulded from Type 1, Type 2 or Type 3 powder as defined in ISO 5834-1 shall be classified as Type 1, Type 2 or Type 3 respectively.4 MaterialThe moulded material shall be made from UHMW

19、PE powder in accordance with the requirements of ISO 5834-1.5 Manufacturing requirementsThe moulded material supplied for each order shall be identified by lot numbers.NOTE “Lot” refers to the material for which testing has been carried out and for which discrete records are kept.The material shall

20、be subjected to a stress-relief annealing process as agreed by the purchaser and the vendor.1) To be published (revision of ISO 1183-1:2004). ISO 2011 All rights reserved 1BS ISO 5834-2:2011In the moulding process, no liquid or powdery release agents shall be used (such as silicon or talc-based rele

21、ase agent) in order to avoid contamination, migration and moulding defects.6 Requirements6.1 Physical propertiesWhen 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

22、of material.The physical properties shall be measured on material in the consolidated and annealed state before further processing. Subsequent manufacturing processes can influence the comparison of test results.6.2 Particulate matterWhen visually inspected using normal or corrected vision with no m

23、agnification, not more than ten particles shall be visible on the surface of a sample or samples prepared in accordance with 7.8.Table 1 Physical propertiesProperty UnitRequirement Type 1Requirement Type 2Requirement Type 3Test method according to subclauseDensity kg/m3927 to 944 927 to 944 927 to 9

24、44 7.2Ash, maximum mg/kg 150 150 300 7.3Tensile stress, y, at yield, minimumMPa 21 19 19 7.4Tensile stress, R, at break, minimumMPa 35 27 27 7.5Elongation at break, R, minimum% 300 300 250 7.6Double-notched impact strength, Charpy a, acN, minimumkJ/m2180 (126) b90 (73) 30 (25) 7.7 NOTE The minimum v

25、alues given in this table are for the mean of the results for the specimens tested. Individual test specimen results might be below this minimum.aEither the Charpy or Izod impact test specified in 7.7 may be performed. In cases of doubt or dispute, the test method specified in ISO 11542-2 (Charpy) s

26、hall be used as the reference method.bThe values in parentheses are determined in accordance with ASTM F648:2007 (Izod). 7 Test methodsCAUTION The UHMWPE powder and the semi-finished and finished products for this application are not equipped with light stabilizers and should therefore be protected

27、against the influence of ultraviolet radiation.7.1 Test conditionsUnless otherwise specified, the testing specified in 7.2 and 7.4 to 7.7 shall be conducted under standard conditions of (23 2) C after storage of the test specimen for at least 16 h under these conditions.7.2 DensityThe density shall

28、be measured by means of method A (immersion method) specified in ISO 1183-1, using at least three specimens. The mean of the results on the three test specimens shall not exceed the value given in Table 1.ISO 5834-2:2011(E)2 ISO 2011 All rights reservedBS ISO 5834-2:20117.3 AshThe ash shall be measu

29、red in accordance with ISO 3451-1:2008, method A, performing duplicate tests on each of two test specimens at (700 50) C. The mean of the results on the two test specimens shall be less than the value given in Table 1.7.4 Tensile stress at yieldThe tensile stress at yield, y, shall be determined by

30、the tensile test specified in ISO 527-1, using an extensometer to measure the strain and applying a test speed of (100 10) mm/min. At least five test specimens of thickness (1,5 0,5) mm shall be tested. The mean of the results on the five test specimens shall not be less than the values given in Tab

31、le 1.7.5 Tensile stress at breakThe tensile stress at break, R, shall be measured during the test described in 7.4. The mean of the results on the five test specimens shall not be less than the values given in Table 1.7.6 Elongation at breakThe elongation at break, R, shall be measured during the te

32、st described in 7.4. The mean of the results on the five test specimens shall not be less than the values given in Table 1.7.7 Notched impact strengthThe double-notched impact strength, acN, shall be determined by the impact test specified in either ISO 11542-2:1998, Annex B (Charpy) or ASTM F648:20

33、07 (Izod).In case of doubt or dispute, the test method specified in ISO 11542-2 shall be used as the reference method.7.8 Sample area for extraneous matterA total machined surface area of (500 103) mm2shall be taken from locations within the fabricated form. The area examined shall include both tran

34、sverse and longitudinal samples, or it may be produced by repeated sectioning through the thickness of the fabricated form.8 Identification markingEach item supplied shall be identified with at least a lot identification. A marking, which can also be a serial identification, with reference to the lo

35、t identification, may be repeated at intervals along the length of the item.9 Test certificateEach 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 certificate shall include the following

36、 information:a) reference to this part of ISO 5834, i.e. ISO 5834-2:2011;b) statement of material type, i.e. Type 1 or Type 2 or Type 3;c) lot number or serial number with reference to the lot number;d) number of items;e) test values in accordance with the appropriate clauses of this part of ISO 583

37、4;f) description of the UHMWPE annealing treatment as agreed by the purchaser and the vendor.ISO 5834-2:2011(E) ISO 2011 All rights reserved 3BS ISO 5834-2:201110 LabellingEach package of moulded material shall be clearly marked as agreed between the purchaser and vendor.ISO 5834-2:2011(E)4 ISO 2011

38、 All rights reservedBS ISO 5834-2:2011Bibliography1 ISO 11542-1, Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 1: Designation system and basis for specifications2 ASTM F648:2007, Standard Specification for Ultra-High-Molecular-Weight Polyethylene P

39、owder and Fabricated Form for Surgical ImplantsISO 5834-2:2011(E) ISO 2011 All rights reserved 5BS ISO 5834-2:2011ISO 5834-2:2011(E)ICS 11.040.40Price based on 5 pages ISO 2011 All rights reservedThis page deliberately left blankBSI is the independent national body responsible for preparing British

40、Standardsand other standards-related publications, information and services. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter.British Standards Institution (BSI)raising standards worldwideBSI Group Headquarters389 Chiswick High Road L

41、ondon W4 4AL UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 Standards are updated by amendment or revision. Users of British Stan-dards 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 serv-ices. We would be g

42、rateful if anyone finding an inaccuracy or ambiguity whileusing this British Standard would inform the Secretary of the technical com-mittee responsible, the identity of which can be found on the inside frontcover.Tel: +44 (0)20 8996 9001 Fax: +44 (0)20 8996 7001BSI offers Members an individual upda

43、ting service called PLUS which ensuresthat subscribers automatically receive the latest editions of standards.Tel: +44 (0)20 8996 7669 Fax: +44 (0)20 8996 7001Email: Buying standardsYou may buy PDF and hard copy versions of standards directly using acredit card from the BSI Shop on the website addi

44、tion all orders for BSI, international and foreign standards publicationscan be addressed to BSI Customer Services.Tel: +44 (0)20 8996 9001 Fax: +44 (0)20 8996 7001Email: In response to orders for international standards, it is BSI policy tosupply the BSI implementation of those that have been publi

45、shedas British Standards, unless otherwise requested.Information on standardsBSI provides a wide range of information on national, Europeanand international standards through its Knowledge Centre.Tel: +44 (0)20 8996 7004 Fax: +44 (0)20 8996 7005Email: Various BSI electronic information services are

46、also available whichgive details on all its products and services. Tel: +44 (0)20 8996 7111 Fax: +44 (0)20 8996 7048Email: BSI Subscribing Members are kept up to date with standardsdevelopments and receive substantial discounts on the purchase priceof standards. For details of these and other benefi

47、ts contact Membership Ad-ministration. Tel: +44 (0)20 8996 7002 Fax: +44 (0)20 8996 7001 Email: Information regarding online access to British Standards via BritishStandards Online can be found at information about BSI is available on the BSI website at www.bsi- subsists in all BSI publications. B

48、SI also holds the copyright,in the UK, of the publications of the international standardization bodies. Ex-cept as permitted under the Copyright, Designs and Patents Act 1988 no ex-tract may be reproduced, stored in a retrieval system or transmitted in anyform or by any means electronic, photocopying, recording or otherwise without prior written permission from BSI. This does not preclude the freeuse, in the course of implementing the standard of necessary details such assymbols, and size, type or grade designations. If these details