BS ISO 5834-5-2005 Implants for surgery - Ultra-high molecular weight polyethylene - Morphology assessment method《外科植入物 超高分子量聚乙烯 形态学评价方法》.pdf

1、BRITISH STANDARD BS ISO 5834-5:2005 Implants for surgery Ultra-high molecular-weight polyethylene Part 5: Morphology assessment method ICS 11.040.40 BS ISO 5834-5:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 25 August 2005 BSI 25 Augu

2、st 2005 ISBN 0 580 46290 0 National foreword This British Standard reproduces verbatim ISO 5834-5:2005 and implements it as the UK national standard. The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/1, Materials (for su

3、rgical implants), which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue un

4、der the section entitled “International 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 ap

5、plication. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; mon

6、itor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii and iii, a blank page, pages 1 to 6, an inside back cover and a back cover. The BSI copyright notice display

7、ed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments Reference number ISO 5834-5:2005(E)INTERNATIONAL STANDARD ISO 5834-5 First edition 2005-06-01 Implants for surgery Ultra-high- molecular-weight polyethylene Part 5: Morphology

8、assessment method Implants chirurgicaux Polythylne trs haute masse molculaire Partie 5: Mthode dvaluation de la morphologie BS ISO 5834-5:2005ii BS ISO 5834-5:2005iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member

9、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 committee. International organizations, governmental

10、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 accordance with the rules given in the ISO/IEC Directive

11、s, 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 approval by at least 75 % of the member bodies c

12、asting 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 5834-5 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subco

13、mmittee SC 1, Materials. 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: Oxidation index measurement method Part 5: Morphology assess

14、ment method blank 1 Implants for surgery Ultra-high-molecular-weight polyethylene Part 5: Morphology assessment method 1 Scope This part of ISO 5834 specifies the test method for assessing the morphology of UHMWPE moulded forms, which are described in ISO 5834-2. It is not applicable to UHMWPE powde

15、r forms, which are described in ISO 5834-1. 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 ame

16、ndments) applies. 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, Plastics Ultr

17、a-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 2: Preparation of test specimens and determination of properties 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11542-1 and ISO 11542-2 and the following apply. 3.1

18、 Type A non-fused flake indication visible under the conditions described in 8.3.2 that has an essentially complete circumferential black boundary and a white centre See Figure 1. 3.2 Type B non-fused flake indication visible under the conditions described in 8.3.2 that has a partially circumferenti

19、al black boundary that appears to trace out 50 % to 99 % of a flakes perimeter See Figure 2. BS ISO 5834-5:2005BS ISO 5834-5:2005 2 3.3 morphology index MI material morphology quality determined as the ratio of the total number of Type A and Type B indications to the total surface area examined in c

20、m 2 , as shown in the following equation Type A + Type B MI = Area 3.4 lot material for which testing has been carried out and for which discrete records are kept 4 Classification, designation and coding The moulded material from Type 1, Type 2 or Type 3 1)powder as defined in ISO 5834-1 shall be cl

21、assified as Type 1, Type 2 or Type 3, respectively. 5 Material The moulded material which is the subject of the test shall be made from UHMWPE powder complying with the requirements of ISO 5834-1. 6 Manufacturing requirements The moulded material supplied for each order shall be identified by lot nu

22、mbers. The material may be subjected to a stress-relief annealing process by agreement between vendor and purchaser. Subsequent transit and storage may re-introduce stresses. 7 Requirements Performance requirements for this test method have not been established. 8 Test method CAUTION The UHMWPE powd

23、er, semi-finished and finished products for this application are not equipped with light stabilizers and should therefore be protected against UV influence. 8.1 General description This test method covers the determination of the morphology quality of moulded forms of ultra-high-molecular- weight po

24、lyethylene (UHMWPE). Well-consolidated UHMWPE has few or no regions of incompletely fused UHMWPE flake particles. This procedure is designed to evaluate the relative consolidation quality (morphology) of moulded forms of UHMWPE by measuring the number of incompletely fused UHMWPE particles. 1) Type

25、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 the next revision. 3 8.2 Test specimens Test specimens are approximately (100 50) m thick slices of the material. A minimum of five spe

26、cimens shall be evaluated for each representative sample (or lot) of material. Test specimens shall be collected from locations known to be most prone to consolidation difficulties; otherwise, at the approximate centre of the sample or as agreement between vender and purchaser. If multiple film samp

27、les are taken from the same piece they shall be taken from regions no closer than 0,5 mm apart. At least 2 cm 2of each test specimen shall be examined according to 8.3.2. 8.3 Preparing thin film specimens A minimum of five translucent film specimens approximately (100 50) m thick shall be prepared.

28、Films should be relatively uniform in thickness and essentially free of skives, tears, etc., commonly resulting from the use of dull cutting equipment. The thin films may be placed flat between two clean glass microscope slides for convenient microscopic examination. 8.3.1 Material sampling Test spe

29、cimens shall be collected as agreed upon between the purchaser and vendor. 8.3.2 Procedure Test specimens are evaluated by dark field optical microscopy at 40 magnification. Documentation shall be made of the number of Type A indications observed, the number of Type B indications observed, and the t

30、otal surface area examined for each test specimen. A maximum score of 100 shall be reported for the number of Type A or Type B indications in a single sample. The maximum morphology index of 100 reflects a practical limit to the number of defects an operator is willing to count. The maximum value of

31、 100 for morphology index should not be construed as a performance requirement for the morphology of UHMWPE. 8.4 Test certificate The certificate shall include the following for each material tested. a) The arithmetic average of the number Type A indications observed for the five specimens. b) The a

32、rithmetic average of the number Type B indications observed for the five specimens. c) Total surface area examined in cm 2 . d) The arithmetic average of the morphology index (3.3) for the five specimens. BS ISO 5834-5:20054 a) b) Figure 1 Representative Type A indications BS ISO 5834-5:2005 5a) b)

33、Figure 2 Representative Type B indications BS ISO 5834-5:20056 Bibliography 1 ISO 5834-2, Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms 2 ASTM F648, Standard specification for ultra-high-molecular-weight polyethylene powder and fabricated form for surgical impla

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