BS-ISO-5834-4-2005.pdf
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1、BRITISH STANDARD BS ISO 5834-4:2005 Implants for surgery Ultra-high molecular weight polyethylene Part 4: Oxidation index measurement method ICS 11.040.40 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 5834-4:2005 This British Stan
2、dard was published under the authority of the Standards Policy and Strategy Committee on 28 October 2005 BSI 28 October 2005 ISBN 0 580 46381 8 National foreword This British Standard reproduces verbatim ISO 5834-4:2005 and implements it as the UK national standard. The UK participation in its prepa
3、ration was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/1, Materials (for surgical 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 S
4、tandards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publica
5、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 does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international
6、/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor 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,
7、pages ii to iv, pages 1 to 7 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:56 GMT+00:00 2006, Uncontrolled Copy,
8、 (c) BSI Reference number ISO 5834-4:2005(E) INTERNATIONAL STANDARD ISO 5834-4 First edition 2005-05-01 Implants for surgery Ultra-high molecular weight polyethylene Part 4: Oxidation index measurement method Implants chirurgicaux Polythylne trs haute masse molculaire Partie 4: Mthode de mesurage de
9、 lindice doxydation BS ISO 5834-4:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Foreword ISO (the International Organiza
10、tion 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 established
11、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 standardization. In
12、ternational 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 voting. Publi
13、cation 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 patent r
14、ights. ISO 5834-4 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee 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: Acc
15、elerated ageing methods Part 4: Oxidation index measurement method Part 5: Morphology assessment method BS ISO 5834-4:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Introduction This part of ISO 5834 describes a method for the measu
16、rement of the relative extent of oxidation present in ultra-high molecular weight polyethylene (UHMWPE) intended for use in surgical implants. The material is analysed by infrared spectroscopy. The intensity of the carbonyl absorptions (C=O) centred near 1 720 cm1 is related to the amount of chemica
17、lly bound oxygen present in the material. Other forms of chemically bound oxygen (R1OR2, R1OOR2, ROH, etc.) are not detected by this method. Although this method might give the investigator a means to compare the relative extent of carbonyl oxidation present in various UHMWPE samples, it is recogniz
18、ed that other forms of chemically bound oxygen can be important contributors to characteristics of these materials. The applicability of the infrared method has been demonstrated by many literature reports. This particular method, using the intensity (area) of the C-H absorption centred near 1 370 c
19、m1 to normalize for the samples thickness, has been validated by an interlaboratory study (ILS). BS ISO 5834-4:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Implants for surgery Ultra-high molecular weight polyethylene Part 4: Oxida
20、tion index measurement method 1 Scope This part of ISO 5834 specifies a method for the measurement of the relative extent of oxidation present in ultra-high molecular weight polyethylene (UHMWPE). It is applicable to ultra-high molecular weight polyethylene (UHMWPE) intended for use in surgical impl
21、ants. 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 5834-2, Implants
22、 for surgery Ultra-high molecular weight polyethylene Part 2: Moulded forms 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 Ultra-high-molecular-weight polyethylene
23、 (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 aperture size La length and width o
24、f a rectangular aperture, or the diameter of a circular aperture used by an infrared spectrometer to make spectral measurements 3.2 bulk oxidation index Iox,b sample mean of the oxidation indices collected over a range of about 1,5 mm near the centre of the samples oxidation index profile NOTE Typic
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