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1、BRITISH STANDARD BS ISO 5834-1:2005 Implants for surgery Ultra-high- molecular-weight polyethylene Part 1: Powder form ICS 11.040.40 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 5834-1:2005 This British Standard was published und
2、er the authority of the Standards Policy and Strategy Committee on 10 November 2005 BSI 10 November 2005 ISBN 0 580 46289 7 National foreword This British Standard reproduces verbatim ISO 5834-1:2005 and implements it as the UK national standard. It supersedes BS ISO 5834-1:1998 which is withdrawn.
3、The UK participation in its preparation 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 secretar
4、y. Cross-references The British Standards 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 Briti
5、sh Standards Online. This publication 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
6、 to the responsible international/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
7、front cover, the ISO title page, pages ii and iii, a blank page, pages 1 to 4, an inside back cover 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
8、sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 5834-1:2005(E) INTERNATIONAL STANDARD ISO 5834-1 Third edition 2005-06-01 Implants for surgery Ultra-high- molecular-weight polyethylene Part 1: Powder form Implants chirurgicaux Polythylne trs haute
9、 masse molculaire Partie 1: Produits sous forme de poudre BS ISO 5834-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO
10、 5834-1:2005 iii Foreword ISO (the International 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 subj
11、ect 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 with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IE
12、C) 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 committees is to prepare International Standards. Draft International Standards adopted by the technical committ
13、ees 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 the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be
14、held responsible for identifying any or all such patent rights. ISO 5834-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. This third edition cancels and replaces the second edition (ISO 5834-1:1998), which has been technically revised. ISO 5834 co
15、nsists 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 assessment method Licensed Copy: sheffield
16、un sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form 1 Scope This part of
17、 ISO 5834 specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. It is not applicable to finished products. 2 Normative references The following refer
18、enced 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 1628-3, Plastics Determination of the viscosity of polymers in d
19、ilute solution using capillary viscometers Part 3: Polyethylenes and polypropylenes ISO 3451-1, Plastics Determination of ash Part 1: General methods ISO 11542-1, Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 1: Designation system and basis for spe
20、cifications ISO 11542-2, Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 2: Preparation of test specimens and determination of properties DIN 53474, Testing of plastics, rubber and elastomers Determination of the chlorine content (Wickbold- combustio
21、n) 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, designation and coding The material shall be classified as Type 1, Type 2 or Type 3 as defined by the flow properties given in Clause 6 and the ash/tr
22、ace element contents given in 7.1. BS ISO 5834-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 5 Manufacturing requirements The material shall consist of a homopolymer prepared by the polymerization of ethylene. The powdered materia
23、l 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. 6 Flow properties Flow properties shall be determined by measuring either elongation stress or viscosity number. When measur
24、ed using the appropriate test method, as defined in Table 1, the minimum value of either the elongational stress or the viscosity number shall exceed the relevant value given in Table 1 for each type of material. Table 1 Flow properties Minimum values Property Units Type 1 Types 2 and 3 Test method
25、according to subclause Elongational stress MPa 0,2 0,42 8.1 Viscosity number ml/g 2,000 3,200 8.2 NOTE Compliance with either of the above test requirements indicates satisfactory polymer molecular mass. 7 Limits of contamination 7.1 Ash and trace elements When measured using the appropriate test me
26、thod, as defined in Table 2, the amounts of ash, titanium, aluminium, calcium and chlorine shall not exceed the relevant value given in Table 2 for each type of material. Table 2 Maximum ash and trace element content Maximum quantity permitted mg/kg Element Type 1 Type 2 Type 3a Test method accordin
27、g to subclause Ash 125 125 300 8.3 Titanium 40 40 150 8.4 Calcium 5 5 50 8.4 Chlorine 30 30 90 8.4 Aluminium 20 20 100 8.4 a 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 the n
28、ext revision. 7.2 Particulate matter When measured using the test method given in 8.5, there shall be no more than three particles of contaminant in Type 1 or Type 2 materials and not more than 25 particles of contaminant in Type 3 materials (see Footnote to Table 2), per (300 20) g tested. BS ISO 5
29、834-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 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
30、 the influence of ultraviolet radiation. 8.1 Elongational stress The elongational stress shall be determined in accordance with ISO 11542-2. 8.2 Viscosity number The viscosity number shall be determined in accordance with ISO 1628-3 using a 0,02 % solution by mass of the material in decahydronaphtha
31、lene (decalin) at 135 C. 8.3 Ash content The ash content shall be determined in accordance with ISO 3451-1 performing duplicate tests on each of two test specimens at (700 50) C. The average of the results on the two test specimens shall not exceed the value given in Table 2. 8.4 Trace elements The
32、amounts of the trace elements shall be determined using the methods given in Table 3. Table 3 Methods of test for trace elements Element Method of test Titanium Atomic absorption or emission spectroscopy Aluminium Atomic absorption or emission spectroscopy Calcium Atomic absorption or emission spect
33、roscopy Chlorine Ion chromatography in accordance with DIN 53474 or equivalent 8.5 Particulate matter Mix each of four test portions of (75 5) g of the moulding material with (400 10) ml of propan-2-ol, in four 1 000 ml conical flasks. Shake each flask until the powder is thoroughly dispersed. Exami
34、ne the flasks with normal or corrected vision no less than 5 min after cessation of shaking and count the number of particles that settle to the bottom of each flask. 9 Test certificate Each lot shall be supplied with a test certificate stating the results of the tests conducted and conformance with
35、 the requirements of this part of ISO 5834. The test certificate shall include the following information: a) test values obtained in Clauses 7 and 8 as appropriate; b) statement of powder type, i.e. Type 1, Type 2 or Type 3; c) lot number; d) date(s) of test. BS ISO 5834-1:2005 Licensed Copy: sheffi
36、eldun sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 10 Labelling Each package of moulding material shall be clearly marked with at least the following information: a) manufacturers name or trademark; b) description of contents; c) lot number; d) mass of the conten
37、ts; e) the number of this part of ISO 5834, i.e. ISO 5834-1:2005. BS ISO 5834-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:56:38 GMT+00:00 2006, Uncontrolled Copy, (c)
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