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1、BRITISH STANDARD BS ISO 5834-2:1998 Implants for surgery Ultra-high molecular weight polyethylene Part 2: Moulded forms ICS 11.040.40 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 5834-2:1998 This British Standard, having been prepa
2、red under the direction of the Health and Enviroment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 October 1998 BSI 05-1999 ISBN 0 580 30613 5 National foreword This British Standard reproduces verbatim ISO 5834-2:1998 and implements it as the UK
3、national standard. It supersedes BS 7253-5:1990 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee Surgical implant materials, to Subcommittee CH/18/1, Non-metallic materials, which has the responsibility to: aid enquirers to understand the text; present
4、 to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this subcommittee can b
5、e obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “F
6、ind” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from leg
7、al obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the ISO title page, pages ii to iv, pages 1 to 3 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in th
8、e amendment table on the inside front cover. Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 5834-2:1998 BSI 05-1999i Contents Page National foreword Inside front cover Foreword
9、 iii Text of ISO 5834-2 1 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov
10、 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 5834-2:1998 ii BSI 05-1999 Contents Page Foreword iii 1 Scope 1 2 Normative references 1 3 Definitions 1 4 Classification 1 5 Material 1 6 Manufacturing requirements 1 7 Requirements 1 8 Test methods 1 9 Identification marking 2 10 Test
11、certificate 2 11 Labelling 3 Table 1 Physical properties 2 Descriptors: Surgical implants, polyethylene, specifications, properties, tests, marking, labelling, medical equipment, castings. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS I
12、SO 5834-2:1998 BSI 05-1999iii 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 interes
13、ted 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 with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical C
14、ommission (IEC) on all matters of electrotechnical standardization. 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. Inter
15、national Standard ISO 5834-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. This second edition cancels and replaces the first edition (ISO 5834-2:1985), which has been technically revised. ISO 5834 consists of the following parts, under the gener
16、al title Implants for surgery Ultra-high molecular weight polyethylene: Part 1: Powder form; Part 2: Moulded forms. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:42 GMT+
17、00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 5834-2:1998 BSI 05-19991 1 Scope This part of ISO 5834 specifies the requirements and corresponding test methods for moulded forms made from ultra-high molecular weight polyethylene (PE-UHMW) for use in the manufacture of surgical implants. It does not a
18、pply to direct-moulded or finished products. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 5834. At the time of publication, the editions indicated were valid. All the standards are subject to revisi
19、on, and the parties to agreements based on this part of ISO 5834 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standard. ISO 527:1976, Plastics Determinat
20、ion of tensile properties. ISO 1183:1987, Plastics Methods for determining the density and relative density of non-cellular plastics. ISO 3451-1:1997, Plastics Determination of ash Part 1: General methods. ISO 5834-1:1998, Implants for surgery Ultra-high molecular weight polyethylene Part 1: Powder
21、form. ISO 11542-1:1994, Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 1: Designation systems and basis for specifications. ISO 11542-2:, Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 2: Preparatio
22、n of test specimens and determination of properties1). ASTM F 648, Standard specification for ultra-high molecular weight polyethylene powder and fabricated form for surgical implants. 3 Definitions For the purposes of this part of ISO 5834, the definitions given in ISO 11542-1 and ISO 11542-2 apply
23、. NOTEThe PE-UHMW powder, semi-finished and finished products for this application do not contain light stabilizers and should therefore be protected against the influence of ultraviolet radiation. 4 Classification The material moulded from Type 1, Type 2 or Type 3 powder as defined in ISO 5834-1 sh
24、all be classified as Type 1, Type 2 or Type 3 respectively. 5 Material The material shall be moulded from PE-UHMW powder complying with the requirements of ISO 5834-1. 6 Manufacturing requirements The moulded material supplied for each order shall be identified by lot numbers. NOTE 1“Lot” refers to
25、the material for which testing has been carried out and for which discrete records are kept. NOTE 2The 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 7.1 Physical prope
26、rties When measured using the appropriate test method, as defined in Table 1, the physical properties of the moulded material shall be as per the relevant values given in Table 1 for each type of material. 7.2 Particulate matter When inspected using normal or corrected vision, not more than 10 parti
27、cles shall be visible on the surface of a sample(s) prepared in accordance with 8.8. 8 Test methods 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
28、 test specimen for at least 16 h under these conditions. 8.2 Density The density shall be measured by means of method A (buoyancy procedure) specified in ISO 1183:1987 using at least three specimens. The average of the results on the three test specimens shall not exceed the value given in Table 1.
29、8.3 Ash content The ash content shall be measured 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 1. 1) To be published. Licensed Copy: sheffieldun sh
30、effieldun, na, Sun Nov 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 5834-2:1998 2 BSI 05-1999 Table 1 Physical properties 8.4 Tensile stress at yield The tensile stress at yield $B shall be determined by the tensile test specified in ISO 527 on at least five test specimens of thickn
31、ess (1,5 0,5) mm using a test speed of (100 10) mm/min. The average of the results on the five test specimens shall not be less 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 average of the results
32、 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 R, shall be measured during the test described in 8.4. The average of the results on the five test specimens shall not be less than the values quoted in Table 1. 8.7 Notch
33、ed impact strength The notched impact strength aCN shall be determined by the impact test specified in either Annex B of ISO 11542-2: (Charpy) or ASTM F 648 (Izod). In case of doubt or dispute, the test method specified in ISO 11542-2 shall be used as the reference method. 8.8 Sample area for partic
34、ulate matter A total machined surface area of (320 103) mm2 shall be taken from locations within the fabricated form. The area examined shall include both transverse and longitudinal samples or may be produced by repeated sectioning through the thickness of the fabricated form. 9 Identification mark
35、ing Each item supplied shall be identified with an impressed identification number. NOTEThe marking, which may also be a serial 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
36、stating the results of the tests conducted in conformance with the requirements of this part of ISO 5834. The test certificate shall include the following information: a) the number of this International Standard (ISO 5834-2); b) statement of material type, i.e. Type 1, Type 2 or Type 3; c) lot numb
37、er or serial number with reference to the lot number; d) number of items; e) test values according to the appropriate clauses of this part of ISO 5834; f) date(s) of test. PropertyUnitRequirementRequirementRequirementTest method according to subclause Type 1Type 2Type 3 Density kg/m3 927 to 944927 t
38、o 944927 to 9448.2 Ash contentamg/kg150 max.150 max.300 max.8.3 Tensile stress $B at yieldbMPa21 min.19 min.19 min.8.4 Tensile stress $R at breakbMPa35 min.27 min.27 min.8.5 Elongation at break Rb%300 min.300 min.250 min.8.6 Double-notched impact strength Charpy aCN kJ/m2180 min.90 min.30 min.8.7 Do
39、uble-notched impact strength IzodkJ/m2140 min.73 min.25 min.8.7 a When determining ash content, it should be noted that in certain cases mould-release agents based on silicone are used in the production of the moulded forms. The residual mould-release agent on and in the moulded form will therefore
40、be included in the determination of the ash. The upper limit of silica content (SiO2) from ashing is considered to be 20 mg/kg. b The minimum values given in this table apply to the average of the results for the specimens tested. Individual test specimen results may be below this minimum. Licensed
41、Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 5834-2:1998 BSI 05-19993 11 Labelling Each package of moulded material shall be clearly marked with at least the following information: a) manufacturers name or trademark; b) description of conte
42、nts; c) lot number; d) mass of the contents; e) the number of this International Standard (ISO 5834-2). Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 5834-2:1998 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institu
43、tion BSI is the independent national body responsible for preparing British Standards. It presents 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 shou
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