DIN ISO 5834-2-2014 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2 Moulded forms (ISO 5834-2 2011)《外科植入物 超高分子量聚乙烯 第2部分 模塑型(ISO 5834-2-2011)》.pdf

1、February 2014Translation by DIN-Sprachendienst.English price group 7No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS

2、 11.040.40; 83.140.99!%,Bc“2093164www.din.deDDIN ISO 5834-2Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms (ISO 5834-2:2011),English translation of DIN ISO 5834-2:2014-02Chirurgische Implantate Ultrahochmolekulares Polyethylen Teil 2: Halbzeuge (ISO 5834-2:2011),E

3、nglische bersetzung von DIN ISO 5834-2:2014-02Implants chirurgicaux Polythylne trs haute masse molculaire Partie 2: Produits sous forme moule (ISO 5834-2:2011),Traduction anglaise de DIN ISO 5834-2:2014-02SupersedesDIN ISO 5834-2:2007-12www.beuth.deIn case of doubt, the German-language original shal

4、l be considered authoritative.Document comprises 9 pages02.14 A comma is used as the decimal marker. Contents Page National foreword .3 National Annex NA (informative) Bibliography .4 1 Scope .5 2 Normative references .5 3 Classification 5 4 Material 5 5 Manufacturing requirements .5 6 Requirements

5、6 6.1 Physical properties 6 6.2 Particulate matter .6 7 Test methods .6 7.1 Test conditions .6 7.2 Density .6 7.3 Ash .7 7.4 Tensile stress at yield 7 7.5 Tensile stress at break .7 7.6 Elongation at break 7 7.7 Notched impact strength .7 7.8 Sample area for extraneous matter 7 8 Identification mark

6、ing 7 9 Test certificate .7 10 Labelling 8 Bibliography 9 2DIN ISO 5834-2:2014-02National foreword This document (ISO 5834-2:2011) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 1 “Materials” (Secretariat: DIN, Germany). The responsible German body involv

7、ed in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-02-06 AA Implantat-werkstoffe. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN

8、 shall not be held responsible for identifying any or all such patent rights. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 527-1 DIN EN ISO 527-1 ISO 1183-1 DIN EN ISO 1183-1 ISO 3451-1 DIN EN ISO 3451-1 ISO 5834-1 DIN ISO 5834-1 ISO

9、 11542-1 DIN EN ISO 11542-1 ISO 11542-2 DIN EN ISO 11542-2 Amendments This standard differs from DIN ISO 5834-2:2007-12 as follows: a) Clause 1 “Scope” has been rendered more precise and indicates products for which this standard is not applicable; b) Clause 3 “Terms and definitions” has been delete

10、d; c) Clause 5 “Manufacturing requirements” now excludes the use of liquid or powdery release agents in the moulding process; d) in Subclause 6.1 “Physical properties”, the recommendation concerning the measurement of the physical properties has been replaced by an appropriate requirement; e) the st

11、andard has been editorially revised. Previous editions DIN 58836: 1979-06 DIN ISO 5834-2: 2000-08, 2007-12 DIN ISO 5834-2 Corrigendum 1: 2004-02 3DIN ISO 5834-2:2014-02National Annex NA (informative) Bibliography DIN EN ISO 527-2, Plastics Determination of tensile properties Part 1: General principl

12、es DIN EN ISO 1183-1, Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, liquid pyknometer method and titration method DIN EN ISO 3451-1, Plastics Determination of ash Part 1: General methods DIN EN ISO 11542-1, Plastics Ultra-high-molecular-weight polyet

13、hylene (PE-UHMW) moulding and extrusion materials Part 1: Designation system and basis for specifications DIN EN 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 ISO 583

14、4-1, Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form 4DIN ISO 5834-2:2014-021 ScopeThis part of ISO 5834 specifies the requirements and corresponding test methods for moulded forms, e.g. sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) fo

15、r use in the manufacture of surgical implants.This part of ISO 5834 is not applicable to direct-moulded (near net shape), irradiated or finished products or products manufactured from polyethylene blended with additives or by blending different forms of polyethylene.2 Normative referencesThe followi

16、ng 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 527-1, Plastics Determination of tensile properties Part

17、1: General principlesISO 1183-1:1), Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, liquid pyknometer method and titration methodISO 3451-1:2008, Plastics Determination of ash Part 1: General methodsISO 5834-1, Implants for surgery Ultra-high-molecular

18、-weight polyethylene Part 1: Powder formISO 11542-2:1998, Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 2: Preparation of test specimens and determination of properties3 ClassificationThe material moulded from Type 1, Type 2 or Type 3 powder as def

19、ined in ISO 5834-1 shall be classified as Type 1, Type 2 or Type 3 respectively.4 MaterialThe moulded material shall be made from UHMWPE powder in accordance with the requirements of ISO 5834-1.5 Manufacturing requirementsThe moulded material supplied for each order shall be identified by lot number

20、s.NOTE “Lot” refers to the material for which testing has been carried out and for which discrete records are kept.The material shall 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).Implants for surgery Ultr

21、a-highmolecular-weight polyethylene Part 2: Moulded forms 5DIN ISO 5834-2:2014-02In the moulding process, no liquid or powdery release agents shall be used (such as silicon or talc-based release agent) in order to avoid contamination, migration and moulding defects.6 Requirements6.1 Physical propert

22、iesWhen 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 of material.The physical properties shall be measured on material in the consolidated and annealed state befo

23、re 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 magnification, not more than ten particles shall be visible on the surface of a sample or samples prepared in

24、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 944 7.2Ash, maximum mg/kg 150 150 300 7.3Tensile stress, y, at yield, minimumMPa 21 19 19 7.4Tensile stress, R

25、, 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 values given in this table are for the mean of the results for the specimens tested. Individual test specimen

26、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) shall be used as the reference method.bThe values in parentheses are determined in accordance with ASTM F648:2

27、007 (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 against the influence of ultraviolet radiation.7.1 Test conditionsUnless otherwise specified, the testing spe

28、cified 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 be measured by means of method A (immersion method) specified in ISO 1183-1, using at least three specimens.

29、The mean of the results on the three test specimens shall not exceed the value given in Table 1.6DIN ISO 5834-2:2014-027.3 AshThe ash shall be measured 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

30、 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 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 sp

31、ecimens 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 Table 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

32、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 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 1.7.7 Notched impact strengthTh

33、e double-notched impact strength, acN, shall be determined by the impact test specified in either ISO 11542-2:1998, Annex B (Charpy) or ASTM F648:2007 (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 mat

34、terA total machined surface area of (500 103) mm2shall be taken from locations within the fabricated form. The area examined shall include both transverse and longitudinal samples, or it may be produced by repeated sectioning through the thickness of the fabricated form.8 Identification markingEach

35、item supplied shall be identified with at least a lot identification. A marking, which can also be a serial identification, with reference to the lot identification, may be repeated at intervals along the length of the item.9 Test certificateEach lot shall be supplied with a test certificate stating

36、 the results of the tests conducted and conformance with the requirements of this part of ISO 5834. The test certificate shall include the following 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

37、 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 5834;f) description of the UHMWPE annealing treatment as agreed by the purchaser and the vendor.7DIN ISO 5834-2:2014-0210 LabellingEach package of moulded

38、material shall be clearly marked as agreed between the purchaser and vendor.8DIN ISO 5834-2:2014-02Bibliography1 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 Powder and Fabricated Form for Surgical Implants9DIN ISO 5834-2:2014-02