DIN ISO 5834-1-2007 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1 Powder form (ISO 5834-1 2005) English version of DIN ISO 5834-1 2007-06《外科植入物 超高分子量聚乙烯 .pdf

1、June 2007DEUTSCHE NORM English price group 7No part of this standard 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 11.040.40; 83.080.20!,y“98

2、62959www.din.deDDIN ISO 5834-1Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form (ISO 5834-1:2005)English version of DIN ISO 5834-1:2007-06Chirurgische Implantate Ultrahochmolekulares Polyethylen Teil 1: Formmassen (ISO 5834-1:2005)Englische Fassung DIN ISO 5834-1:2007

3、-06SupersedesDIN ISO 5834-1:2000-08www.beuth.deDocument comprises 7 pages 09.07National foreword This standard has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 1 “Materials”. The responsible German body involved in its preparation was the Normenausschuss Fe

4、inmechanik und Optik (Optics and Precision Mechanics Standards Committee), Technical Committee NA 027-02-06 AA Implantat-werkstoffe. The revision of ISO 5834-1:1998 was lead-managed by German experts. The DIN Standards corresponding to the International Standards referred to in clause 2 of this docu

5、ment are as follows: ISO 1628-3 DIN EN ISO 1628-3 ISO 3451-1 DIN EN ISO 3451-1 ISO 11542-1 DIN EN ISO 11542-1 ISO 11542-2 DIN EN ISO 11542-2 International Standard ISO 5834-1:2005 “Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form” has been adopted without any modific

6、ations. This third edition cancels and replaces the second edition (ISO 5834-1:1998), which has been technically revised. 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:

7、 Accelerated ageing methods Part 4: Oxidation index measurement method Part 5: Morphology assessment method Amendments This standard differs from DIN ISO 5834-1:2000-08 as follows: a) The maximum ash and trace element contents given in Table 2 have been amended to reflect the latest state of the art

8、. b) Type 3 material has been dropped and the relevant clauses have been amended accordingly. Previous editions DIN 58834: 1979-06 DIN ISO 5834-1: 2000-08 2 DIN ISO 5834-1:2007-06 DIN ISO 5834-1:2007-06 3 National Annex NA (informative) Bibliography DIN EN ISO 1628-3, Plastics Determination of visco

9、sity of polymers in dilute solution using capillary viscometers Part 3: Polyethylenes and polypropylenes DIN EN ISO 3451-1, Plastics Determination of ash Part 1: General methods DIN EN ISO 11542-1, Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 1: D

10、esignation 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 1 Scope This part of ISO 5834 specifies the requirements and correspon

11、ding 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 referenced documents are indispensable for the applicat

12、ion 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 dilute solution using capillary viscometers Part 3:

13、 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 specifications ISO 11542-2, Plastics Ultra-high-molec

14、ular-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-combustion) 3 Terms and definitions For the purposes of this

15、 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/trace element contents given in 7.1. 4 DIN ISO 5834-1

16、:2007-06 Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form 5 Manufacturing requirements The material shall consist of a homopolymer prepared by the polymerization of ethylene. The powdered material supplied for each order shall be identified by lot numbers. NOTE “Lot”

17、 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 measured using the appropriate test method, as defined in Table 1, the minimum

18、 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 according to subclause Elongational stress MPa 0,2 0,42 8.1 Viscosity nu

19、mber 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 method, as defined in Table 2, the amounts of ash, titanium, aluminium, ca

20、lcium 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 3aTest method according to subclause Ash 125 125 300 8.3 Titanium 40 40 150 8.4 Calcium 5 5 50

21、8.4 Chlorine 30 30 90 8.4 Aluminium 20 20 100 8.4 aType 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. 7.2 Particulate matter When measured using the test method g

22、iven 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. 5 DIN ISO 5834-1:2007-06 8 Test methods CAUTION The UHMWPE powder, semi-finished a

23、nd finished products for this application are not equipped with light stabilizers and should therefore be protected against 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 n

24、umber shall be determined in accordance with ISO 1628-3 using a 0,02 % solution by mass of the material in decahydronaphthalene (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

25、. The average of the results on the two test specimens shall not exceed the value given in Table 2. 8.4 Trace elements The 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 absorptio

26、n or emission spectroscopy Aluminium Atomic absorption or emission spectroscopy Calcium Atomic absorption or emission spectroscopy 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 (4

27、00 10) ml of propan-2-ol, in four 1 000 ml conical flasks. Shake each flask until the powder is thoroughly dispersed. Examine 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 cer

28、tificate Each lot shall be supplied with a test certificate stating 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) test values obtained in Clauses 7 and 8 as appropriate; b) statement

29、 of powder type, i.e. Type 1, Type 2 or Type 3; c) lot number; d) date(s) of test. 6 DIN ISO 5834-1:2007-06 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 contents; e) the number of this part of ISO 5834, i.e. ISO 5834-1:2005. 7 DIN ISO 5834-1:2007-06