BS ISO 5834-1-2005 Implants for surgery - Ultra-high-molecular-weight polyethylene - Powder form《外科植入物 超高分子量聚乙烯 粉剂型》.pdf

1、BRITISH STANDARD BS ISO 5834-1:2005 Incorporating corrigendum no. 1 Implants for surgery Ultra-high- molecular-weight polyethylene Part 1: Powder form ICS 11.040.40 BS ISO 5834-1:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 10 Novembe

2、r 2005 BSI 2008 ISBN 978 0 580 60920 6 National foreword This British Standard is the UK implementation of ISO 5834-1:2005, incorporating corrigendum May 2007. It supersedes BS ISO 5834-1:1998 which is withdrawn. The start and finish of text introduced or altered by corrigendum is indicated in the t

3、ext by tags. Text altered by ISO corrigendum May 2007 is indicated in the text by . 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). A list of organizations represented on this subc

4、ommittee can be obtained on request to its secretary. 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 cannot confer immunity from legal obligations. Amendments/corrigenda is

5、sued since publication Date Comments 31 January 2008 Implementation of ISO corrigendum May 2007 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 Polyt

6、hylne trs haute masse molculaire Partie 1: Produits sous forme de poudre BS ISO 5834-1:2005ii BS ISO 5834-1:2005iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standa

7、rds is normally carried out through ISO technical committees. Each member body interested 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 tak

8、e part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) 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

9、 to prepare International Standards. 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. Attention is drawn to the possibilit

10、y 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 rights. ISO 5834-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. This third edition cancels

11、 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: Accelerated ageing methods Part

12、4: Oxidation index measurement method Part 5: Morphology assessment method blank 1 Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form 1 Scope This part of ISO 5834 specifies the requirements and corresponding test methods for moulding materials in powder form made from

13、 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 application of this document. For dated references, only the edition cite

14、d 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: Polyethylenes and polypropylenes ISO 3451-1, Plastics Determinat

15、ion 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-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materia

16、ls 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 document, the terms and definitions given in ISO 11542-1 and IS

17、O 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. BS ISO 5834-1:20052 5 Manufacturing requirements The material shall consist of a

18、 homopolymer prepared by the polymerization of ethylene. The powdered material 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 dete

19、rmined by measuring either elongation stress or viscosity number. When measured 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 Fl

20、ow 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 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 contami

21、nation 7.1 Ash and trace elements When measured using the appropriate test method, 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 Maximu

22、m quantity permitted mg/kg Element Type 1 Type 2 Type 3 aTest method according 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 aType 3 polymer is no longer manufactured. However, in order to cover existing supplies held in stoc

23、kpile, 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 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

24、 Type 3 materials (see Footnote to Table 2), per (300 20) g tested. BS ISO 5834-1:2005 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 the influence of ultraviolet r

25、adiation. 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 decahydronaphthalene (decalin) at 135 C. 8.3 As

26、h 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 amounts of the trace elements s

27、hall 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 spectroscopy Chlorine Ion chromatogr

28、aphy 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. Examine the flasks with normal or co

29、rrected 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 the requirements of this part

30、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 5834-1:20054 10 Labelling Each package of moulding material shal

31、l 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. BS ISO 5834-1:2005 blankBS ISO 5834-1:2005 BSI 389 Chiswick High Road Lon

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