BS 7252-8-1997 Metallic materials for surgical implants - Specification for wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy《外科植入物用金属材料 可锻钴-镍-铬-钼-钨-铁合金规范》.pdf

1、BRITISH STANDARD BS7252-8: 1997 ISO 5832-8: 1997 Metallic materials for surgical implants Part 8: Specification for wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy ICS 11.040.40BS7252-8:1997 This British Standard, having been prepared under the directionof the Health and Environment S

2、ector Board, waspublished under the authorityof the Standards Boardand comes into effect on 15October1997 BSI 09-1999 ISBN 0 580 28706 8 National foreword This British Standard reproduces verbatim ISO5832-8:1997 and implements it as the UK national standard. It supersedes BS7252-8:1990 which is with

3、drawn. The UK participation in its preparation was entrusted by Technical Committee CH/18, Surgical implant materials, to Subcommittee CH/18/2, Metallic materials, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any e

4、nquiries 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 be obtained on request to its secretary. Cross-references T

5、he British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does

6、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 legal obligations. Summary of pages This document comprises a front cover, an inside

7、 front cover, pagesi andii, theISO title page, pages ii to iv, pages1 and2 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd.

8、 No. Date CommentsBS7252-8:1997 BSI 09-1999 i Contents Page National foreword Inside front cover Foreword iii Text of ISO 5832-8 1ii blankBS7252-8:1997 ii BSI 09-1999 Contents Page Foreword iii Introduction 1 1 Scope 1 2 Normative references 1 3 Chemical composition 1 4 Microstructure 1 5 Mechanical

9、 properties 1 6 Test methods 1 Table 1 Chemical composition 1 Table 2 Mechanical properties 2 Table 3 Test methods 2 Descripteurs: Matriel mdical, implant chirurgical, produit mtallurgique, produit corroy, alliage de cobalt, alliage au nickel, alliage au chrome, alliage au molybdne, alliage au tungs

10、tne, alliage au fer, spcification, spcification de matire, composition chimique, microstructure, proprit mcanique, essai.BS 7252-8:1997 BSI 09-1999 iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The wo

11、rk of preparing International Standards 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-governm

12、ental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voti

13、ng. Publication as an International Standard requires approval by at least75% of the member bodies casting a vote. International Standard ISO5832-8 was prepared by Technical Committee ISO/TC150, Implants for surgery, Subcommittee SC1, Materials. This second edition cancels and replaces the first edi

14、tion (ISO5832-8:1987), which has been technically revised. ISO5832 consists of the following parts, under the general title Implants for surgery Metallic materials: Part 1: Wrought stainless steel; Part 2: Unalloyed titanium; Part 3: Wrought titanium 6-aluminium 4-vanadium alloy; Part 4: Cobalt-chro

15、mium-molybdenum casting alloy; Part 5: Wrought cobalt-chromium-tungsten-nickel alloy; Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy; Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy; Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy; Part 9

16、: Wrought high nitrogen stainless steel; Part 10: Wrought titanium 5-aluminium 2,5-iron alloy; Part 11: Wrought titanium 6-aluminium 7-niobium alloy; Part 12: Wrought cobalt-chromium-molybdenum alloy.iv blankBS 7252-8:1997 BSI 09-1999 1 Introduction No known surgical implant material has ever been s

17、hown to cause absolutely no adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in this part of ISO5832 has shown that an acceptable level of biological response can be expected, when the material is used in appropriate applications. 1 S

18、cope This part of ISO5832 specifies the characteristics of, and the corresponding test methods for, wrought cobalt-nickel-chromium-molybdenum-tungsten- iron alloy for use in the manufacture of surgical implants. NOTEThe mechanical properties of a sample obtained from a finished product made of this

19、alloy depend on the treatment undergone, and may not necessarily comply with the specifications given in this part of ISO5832. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO5832. At the time of public

20、ation, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO5832 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 c

21、urrently valid International Standards. ISO643:1983, Steels Micrographic determination of the ferritic or austenitic grain size 1) . ISO6892:, Metallic materials Tensile testing at ambient temperatures 2) . 3 Chemical composition The heat analysis of a representative sample of the alloy when determi

22、ned in accordance with clause6 shall comply with the chemical composition specified in Table 1. 4 Microstructure The microstructure 3)shall be uniform and single-phased in the annealed condition. The grain size in the annealed condition, determined in accordance with clause6, shall not be coarser th

23、an grain size No.5. 5 Mechanical properties The tensile properties of the alloy, when tested in accordance with clause6, shall comply with the values specified in Table 2. NOTEThe mechanical properties of this material can be altered by cold-working and cold-working plus ageing processes. 6 Test met

24、hods The test methods to be used in determining compliance with this part of ISO5832 shall be those given in Table 3. Representative test pieces for the determination of mechanical properties shall be prepared in accordance with ISO6892. Table 1 Chemical composition 1) ISO643 is given as a reference

25、, even though the material dealt with in this part of ISO5832 is not iron-based. 2) To be published. (Revision of ISO6892:1984) 3) For determination of the microstructure, the following etching reagent may be used:10ml of nitric acid ( 20 =1,4kg/l) plus100ml of hydrochloric acid ( 20 =1,19kg/l) plus

26、0,3ml of Vogels Sparbeize plus100ml of distilled water. Element Compositional limits, % (m/m) Cobalt Nickel Chromium Molybdenum Tungsten Iron Titanium Carbon Manganese Silicon Sulfur Balance 15,0 to 25,0 18,0 to 22,0 3,0 to4,0 3,0 to4,0 4,0 to6,0 0,5 to3,50 0,05max. 1,00max. 0,50max. 0,010max.BS 725

27、2-8:1997 2 BSI 09-1999 Table 2 Mechanical properties Table 3 Test methods Condition Tensilestrength R m min. MPa Proof stress of non-proportional elongation R p 0,2 min. MPa Percentageelongation afterfracture a A min. % Fully annealed 600 275 50 Cold-worked or cold-worked and aged Medium hard Hard E

28、xtra hard 1000 1310 1580 830 1170 1310 18 12 5 a Gauge length=5or50mm, where S ois the original cross-sectional area, in square millimetres. Parameter Relevant clause Test method Chemical composition 3 Recognized analytical procedures (ISO methods where these exist) Grain size 4 ISO643 Mechanical pr

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