BS 7252-6-1997 Metallic materials for surgical implants - Specification for wrought cobalt-nickel-chromium-molybdenum alloy《外科植入物用金属材料 可锻钴-镍-铬-钼合金规范》.pdf

1、BRITISH STANDARD BS7252-6: 1997 ISO5832-6: 1997 Metallic materials for surgical implants Part6: Specification for wrought cobalt-nickel-chromium-molybdenum alloy ICS 11.040.40BS7252-6:1997 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, wasp

2、ublished under the authorityof the Standards Boardand comes into effect on 15 October1997 BSI 09-1999 ISBN 0 580 28709 2 National foreword This British Standard reproduces verbatim ISO5832-6:1997 and implements it as the UK national standard. It supersedes BS7252-6:1990 which is withdrawn. The UK pa

3、rticipation 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 enquiries on the

4、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 The British Stand

5、ards 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 “Find” facility of the BSI Standards Electronic Catalogue. A British Standar

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

7、 inside front cover, pagesi and ii, theISO title page, pages ii to iv, pages1 and 2 and abackcover. 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 publicati

8、on Amd. No. Date CommentsBS7252-6:1997 BSI 09-1999 i Contents Page National foreword Inside front cover Foreword iii Text of ISO5832-6 1ii blankBS 7252-6:1997 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 Mec

9、hanical properties 1 6 Test methods 1 Table 1 Chemical composition 1 Table 2 Mechanical properties 2 Table 3 Test methods 2 Descriptors: Medical equipment, surgical implants, metallurgical products, cobalt alloys, nickel containing alloys, chromium containing alloys, molybdenum containing alloys, sp

10、ecifications, materials specifications, chemical composition, microstructure, mechanical properties, tests.BS 7252-6:1997 BSI 09-1999 iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparin

11、g 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-governmental, in liai

12、son 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 voting. Publicatio

13、n as an International Standard requires approval by at least75% of the member bodies casting a vote. International Standard ISO5832-6 was prepared by Technical Committee ISO/TC150, Implants for surgery, Subcommittee SC1, Materials. This second edition cancels and replaces the first edition (ISO5832-

14、6:1980), which has been technically revised. ISO5832 consists of the following parts, under the general title Implants for surgeryMetallic materials: Part1: Wrought stainless steel; Part2: Unalloyed titanium; Part3: Wrought titanium6-aluminium4-vanadium alloy; Part4: Cobalt-chromium-molybdenum casti

15、ng alloy; Part5: Wrought cobalt-chromium-tungsten-nickel alloy; Part6: Wrought cobalt-nickel-chromium-molybdenum alloy; Part7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy; Part8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy; Part9: Wrought high nitrogen st

16、ainless steel; Part10: Wrought titanium5-aluminium2,5-iron alloy; Part11: Wrought titanium6-aluminium7-niobium alloy; Part12: Wrought cobalt-chromium-molybdenum alloy.iv blankBS 7252-6:1997 BSI 09-1999 1 Introduction No known surgical implant material has ever been shown to cause absolutely no adver

17、se 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 Scope This part of ISO5832 specifi

18、es the characteristics of, and corresponding test methods for, wrought cobalt-nickel-chromium-molybdenum alloy for use in the manufacture of surgical implants. NOTEThe mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specificat

19、ions 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 publication, the editions indicated were valid. All standards are subject to revision, and partie

20、s 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 currently valid International Standards. ISO643:1983, SteelsMicrographic determination of th

21、e ferritic or austenitic grain size. ISO6892:, Metallic materialsTensile testing at ambient temperatures 1) . 3 Chemical composition The heat analysis of a representative sample of the alloy when determined in accordance with clause6 shall comply with the chemical composition specified in Table 1. T

22、able 1 Chemical composition 4 Microstructure The microstructure of the alloy shall be uniform. The grain size, determined in accordance with clause6, shall not be coarser than grain size No.4. 5 Mechanical properties The tensile properties of the alloy, when tested in accordance with clause6, shall

23、comply with the values specified in Table 2. NOTE 1The mechanical properties of this material can be altered by cold-working and cold-working plus ageing processes. Should any of the test pieces not meet the specified requirements, or should they break outside the gauge limits, two further test piec

24、es representative of the same batch shall be tested in the same manner. The alloy shall be deemed to comply only if both additional test pieces meet the specified requirements. NOTE 2However, the manufacturer may re-heat-treat the material and resubmit it for testing in accordance with the requireme

25、nts of this part of ISO5832. 6 Test methods The test methods to be used in determining compliance with the requirements of 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. 1)

26、To be published. (Revision of ISO6892:1984) Element Compositional limits, % (m/m) Nickel Chromium Molybdenum Iron Titanium Manganese Silicon Carbon Phosphorus Sulfur Cobalt 33,0 to37,0 19,0 to21,0 9,0 to10,5 1,0max. 1,0max. 0,15max. 0,15max. 0,025max. 0,015max. 0,010max. BalanceBS 7252-6:1997 2 BSI

27、09-1999 Table 2 Mechanical properties Table 3 Test methods Condition Tensile strength R m min. MPa Proof stress of non-proportionalelongation R p 0,2 min. MPa Percentage elongation after fracture a A min. % Annealed Medium Hard Hard 800 1000 1200 300 650 1000 40 20 10 a Gauge length= or50mm, where S

28、 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 properties 5 ISO6892 5,65S oblankBS7252-6: 1997 ISO5832-6: 1997 BSI 389 Chiswick

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