1、DEUTSCHE NORM Amil 2001 Implants for surgery - Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (IS0 5832-6 : 1997) DIN IS0 5832-6 - ICs 11.040.40; 77.120.99 Chirurgische Implantate - Metallische Werkstoffe - Teil 6: Kobalt-Nickel-Chrom-Molybdn-Schmiedelegierung (IS0 5832-6
2、 : 1997) This standard incorporates International Standard IS0 5832-6 Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium- molybdenum alloy. A comma is used as the decimal marker. National foreword This standard has been prepared by ISO/TC 150 Implants for surgery. The
3、 responsible German body involved in its preparation was the Normenausschuss Feinmechanikund Optik (Optics and Precision Mechanics Standards Committee), Technical Committee Implantatwerkstoffe. IS0 Standard comprises 4 pages. No pari of this standard may be reproduced without the prior permission of
4、 Ref. No. DIN IS0 5832-6 : 2001 -0 Y Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany, s the exclusive right of sale for German Standards (DIN-Normen). English price group 06 Sales No. 0406 08.01 Page 1 IS0 5832-6 : 1997 Implants for surgery - Metallic materials
5、Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy Contents Page 1 Scope 3 2 Normative references 3 3 Chemical composition . 3 4 Microstructure 4 5 Mechanical properties 4 6 Test methods . 4 Page 2 IS0 5832-6 : 1997 Foreword IS0 (the International Organization for Standardization) is a worldwid
6、e federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 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
7、 committee. International organizations, governmental and non- governmental, in liaison with ISO, also take part in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by
8、 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. International Standad IS0 5832-6 was prepared by Technical Committee ISOTTC 150, Implants for surgery, Subcommitt
9、ee SC 1, Materials. This second edition cancels and replaces the first edition (IS0 5832-63 980), which has been technically revised. IS0 5832 consists of the following parts, under the general title Implants for surgery - Metallic materials: - - Part 2: Unalloyed titanium - - - - - Part 1: Wrought
10、stainless steel Part 3: Wrought titanium 6-aluminium 4-vanadium alloy Pari 4: Cobalt-chromium-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-ir
11、on alloy alloy Part 9: Wrought high nitrogen stainless steel Part 10: Wrought titanium 5-aluminium 2,5-iron alloy Part 1 1: Wrought titanium 6-aluminium 7-niobium alloy Part 12: Wrought cobalt-chromium-molybdenum alloy - Pari 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron - - - - Page 3
12、IS0 5832-6 : 1997 Introduction No known surgical implant material has ever been shown 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 IS0 5832 has shown that an acceptable level of biological re
13、sponse can be expected, when the material is used in appropriate applications. 1 Scope This part of IS0 5832 specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel- chromium-molybdenum alloy for use in the manufacture of surgical implants. NOTE - The mechanical p
14、roperties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of IS0 5832. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this pari of
15、IS0 5832. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this pari of IS0 5832 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC
16、 and IS0 maintain registers of currently valid International Standards. IS0 643:1983, Steels - Micrographic determination of the ferritic or austenitic grain size. IS0 6892:-1), Metallic materials - Tensile testing at ambient temperatures. 3 Chemical composition The heat analysis of a representative
17、 sample of the alloy when determined in accordance with clause 6 shall comply with the chemical composition specified in table 1. Table 1 - Chemical composition Element Nickel Chromium Molybdenum Iron Titanium Manganese Silicon Carbon Phosphorus Sulfur Cobalt Compositional limits, % (rnlrn) 33,O to
18、37,O 19,0 to 21 ,o 9.0 to 10,5 1 ,O max. 1 ,O max. 0,15 max. 0,15 max. 0,025 max. 0,015 max. 0,010 max. Balance 1) To be published. (Revision of IS0 6892:1984) Page 4 IS0 5832-6 : 1997 Proof stress of non- proportional elongation Rp 02 4 Microstructure The microstructure of the alloy shall be unifor
19、m. The grain size, determined in accordance with clause 6, shall not be coarser than grain size No. 4. Percentage elongation after fracture ) pi 5 Mechanical properties The tensile properties of the alloy, when tested in accordance with clause 6, shall comply with the values specified in table 2. mi
20、n. min. min. M Pa M Pa % Annealed 800 300 40 Medium Hard 1 O00 650 20 Hard 1 200 1 O00 10 - 1) Gauge length = 5,65& or 50 mrn, where So is the original cross-sectional area, in square millimetres. NOTE 1 The mechanical properties of this material can be altered by cold-working and cold-working plus
21、ageing processes Parameter Chemical composition Grain size Should any of the test pieces not meet the specified requirements, or should they break outside the gauge limits, two further test pieces representative of the same batch sRall be tested in the same manner. The alloy shall be deemed to compl
22、y only if both additional test pieces meet the specified requirements. Relevant clause Test method 3 4 IS0 643 Recognized analytical procedures (IS0 methods where these exist) NOTE 2 However, the manufacturer may re-heat-treat the material and resubmit it for testing in accordance with the requireme
23、nts of this part of IS0 5832. Mechanical properties Table 2 - Mechanical properties 5 IS0 6892 Tensile strength Rrn 6 Test methods The test methods to be used in determining compliance with the requirements of this pari of IS0 5832 shall be those given in table 3. Representative test pieces for the determination of mechanical properties shall be prepared in accordance with IS0 6892.
