1、DEUTSCHE NORM Auaust 2000 I DIN Implants for surgery - Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- - I IS0 5832-8 tungsten-iron alloy (IS0 5832-8 : 1997) ICs 11.040.40; 77.120.99 Chirurgische Implantate - Metallische Werkstoffe - Teil 8: Kobalt-Nickel-Chrom-Molybdn-Wolfram-
2、 Eisen-Schmiedelegierung (IS0 5832-8 : 1997) This standard incorporates International Standard IS0 5832-8 Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybde- num-tungsten-iron alloy. A comma is used as the decimal marker. National foreword This standard has be
3、en prepared by ISO/TC 150 Implants for surgery. The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Technical Committee Implantatwerkstoffe. IS0 Standard comprises 3 pages. No pari of this standa
4、rd may be reproduced without the prior permission of Ref. No. DIN IS0 5832-8 : 2000-0 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 12.00 Page 1 IS0 5832-
5、8 : 1997 Implants for surgery - Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International
6、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 committee. International organizations, governmental and non- governmental, in liaison with ISO, a
7、lso 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 the technical committees are circulated to the member bodies for voting. Publication as an Interna
8、tional Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard IS0 5832-8 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. This second edition cancels and replaces the first edition (IS0 5832-8:1987),
9、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 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron Pari 7: Wrought stainless steel Pari 3: Wrought
10、titanium 6-aluminium 4-vanadium alloy Part 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-iron alloy alloy Part 9: Wrought h
11、igh nitrogen stainless steel fart 10: Wrought titanium 5-aluminium 2,5-iron alloy Part 1 1: Wrought titanium 6-aluminium 7-niobium alloy Part 72: Wrought cobalt-chromium-molybdenum alloy - - - - Introduction No known surgical implant material has ever been shown to cause absolutely no adverse reacti
12、ons in the human body. However, long-term clinical experience of the use of the material referred to in this pari of IS0 5832 has shown that an acceptable level of biological response can be expected, when the material is used in appropriate applications, Page 2 IS0 5832-8 : 1997 Contents Page 1 Sco
13、pe 2 2 Normative references 2 3 Chemical composition . 2 4 Microstructure 2 5 Mechanical properties 3 6 Test methods . 3 1 Scope This part of IS0 5832 specifies the characteristics of, and the corresponding test methods for, wrought cobalt-nickel- chromium-molybdenum-tungsten-iron alloy for use in t
14、he manufacture of surgical implants. NOTE - The mechanical properties of a sample obtained from a finished product made of this alloy depend on the treatment undergone, and may not necessarily comply with the specifications given in this part of IS0 5832. 2 Normative references The following standar
15、ds contain provisions which, through reference in this text, constitute provisions of this part of 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 part of IS0 5832 are encouraged to investigate th
16、e possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 643: 198311, Steels - Micrographic determination of the ferritic or austenitic grain size. IS0 6892:-2), Metallic materials -
17、 Tensile testing at ambient temperatures. 3 Chemical composition The heat analysis of a representative sample of the alloy when determined in accordance with clause 6 shall comply with the chemical composition specified in table 1. 4 Microstructure The microstructureJ) shall be uniform and single-ph
18、ased in the annealed condition. The grain size in the annealed condition, determined in accordance with clause 6, shall not be coarser than grain size No. 5. 1) IS0 643 is given as a reference, even though the material dealt with in this part of Is0 5832 is not iron-based. 2) To be published. (Revis
19、ion of IS0 6892:1984) 3) For determination of the microstructure, the following etching reagent may be used: 10 mi of nitric acid (p20 = 1.4 kg/l) plus 1 O0 ml of hydrochloric acid (p 20 = 1,19 kg/l) plus 0.3 ml of Vogels Sparbeize plus 1 O0 ml of distilled water. Page 3 IS0 5832-8 : 1997 Condition
20、r Fully annealed Cold-worked or cold-worked and aged Medium hard Hard Extra hard 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. Tensile strength Proof stress of non- Percentage elongation after
21、I proportional elongation f racturel ) Rp 02 A Rrn min. min. min. MPa MPa % 600 275 50 1 O00 830 18 1310 1170 12 1 580 1310 5 NOTE - The mechanical properties of this material can be altered by cold-working and colci-working plus ageing processes, Parameter Relevant clause Chemical composition 3 Gra
22、in size 4 6 Test methods The test methods to be used in determining compliance with this part 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. Test method Recognized analytical proced
23、ures (IS0 methods where these exist) 1SO 643 Table 1 - Chemical composition echanical properties Element Cobalt Nickel Chromium Molybdenum Tungsten Iron Titanium Carbon Manganese Silicon Sulfur 5 I IS06892 Compositional limits, % (mim) Balance 150 to 25,O 18,O to 22.0 3,O to 4,O 3,O to 4,O 4,O to 6,O 0,s to 330 0,05 max. 1 ,O0 max. 050 max. 0,Ol O max. Table 2 - Mechanical properties
