GOST R ISO 5832-12-2009
GOST R ISO 5832−12−2009 Implants for surgery. The metallic materials. Part 12. The alloy cobalt-chromium-molybdenum wrought
GOST R ISO 5832−12−2009
Group В32
В73
NATIONAL STANDARD OF THE RUSSIAN FEDERATION
IMPLANTS FOR SURGERY
METALLIC MATERIALS
Part 12
The alloy cobalt-chromium-molybdenum wrought
Implants for surgery. Metallic materials. Part 12. Wrought cobalt-chromium-molybdenum alloy
OKS 11.040.40
OKP 93 rub9, 818
Date of introduction 2010−09−01
Preface
The objectives and principles of standardization in the Russian Federation established by the Federal law of 27 December 2002 N 184-FZ «On technical regulation», and rules for the application of national standards of the Russian Federation — GOST R 1.0−2004"Standardization in the Russian Federation. The main provisions"
Data on standard
1 PREPARED by Federal State unitary enterprise «Central research Institute of ferrous metallurgy them. I. P. Bardin» (FSUE «tsniichermet im. I. P. Bardina») on the basis of their own authentic translation of the standard referred to in paragraph 4
2 SUBMITTED by the Technical Committee for standardization TC 453 «Implants in surgery"
3 APPROVED AND put INTO EFFECT by the Federal Agency for technical regulation and Metrology of December 11, 2009 N 714-article.
4 this standard is identical with ISO 5832−12:2007 «Implants for surgery. The metallic materials. Part 12. The wrought cobalt alloy, alloyed with chromium and molybdenum» (ISO 5832−12:2007 «Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy»).
In applying this standard it is recommended to use instead of the referenced international standards corresponding national standards of the Russian Federation, details of which are given in Appendix A
5 INTRODUCED FOR THE FIRST TIME
Information about the changes to this standard is published in the annually issued reference index «National standards», and the text changes and amendments — in monthly indexes published information «National standards». In case of revision (replacement) or cancellation of this standard a notification will be published in a monthly information index «National standards». Relevant information, notification and lyrics are also posted in the information system of General use — on the official website of the Federal Agency for technical regulation and Metrology on the Internet
1 Scope
This standard specifies requirements for wrought alloy of two compositions based on cobalt containing 28% chromium and 6% molybdenum, used for the manufacture of surgical implants. Properties specified in relation to a deformable high-quality hire, rod and wire.
Notes
1 Mechanical properties of a sample of the finished products of this alloy may differ from those specified in this standard.
2. High carbon content in this alloy leads to the appearance of significant amounts of carbides in its structure. This amount can be adjusted each time in the manufacture of hire or subsequent thermomechanical processing of the final product. The number of carbides in final products and this standard is not specified.
2 Normative references
This standard uses the regulatory references to the following international standards:
ISO 643* Steel. Metallographic method of determination of the apparent grain size
ISO 6892 Metallic materials. Tensile test at ambient temperature
_______________
* For undated references, use the latest valid edition.
3 Chemical composition
Chemical compositions of the alloy, determined in accordance with section 6 shall conform to those given in table 1.
Table 1 — Chemical composition
| Item | Mass fraction, % | |
| Alloy composition 1 with a low carbon content |
The alloy of the composition 2 with a high carbon content | |
| Chrome |
26,0−30,0 | 26,0−30,0 |
| Molybdenum |
Of 5.0−7.0 | Of 5.0−7.0 |
| Iron |
Not more than 0.75 | Not more than 0.75 |
| Manganese |
Not more than 1.0 | Not more than 1.0 |
| Silicon |
Not more than 1.0 | Not more than 1.0 |
| Carbon |
Not more than 0,14 | 0,15−0,35 |
| Nickel |
Not more than 1.0 | Not more than 1.0 |
| Nitrogen |
Not more than 0.25 | Not more than 0.25 |
| Cobalt |
Basis | Basis |
4 Microstructure
The microstructure of the alloy must be homogeneous. The grain size determined in accordance with section 6, must not be larger than 5-th number.
5 Mechanical properties
The properties of the alloy tensile tested in accordance with section 6 shall conform to the standards given in table 2.
Table 2 — Mechanical properties
| Condition | The tensile strength |
The yield stress |
Elongation |
| not less than | |||
| Heat-treated* |
897 | 517 | 20 |
| Hot |
1000 | 700 | 12 |
| Warm |
1192 | 827 | 12 |
| * Heat treatment method chosen by the manufacturer to achieve the required properties. | |||
(6 test Methods
The test methods used for determining compliance with the requirements of this standard given in table 3.
Table 3 — test Methods
| Requirements |
Standard section | Test method |
| Chemical composition | 3 | Accepted analytical methodologies (ISO methods, if any) |
| Grain size |
4 | ISO 643 |
| Mechanical properties |
5 | ISO 6892 |
Annex a (mandatory). Data on compliance with national standards of the Russian Federation the reference to international standards
Appendix A
(required)
Table A. 1
| Marking the reference international standard |
Designation and name of the relevant national standard |
| ISO 643 |
* |
| ISO 6892 | GOST 1497−84 (ISO 6892−84) Metals. Test methods tensile |
| GOST 10006−80 (ISO 6892−84) of the Pipe metal. Test method tensile | |
| GOST 10446−80 (ISO 6892−84) Wire. Test method tensile | |
| * The corresponding national standard is missing. Prior to its adoption, it is recommended to use the translation into Russian language of this international standard. The translation of this international standard is the Federal information Fund of standards. | |
