GOST R ISO 5832-8-2010
GOST R ISO 5832−8-2010 Implants for surgery. The metallic materials. Part 8. Alloy cobalt-Nickel-chromium-molybdenum-tungsten containing iron, wrought
GOST R ISO 5832−8-2010
Group В32
NATIONAL STANDARD OF THE RUSSIAN FEDERATION
IMPLANTS FOR SURGERY. METALLIC MATERIALS
Part 8
Alloy cobalt-Nickel-chromium-molybdenum-tungsten containing iron, wrought
Implants for surgery. Metallic materials. Part 8. Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy
OKS 11.040.40
OKP 93 9800
Date of introduction 2011−11−01
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 into the Russian language of the standard specified in item 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 dated November 12, 2010 N 391-St
4 this standard is identical to international standard ISO 5832−8:1997* «Implants for surgery. The metallic materials. Part 8. Alloys based on cobalt, Nickel, chromium, molybdenum, tungsten and iron» (ISO 5832−8:1997 «Implants for surgery — Metallic materials — Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy»)
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* Access to international and foreign documents can be obtained by clicking on the link, here and hereafter. — Note the manufacturer’s database.
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 establishes requirements for wrought cobalt-Nickel-chromium-tungsten alloy containing iron, intended for the manufacture of surgical implants.
Note — the Mechanical properties of the alloy obtained on samples of finished products are dependent on processing and may differ from those specified in this standard.
2 Normative references
This standard uses the regulatory references to the following standards:
ISO 643* Steel. Metallographic method of determination of the apparent grain size
_______________
* Reference is given despite the fact that specified in this standard, the alloy does not apply to materials based on iron.
ISO 6892 Metallic materials. Tensile test at ambient temperature
For undated references, it is recommended that the latest valid edition.
3 Chemical composition
The alloy’s chemical composition by ladle sample, determined in accordance with section 6 shall conform to the composition given in table 1.
Table 1 — Chemical composition
| Item | Mass fraction of elements, % |
| Nickel |
15,0−25,0 |
| Chrome |
18,0−22,0 |
| Molybdenum |
For 3.0−4.0 |
| Tungsten |
For 3.0−4.0 |
| Iron |
4,0−6,0 |
| Titan |
0,5−3,50/0,50−3,50* |
| Carbon |
Not more than 0.05 |
| Manganese |
Not more than 1.0 |
| Silicon |
Not more than 0,50 |
| Sulfur |
Not more than 0,010 |
| Cobalt |
Basis |
| * Denominator indicates the entry was adopted in Russia. | |
4 Microstructure
Microstructurein alloy must be homogeneous and single-phase in heat-treated
* condition. Grain size of heat-treated alloy, as determined in accordance with section 6, must not be larger than 5-th number.
_______________
* The footnoteand the footnote
in the original paper is given in section 6 (table 3). — Note the manufacturer’s database.
5 Mechanical properties
The properties of the alloy in tension, determined in accordance with section 6 shall conform to the requirements of table 2.
Note — the Mechanical properties of this alloy can be modified by cold deformation and cold deformation with subsequent aging.
Table 2 — Mechanical properties
| Condition | Tensile strength |
Yield strength |
Elongation* |
| not less than | |||
| Heat-treated** |
600 | 275 | 50 |
| Cold-formed or cold-drawn and aged |
|||
| Medium hardness |
1000 | 830 | 18 |
| Solid |
1310 | 1170 | 12 |
| High hardness |
1580 | 1310 | 5 |
* Calculated length | |||
MPa
MPa
or 50 mm, where 6 test Methods
Test methods for determination of the requirements of this standard are given in table 3.
Table 3 — test Methods
| Requirements | Standard section |
Test method |
| Chemical composition | 3 | Accepted analytical methodologies (ISO methods, if exist) |
| Grain size |
4 | ISO 643 |
| Mechanical properties |
5 | ISO 6892 |
| ||
1.4 kg/l) + 100 ml of hydrochloric acid (
Preparation of samples for investigation of mechanical properties carried out in accordance with ISO 6892.
Application YES (compulsory). Data on compliance with national standards of the Russian Federation the reference of the international (regional) standards
App YES
(required)
Table YES.1 International standards referenced in this standard and the corresponding national standards
| Marking the reference international standard |
The degree of compliance | Designation and name of the relevant national standard |
| ISO 643 | - | * |
| ISO 6892 | MOD | GOST 1497−84 (ISO 6892−84) «Metals. Methods of tensile tests" GOST 10006−80 (ISO 6892−84) «Pipe metal. Method of tensile test" GOST 10446−80 (ISO 6892−84) «Wire. Method of tensile test" |
| * The corresponding national standard is missing. Prior to its adoption, it is recommended to use the translation into Russian language of this international standard, in Federal information Fund regulations and standards. Note — In this table used the symbol of compliance of the standards: MOD — modified standard. | ||
