GOST R ISO 5832-6-2010
GOST R ISO 5832−6-2010 Implants for surgery. The metallic materials. Part 6. Alloy cobalt-Nickel-chromium-molybdenum wrought
GOST R ISO 5832−6-2010
Group В32
NATIONAL STANDARD OF THE RUSSIAN FEDERATION
IMPLANTS FOR SURGERY. METALLIC MATERIALS
Part 6
Alloy cobalt-Nickel-chromium-molybdenum wrought
Implants for surgery. Metallic materials. Part 6. Wrought cobalt-nickel-chromium-molybdenum 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 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 dated November 12, 2010 N 392-St
4 this standard is identical to international standard ISO 5832−6:1997* «Implants for surgery. The metallic materials. Part 6, «alloys based on cobalt, Nickel, chromium, and molybdenum» (ISO 5832−6:1997 «Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy»)
________________
* Access to international and foreign documents referred to here and hereinafter, can be obtained by clicking on the link. — 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 specifies performance requirements and test methods for deformable cobalt-Nickel-chromium-molybdenum alloy, intended for the manufacture of surgical implants.
Note — the Mechanical properties of the alloy obtained on samples of finished products may differ from those specified in this standard.
2 Normative references
The present standard features references to the following standards*:
_______________
* The table of conformity of national standards international see the link. — Note the manufacturer’s database.
ISO 643 Steel. Metallographic method of determination of the apparent grain size
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 |
33,0−37,0 |
| Chrome |
19,0−21,0 |
| Molybdenum |
9,0−10,5 |
| Iron |
Not more than 1.0 |
| Titan |
Not more than 1.0 |
| Manganese |
Not more than 0.15 |
| Silicon |
Not more than 0.15 |
| Carbon |
0.025 |
| Phosphorus |
Not more than 0,015 |
| Sulfur |
Not more than 0,010 |
| Cobalt |
Basis |
4 Microstructure
The microstructure of the alloy must be homogeneous. Grain size, determined in accordance with section 6, must not be larger than 4-th number.
5 Mechanical properties
The properties of the alloy in tension, determined in accordance with section 6 shall conform to the requirements of table 2.
Table 2 — Mechanical properties
| Condition | Tensile strength |
Yield strength |
Elongation* |
| not less than | |||
| Heat-treated** |
800 | 300 | 40 |
| Medium hardness |
1000 | 650 | 20 |
| Solid |
1200 | 1000 | 10 |
* Calculated length | |||
, MPa
, MPa
or 50 mm, where
Notes
1 Mechanical properties of the material can be changed by cold deformation or cold deformation with subsequent aging.
If one of the test specimens does not meet the requirements or is destroyed beyond its design length, a second test of the two samples are again selected from the same batch. The alloy is considered to have passed the test if both results match the specified requirements.
2 are permitted by the manufacturer re-heat treatment and subsequent testing in accordance with the requirements of this standard.
6 test Methods
Test methods for determination of the requirements of this standard are given in table 3.
Preparation of samples for investigation of mechanical properties carried out in accordance with ISO 6892.
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 |
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 corre- tion |
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. The translation of this international standard is the Federal information Fund of technical regulations and standards. Note — In this table used the symbol of compliance of the standards: MOD — modified standard. | ||
