GOST R ISO 5832-7-2009

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  ГОСТ Р ИСО 5832-7-2009

GOST R ISO 5832−7-2009 Implants for surgery. The metallic materials. Part 7. The alloy cobalt-chromium-Nickel-molybdenum containing iron, malleable and cold-deformed

GOST R ISO 5832−7-2009

Group В32
В73

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

IMPLANTS FOR SURGERY

METALLIC MATERIALS

Part 7

The alloy cobalt-chromium-Nickel-molybdenum containing iron, malleable and cold-deformed

Implants for surgery. Metallic materials. Part 7. Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron 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 715-St

4 this standard is identical to international standard ISO 5832−7:1994 «Implants for surgery. The metallic materials. Part 7. The alloy is ductile and cold-deformed cobalt, chromium, Nickel, molybdenum and iron» (ISO 5832−7:1994 «Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy»)

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 ductile and cold-deformed iron-containing cobalt-chromium-Nickel-molybdenum alloy, intended for the manufacture of surgical implants.

Note — the Mechanical properties of the sample of the finished products of this alloy may differ from those specified in this standard.

2 Normative references

This standard uses the regulatory references to the following standards:

ISO 643:1983* Steel. Metallographic method for the determination of the ferritic or austenitic grain size

ISO 4967:1979* Steel. Determination of content of nonmetallic inclusions. Metallographic method using standard diagrams

ISO 6892:1984 Metallic materials. Tensile test
_______________
* At the time of publication of ISO 5832−7:1994 these standards were in force. It is recommended to use the latest edition of applicable international standards mentioned above.

3 Chemical composition

Chemical analyses of heats of alloy, determined in accordance with section 6 shall conform to the composition specified in table 1. Chemical analyses of samples of finished products of this alloy also must conform to table 1.


Table 1 — Chemical composition

4 Microstructure

4.1 grain Size

The microstructure must be homogeneous. The grain size determined in accordance with section 6, must not be larger than 5-th number.

4.2 Assessment of inclusions

Contamination of alloy, non-metallic inclusions determined in accordance with section 6, shall not exceed the limits specified in table 2.


Table 2 — Norms of pollution particles

5 Mechanical properties

The mechanical properties of the alloy, determined in accordance with section 6 shall conform to the requirements of table 3.


Table 3 — Mechanical properties

6 test Methods

The test methods used for determining compliance with the requirements of this standard given in table 4.


Table 4 — test Methods

Annex a (mandatory). Data on compliance with national standards of the Russian Federation the reference of the international (regional) standards

Appendix A
(required)

Table A. 1 International standards referenced in this standard and the corresponding national standards