GOST R ISO 5832-5-2010

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  ГОСТ Р ИСО 5832-5-2010

GOST R ISO 5832−5-2010 Implants for surgery. The metallic materials. Part 5. The alloy cobalt-chromium-tungsten-Nickel wrought

GOST R ISO 5832−5-2010

Group В32

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

IMPLANTS FOR SURGERY. METALLIC MATERIALS

Part 5

The alloy cobalt-chromium-tungsten-Nickel wrought

Implants for surgery. Metallic materials. Part 5. Wrought cobalt-chromium-tungsten-nickel 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 394-St

4 this standard is identical to international standard ISO 5832−5:2005* «Implants for surgery. The metallic materials. Part 5. Alloys based on cobalt, chromium, tungsten and Nickel» (ISO 5832−5:2005 «Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel 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 specifies performance requirements and test methods for deformable cobalt-chromium-tungsten-Nickel alloy 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

This standard uses the regulatory references to the following standards:

ISO 643 Steel. Metallographic method of determination of the apparent grain size

ISO 4967:1998 Steel. Determination of content of nonmetallic inclusions. Metallographic method using standard diagrams

ISO 6892 Metallic materials. Tensile test at ambient temperature

3 Chemical composition

The chemical composition of the samples of the alloy, determined in accordance with section 6 shall conform to the composition given in table 1.


Table 1 — Chemical composition

4 Microstructure

4.1 grain Size

The samples for investigation must be prepared and etched using any agreed method. Grain size, determined in accordance with ISO 643, should not be larger than 5-th number.

Note — reference to ISO 643 despite the fact that specified in this standard, refers to the alloy materials based on iron.

4.2 non-metallic inclusions

Evaluation of inclusions should be carried out on thin sections with a longitudinal direction of the fiber in accordance with the requirements of ISO 4967 method A.

Contamination of alloy, non-metallic inclusions shall not exceed the limits given in table 2.


Table 2 — Norms of contamination of alloy, non-metallic inclusions

5 Mechanical properties

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


Table 3 — Mechanical properties

The mechanical properties of the alloy otherwise than in heat-treated condition must be specified by the consumer in the order.

6 test Methods

Test methods for determination of the requirements of this standard are given in table 4.

Preparation of samples for investigation of mechanical properties carried out in accordance with ISO 6892.


Table 4 — test Methods

App. 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