GOST R ISO 5832-9-2009

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  ГОСТ Р ИСО 5832-9-2009

GOST R ISO 5832−9-2009 Implants for surgery. The metallic materials. Part 9. Corrosion-resistant (stainless) wrought high nitrogen content

GOST R ISO 5832−9-2009

Group В32
B33
B34
В74

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

IMPLANTS FOR SURGERY. METALLIC MATERIALS

Part 9

Corrosion-resistant (stainless) wrought high nitrogen content

Implants for surgery. Metallic materials. Part 9. Wrought high nitrogen stainless steel

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 713-St

4 this standard is identical to international standard ISO 5832−9:2007 «Implants for surgery. The metallic materials. Part 9. Steel stainless steel wrought high nitrogen content» (ISO 5832−9:2007 «Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel»)

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 of rolled deformed corrosion resistant (stainless) steel with a mass fraction of nitrogen from 0.25% to 0.50% for the manufacture of surgical implants with high strength and corrosion resistance.

Notes

1 Mechanical properties of a sample of a finished product of the steel may differ from those specified in this standard.

2 Requirements to other stainless steels for surgical implants, see ISO 5832−1.

2 Normative references

This standard uses the regulatory references to the following standards:

ISO 377 Steel and steel products. Location and preparation of test specimens for specific mechanical tests

ISO 404:1992 Steel and steel products. General technical delivery conditions

ISO 437 Steel and cast iron. Determination of total carbon content. Gravimetric method-combustion of the sample

ISO 439 Steel and iron. Determination of total silicon content. Gravimetric method

ISO 629 Steel and cast iron. Determination of manganese. Spectrophotometric method

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

ISO 671 Steel and cast iron. The determination of the sulfur content. Titrimetric method with combustion of the sample

ISO 3651−2 Determination of resistance to intergranular corrosion of stainless steels. Part 2. Ferritic, austenitic and ferrite-austenite (two-phase) steel. Corrosion test in media containing sulfuric acid

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

ISO 5832−1 Implants for surgery. The metallic materials. Part 1. Wrought stainless steel

ISO 6892 Metallic materials. Tensile test at ambient temperature

ISO 10714 Steel and iron. The determination of phosphorus. Spectrophotometric method with the use of molybdate of postanawia

Note: For undated references, use the latest valid edition.

3 Chemical composition

3.1 Samples for research

Selection of samples for analyses should be conducted in accordance with the requirements of ISO 377.

3.2 Chemical composition of melting

Chemical analyses of steel heats, determined in accordance with section 6 shall conform to the composition specified in table 1.


Table 1 — Chemical composition

4 Microstructure in the heat treated* condition

________________
* Heat treatment method chosen by the manufacturer to achieve the required properties.

4.1 grain Size

Austenitic grain, as determined in accordance with section 7, must not be larger than 4-th number.

4.2 the Absence of Delta-ferrite

When examined in accordance with table 6 in the microstructure of steel should not be Delta-ferrite.

4.3 Evaluation of inclusions

Pollution steel non-metallic inclusions determined in accordance with section 7, the characteristic of the workpiece or on samples of hot-rolled steel of a thickness not exceeding 150 mm shall not exceed the values given in table 2.

Note — Usually, in practice, the steel after electroslag remelting, having the desired purity of the metal impurities and other additional benefits.


Table 2 — Norms of pollution particles

5 Corrosion resistance

Steel must be resistant to intergranular corrosion when tested according to the method of Monypenny-Strauss in accordance with section 7 after pre-heating the test sample at a temperature of 675 °C for 1 h and air cooling.

6 Mechanical properties

The properties of steel depending on the type of steel in the tensile test in accordance with section 7 shall conform to the requirements of tables 3, 4, or 5.


Table 3 — Mechanical properties of rolled

Table 4 — Mechanical properties of wire and bar

Table 5 — Mechanical properties of thin sheet and strip

If one of the test specimens does not meet the requirements or is destroyed beyond the calculated length of a specimen, carried out repeated testing in compliance with the requirements of ISO 404 (section 8.4.3.4).

7 test Methods

Test methods for determining compliance with the requirements of this standard are given in table 6.


Table 6 — test Methods

Selection and preparation of samples for tensile testing shall conform to the requirements of ISO 377.

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

Appendix A
(required)