GOST R ISO 5832-2-2014

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  ГОСТ Р ИСО 5832-2-2014

GOST R ISO 5832−2-2014 Implants for surgery. The metallic materials. Part 2. Non-alloy titanium

GOST R ISO 5832−2-2014

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

IMPLANTS FOR SURGERY

METALLIC MATERIALS

Part 2

Non-alloy titanium

Implants for surgery. Metallic materials. Part 2. Unalloyed titanium

OKS 11.040.30*

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* ICS N 10 2015 GOST R ISO 5832−2-2014 is with ACS 11.040.40,

here and further. — Note the manufacturer’s database.

Date of introduction 2016−01−01

Preface

1 PREPARED by limited liability company «Cytoproct» (LLC «Cytoproct») on the basis of their own authentic translation into the Russian language of the international standard indicated 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 12, 2014 N 2060-St

4 this standard is identical to international standard ISO 5832−2:1999* «Implants for surgery. The metallic materials. Part 2. Non-alloy titanium» (ISO 5832−2:1999 «Implants for surgery — Metallic materials — Part 2: Unalloyed titanium»)
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* Access to international and foreign documents referred to here and hereinafter, can be obtained by clicking on the link to the site shop.cntd.ru. — Note the manufacturer’s database.

In applying this standard it is recommended to use instead of the referenced international standards corresponding national standards of the Russian Federation, details of which are given in Appendix YES

5 INTRODUCED FOR THE FIRST TIME

Application rules of this standard are established in GOST R 1.0−2012 (section 8). Information about the changes to this standard is published in the annual (as of January 1 of the current year) reference index «National standards» and the official text changes and amendments — in monthly formational index «National standards». In case of revision (replacement) or cancellation of this standard a notification will be published in the upcoming issue of the 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 (gost.ru)

Introduction

None of the known implant materials used in surgery have not demonstrated an absolute lack of ability to cause adverse reactions in the human body. However, long-term clinical experience with the use of material referred to in this standard has demonstrated that with the use of this material subject to its proper application it is possible to expect an acceptable level of biological response.

1 Scope

This standard specifies the characteristics and relevant test methods for unalloyed titanium designed for use in the manufacture of surgical implants.

The position of the six grades of titanium, allocated depending on the tensile strength (see table 2).

Note — the Mechanical properties of the sample obtained from a finished product made from this metal do not necessarily coincide with the characteristics specified in this standard.

2 Normative references

The present standard features references to the following standards*:
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* The table of conformity of national standards international see the link. — Note the manufacturer’s database.

ISO 6892:1998 metallic Materials. Tensile test at ambient temperature. (ISO 6892:1998, Metallic materials — Tensile testing at ambient temperature.)

ISO 7438: metallic Materials-1995. The bending test. (ISO 7438:1995, Metallic materials — Bend test)

ASTM E 112:1988 Standard test methods for determining average grain size (ASTM E 112:1988, Standard Test Methods for Determining Average Grain Size)

3 Chemical composition

Chemical composition of melting determined in accordance with section 6 shall conform to the requirements of chemical composition specified in table 1. Analysis of the ingot can be used to identify all the required chemical components, with the exception of hydrogen, which will be determined after heat treatment and decamerone.

4 Microstructure

Microscopic structure of titanium in the annealed condition should be uniform. The grain size determined in accordance with the instructions in section 6, should not larger than the N 5.

At a magnification of 100 times should not be detected on or extraneous phase.

5 Mechanical properties

5.1 Mechanical properties tensile

The strength of the titanium in tension, determined in accordance with 6 must meet the requirements specified in table 2.

In that case, if any test specimens fails to meet the requirements, similarly still have two samples representative of the same party. Titanium is considered suitable only if both additional samples comply with specified requirements. If the specimen was destroyed in the limits, the test is unreliable, and conducted a second test.

If any repeat tests are not able to meet the relevant requirements, the submitted product must be recognized as not meeting the requirements of this standard. However, the manufacturer may re-subjecting the material to heat treatment and re-submit it for testing in accordance with the requirements of this standard.

5.2 Mechanical properties in bending

Sheets and strip of titanium during the tests specified in section 6 shall not have cracks on the outer surface of the test sample.


Table 1 — Chemical composition

Table 2 — Mechanical properties

6 test Methods

Test methods that will be used to determine compliance with the requirements of this standard is given in table 3.

Representative test specimens for determining mechanical properties shall be prepared in accordance with the provisions of ISO 6892.


Table 3 — test Methods

App YES (reference). Information about the compliance of the referenced international standards national standards of the Russian Federation

App YES
(reference)

Table YES.1