GOST R ISO 5832-3-2014

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  ГОСТ Р ИСО 5832-3-2014

GOST R ISO 5832−3-2014 Implants for surgery. Metallic materials. Part 3. Deformable alloy based on titanium, 6-aluminum and 4-vanadium (with Amendment)

GOST R ISO 5832−3-2014

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

IMPLANTS FOR SURGERY

METAL MATERIALS

Part 3

Deformable alloy based on titanium, 6-aluminum and 4-vanadium

Implants for surgery. Metallic materials. Part 3: Wrought titanium 6-aluminum 4-vanadium alloy

ACS 11.040.30 *

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* In IES No. 10 2015 GOST R ISO 5832−3-2014 is given with ACS 11.040.40,

here and below. — Note of the database manufacturer.

Date of implementation 2016−01−01

Foreword

1 PREPARED BY Limited Liability Company «CITOPROJECT» (LLC «CITOPROJECT») on the basis of its own authentic translation into Russian of the international standard specified in clause 4

2 was introduced by the Technical Committee for Standardization of TC 453 «Implants in Surgery»

3 APPROVED AND ENTRY INTO FORCE The Order of the Federal Agency for Technical Regulation and Metrology of December 12, 2014 No. 2061-ст

4 This standard is identical to the international standard ISO 5832−3: 1996 * «Implants for surgery — Metallic materials — Part 3: Deformable alloy based on titanium, 6-aluminum and 4-vanadium» (ISO 5832−3: 1996 «Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminum 4-vanadium alloy «)
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* Access to international and foreign documents, mentioned here and below in the text, can be obtained by clicking on the link to the site shop.cntd.ru. — Note of the database manufacturer.

When applying this standard, it is recommended to use the corresponding national standards of the Russian Federation in place of the reference international standards, the details of which are given in the supplementary Appendix YES

5 INTRODUCED FOR THE FIRST TIME

The rules of application of this standard are set in GOST R 1.0−2012 (section 8). Information on changes to this standard is published in the annual (as of January 1 of the current year) information index «National Standards», and the official text of the amendments and amendments is published in the monthly index «National Standards». In case of revision (replacement) or cancellation of this standard, a corresponding notice will be published in the next issue of the monthly information index «National Standards». The relevant information, notification and texts are also posted in the public information system — on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet (gost.ru)

The amendment published in IMS No. 6, 2017

The amendment was made by the database manufacturer

Introduction

None of the known implantation materials used in surgery has demonstrated an absolute lack of ability to cause unwanted reactions in the human body. However, long-term clinical experience with the use of the material mentioned in this standard has demonstrated that with the use of this material, if it is properly applied, an acceptable level of biological response can be expected.

1 area of use

The present standard specifies characteristics and appropriate test methods for a deformable titanium alloy, known as the titanium alloy of 6-aluminum 4-vanadium (Ti-6-AI-4-V alloy) intended for use in the manufacture of surgical implants.

(Amendment IES No. 6−2017).

NOTE 1 The mechanical properties of a sample obtained from a finished product made from this alloy do not necessarily coincide with the characteristics specified in this standard

2 Normative references

Normative references to the following standards are used in this standard: *
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* Refer to the table of compliance of national standards with international standards. — Note of the database manufacturer.

ISO 6892: 1984 Metallic materials. Tensile test. (ISO 6892: 1984, Metallic materials — Tensile testing.)

ISO 7438: 1985 Metallic materials. Bending test. (ISO 7438: 1985, Metallic materials — Bend test.)

ETTC * Publication 2, 1979, Microstructural Standards for Titanium Alloy Bars + ** (ETTU Publication 2, 1979, Microstructural standards for + titanium alloy bars **)
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* European Technical Committee of Manufacturers of Titanium Products (ETTS).

** Available for sale: Deutsche Titan GmbH, Essen, Germany (Essen, Germany) and IMI-Titanium Ltd., Birmingham, UK (Birmingham, United Kingdom). This information is provided for the convenience of users of this part of ISO 5832 and does not indicate the support of these products by the International Organization for Standardization.

3 Chemical composition

The results of the analysis of a representative sample of the alloy melting / ingot in determining the composition in accordance with section 6 should correspond to the chemical composition indicated in Table 1.

NOTE 2 Analysis of the ingot can be used to determine all chemical elements, except hydrogen.

The analysis of the hydrogen content should be carried out after the final heat treatment and final surface treatment.

The requirements for the content of the main and minor components of the alloy based on titanium, 6-aluminum and 4-vanadium are listed in Table 1.


Table 1 Chemical composition

4 Microstructure

In the study according to Table 3, the microstructure should be alpha + beta globular and correspond to the photomicrographs A1 to A9 in publication 2 of the ETTS for the annealed material.

5 Mechanical properties

5.1 Stretching

The mechanical properties of the alloy when stretched during the test in accordance with paragraph 6 shall comply with the values indicated in Table 2.

In the event that any of the test samples does not meet the specified requirements or is destroyed beyond the limit values, two more samples representative for the same batch are likewise tested in the same way. The alloy will be considered suitable only if both additional samples meet the specified requirements.

Table 2 — Mechanical properties of a deformable alloy based on titanium, 6-aluminum and 4-vanadium in the annealed state

NOTE 3 — However, the manufacturer may subject the material to a re-heat treatment and re-submit it for testing in accordance with this part of ISO 5832. In this case, all parts shall be heat treated in the same manner.

5.2 Properties for bending

The sheets and strips of the titanium alloy, when tested in accordance with the instructions in Section 6, shall not have cracks on the outer surface of the test specimen.

6 Test methods

The test methods to be used to determine compliance with the requirements of this standard are given in Table 3.

Representative test specimens for determining mechanical properties should be prepared in accordance with the provisions of [1].


Table 3 — Test methods

Appendix YES (informative). Information on the Compliance of Reference International Standards with the National Standards of the Russian Federation

Appendix YES
(reference)

Table YES.1

Bibliography