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GOST R ISO 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*

_____________________

* 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*:
________________
* 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

Item
The maximum limit value of the content, mass fraction, %
Grade 1 ELI Grade 1 Grade 2 Grade S Grade 4A and 4B
Nitrogen
0,012 0,03 0,03 0,05 0,05
Carbon
0,03 0,10 0,10 0,10 0,10
Hydrogen

0,0125ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титан

0,0125ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титан

0,0125ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титан

0,0125ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титан

0,0125ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титан

Iron
0,10 0,20 0,30 0,30 0,50
Oxygen
0,10 0,18 0,25 0,35 0,40
Titan
The rest The rest The rest The rest The rest

ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титанExcept for bullion, for which the maximum content of hydrogen should be 0,010 0% (mass fraction) and flat products for which a maximum hydrogen content of 0.015% (mass fraction)



Table 2 — Mechanical properties

Grade Conditions

Tensile strengthГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титан, MPa, not less

Yield strength at disproportionate elongation, MPa, not less

ElongationГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титан, %, not less

The mandrel diameter for bend test for sheets and stripsГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титан, mm

tГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титан2 mm

2 mm<<em>t<5 mm
1 ELI Annealed
200 140 30 3t 4t
1 Annealed
240 170 24 3t 4t
2 Annealed
345 275 20 4t 5t
3 Annealed
450 380 18 4t 5t
4A Annealed
550 483 15 5t 6t
4B Deformed in a cold state
680 520 10 6t 6t

ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титанRequirements for tensile, plastic deformation and Flexural properties for the sheet applicable to the material, taken as parallel and perpendicular to the direction of rolling.

ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титанSample length=5,65ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титанmm or 50 mm, where SГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титанis the original cross-sectional area in square millimeters.

ГОСТ Р ИСО 5832-2-2014 Имплантаты для хирургии. Металлические материалы. Часть 2. Нелегированный титанt=the thickness of the sheet or strip.

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

Requirement
Appropriate section Test method
Chemical composition
3 The conventional analysis procedures
The grain size
4 ASTM E 112
Mechanical properties

The limit of tensile strength

Yield strength

Elongation

The reduction in the area

The bend test
5

ISO 6892

ISO 6892

ISO 6892

ISO 6892

ISO 7438 Bend the sheet or strip at an angle not less than 105° around the snap, the diameter of which is shown in table 2

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

App YES
(reference)


Table YES.1

Marking the reference international standard
The degree of compliance Designation and name of the relevant national standard
ISO 6892:1998 - *
ISO 7438:1995 IDT GOST 14019−2003 (ISO 7438:1985) Materials of metal. Method of bend test.
ASTM E 112:1988 - *
*The corresponding national standard is missing. Prior to its adoption, it is recommended to use the translation into Russian language of this international standard. The translation of this international standard is the Federal information Fund of technical regulations and standards.

Note — In this table used the symbol of the degree of compliance of the standard:

— IDT — identical standards.