GOST R ISO 5832-11-2014
GOST R ISO 5832−11−2014 Implants for surgery. Metallic materials. Part 11. A deformable titanium alloy containing 6-aluminum 7-niobium
GOST R ISO 5832−11−2014
NATIONAL STANDARD OF THE RUSSIAN FEDERATION
IMPLANTS FOR SURGERY
METAL MATERIALS
Part 11
A deformable titanium alloy containing 6-aluminum 7-niobium
Implants for surgery. Metallic materials. Part 11: Wrought titanium 6-aluminum 7-niobium alloy
ACS 11.040.30 *
_____________________
* In IES No. 10 2015 GOST R ISO 5832−11−2014 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 ENABLED The Order of the Federal Agency for Technical Regulation and Metrology of December 12, 2014 No. 2074-st
4 This standard is identical to the international standard ISO 5832−11: 1994 * «Implants for surgery — Metallic materials — Part 11: Deformable titanium alloy containing 6-aluminum 7-niobium» (ISO 5832−11: 1994 «Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminum 7-niobium alloy «)
________________
* 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 annex DA *.
________________
* Probably the error of the original. You should read: YES. — Note of the database manufacturer.
5 INTRODUCED FOR THE FIRST TIME
The rules for the application of this standard are set out in GOST R 1.0−2012 (section 8). The 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 information index «National Standards». In case of revision (replacement) or cancellation of this standard, the relevant notice will be published in the next issue of the 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)
Introduction
None of the known implantation materials used in surgery has demonstrated a complete lack of ability to cause unwanted reactions in the human body. Nevertheless, the long clinical experience of using the material mentioned in this part of ISO 5832 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
This part of ISO 5832 specifies the characteristics and appropriate testing methods for a deformable titanium alloy, known as the titanium alloy 6-aluminum 7-niobium (titanium-6-Al-7-Nb) titanium alloy for use in the manufacture of surgical implants.
NOTE 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 part of ISO 5832.
2 Normative references
This standard uses a normative reference to the following standard *:
_______________
* 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.)
Publication of ETTC 2, Microstructural standards for titanium alloy bars
, 1979. (Publication ETTC 2,
Microstructural Standards for
, 1979).
________________European Technical Committee of Manufacturers of Titanium Products (ETTC).
In stock:
3 Chemical composition
The chemical composition of the melting must meet the requirements for the chemical composition indicated in Table 1. The analysis of the ingot can be used to identify all the mandatory chemical components, with the exception of hydrogen, which will be determined after heat treatment and etching.
Table 1
| Element | Limit values of component content % (mol / mol) |
| Aluminum | from 5.5 to 6.5 |
| Niobium | from 6.5 to 7.5 |
| Tantalum | maximum 0.50 |
| Iron | maximum 0.25 |
| Oxygen | maximum 0.20 |
| Carbon | maximum of 0.08 |
| Nitrogen | maximum of 0.05 |
| Hydrogen | maximum 0,009 |
| Titanium | The rest of |
4 Microstructure
In the study according to Table 3, the microstructure consists of the alpha and beta components and corresponds to the photomicrographs A1 to A9 in the ETTC 2 publication for the annealed material.
5 Mechanical properties
The tensile strength of the alloy, determined in accordance with Article 6, shall comply with the requirements specified in Table 2.
Table 2 — Mechanical properties of the alloy in the annealed state
| Alloy Shape | Strength limit min., MPa | Maximum stress with a disproportionate elongation of min., MPa |
Relative elongation min.,% | Area reduction min.,% |
Bar |
900 | 800 | 10 | 25 |
| ||||
In the event that any of the test fragments do not meet the specified requirements or are broken outside the limits of the scale of the measuring device, two more fragments representative for the same lot are likewise tested. The alloy should be considered suitable only if both additional fragments meet the specified requirements.
If one of the additional fragments does not meet the requirements, then the submitted product must be recognized as not meeting the requirements of this part of ISO 5832.
However, the manufacturer, if desired, may re-heat the material and re-submit it for testing in accordance with the requirements of this part of ISO 5832.
6 Test methods
The test methods to be used to determine compliance with the requirements of this part of ISO 5832 are shown in Table 3.
Representative test pieces for the determination of mechanical properties shall be prepared in accordance with the provisions of ISO 6892.
Table 3 — Test methods
| Demand | Relevant Article |
Test methods |
| Chemical composition | 3 | Commonly recognized analysis procedures (ISO methods, if any) |
| Microstructure | 4 | ETTC 2 |
| Mechanical properties | 5 | |
| Strength limit | ISO 6892 | |
| Maximum stress with a disproportionate elongation |
ISO 6892 | |
| Relative extension | ISO 6892 | |
| Reduced area | ISO 6892 |
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
| Designation of the reference international standard |
Degree of conformity | The designation and name of the relevant national standard |
| ISO 6892: 1984 |
- | * |
| * There is no corresponding national standard. Prior to its approval, it is recommended to use the translation into Russian of this international standard. Translation of this international standard is in the Federal Information Fund of Technical Regulations and Standards. | ||
