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GB 23102-2008: Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy
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| GB 23102-2008 | English | 114 |
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Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy
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GB 23102-2008
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Basic data | Standard ID | GB 23102-2008 (GB23102-2008) | | Description (Translated English) | Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy | | Sector / Industry | National Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 6,648 | | Date of Issue | 2008-12-30 | | Date of Implementation | 2010-03-01 | | Quoted Standard | GB/T 228; ETTC 2-1979 | | Adopted Standard | ISO 5832-11-1994, IDT | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 26 of 2008 (total 139) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Chinese standard specifies the surgical implant alloy Ti-6Al-7Nb processing material properties and the corresponding test methods. | GB 23102-2008: Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for surgery.Metallic materials.Wrought titanium -6aluminium-7niobium alloy
ICS 11.040.40
C35
National Standards of People's Republic of China
GB 23102-2008/ISO 5832-11.1994
The surgical implant of a metal material
(ISO 5832-11.1994, Implantsforsurgery-Metalicmaterials-
Part 11. Wroughttitanium6-aluminium7-niobiumaloy, IDT)
Published 2008-12-30
2010-03-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China issued
Foreword
All technical contents of this standard is mandatory.
Using the equivalent standards ISO 5832-11.1994 "metallic surgical implant materials - Part 11. Ti-6Al-7Nb alloy was added
Workers material. "
For ease of use, the standard of the original international standard made the following editorial changes.
a) delete the foreword international standards;
b) delete the introduction of international standards.
Appendix A of this standard is normative.
This standard was proposed by the State Food and Drug Administration.
This standard by the National Surgical implants and orthopedic devices Standardization Technical Committee (SAC/TC110).
Drafted. There is research billion of new materials Co., Ltd., Beijing Nonferrous Metal Research Institute, Baoji Nonferrous Metals Processing Factory.
The main drafters. Miao Weidong, Yuan Zhi Shan, Wang Jiangbo, Feng Zhaowei, Liu Wei, Ye Wenjun, Song Xiao Hui, rice Xu Jun, Wang Guisheng,
Huang Yongguang, Li Xianjun, Zhang Pinghui.
GB 23102-2008/ISO 5832-11.1994
The surgical implant of a metal material
Range 1
This standard specifies the properties of an alloy with a processing material Ti-6Al-7Nb and the corresponding test methods surgical implant.
Note 1. The sample is taken from the finished product, the mechanical properties may not necessarily comply with the rules of this standard.
2 Normative references
Terms of the following documents become provisions of this standard by reference in this standard. For dated reference documents, all later
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to agreements based on this standard
Whether the latest versions of these documents. For undated references, the latest version applies to this standard.
GB/T 228 materials at ambient temperature tensile test method (GB/T 228-2002, eqv ISO 6892.1998)
ETTC2. 1979 (α + β) microstructure of two-phase titanium alloy bars standard
3 Chemical composition
Melting analysis should meet the requirements of detecting chemical composition, the chemical composition of the product should meet the requirements of Table 1. In addition to hydrogen in the heat treatment
Pickling and outer test, other elements may be employed ingot analysis.
Table 1 chemical composition of the product
Elemental composition range /% (mass fraction)
Aluminum (Al)
Niobium (Nb)
Tantalum (Ta)
Iron (Fe)
Oxygen (O)
Carbon (C)
Nitrogen (N)
Hydrogen (H)
Titanium (Ti)
5.5 to 6.5
6.5 to 7.5
≤0.50
≤0.25
≤0.20
≤0.08
≤0.05
≤0.009
Matrix
4 microstructure
When tested according to the method of Table 3, the transverse annealed microstructure α + β should be processed tissue, assessed in Appendix A, the type of tissue which should meet
Graph A. 1 to A. 9.
5 Mechanical Properties
When tested by the method in Chapter 6, the mechanical properties shall comply with the provisions of Table 2.
GB 23102-2008/ISO 5832-11.1994
Table 2 Mechanical Properties of Annealed
State Tensile strength Rm/MPa
Non-proportional extension strength Rp0.2 /
MPa
Elongation A /
Reduction of Z /
Bar a ≥900 ≥800 ≥10 ≥25
a diameter or thickness ≤100mm.
If the test results of a sample from the defective or broken in an outer standard, should be the same batch of products Another two samples retest. complex
Test samples were satisfactory, the penalty whole batch of qualified products. Ruofu still failed test sample case, this batch of product failure. base on needs,
Production of heat-treated before reuse or resampling.
6 Test methods
Test methods should be consistent with the provisions in Table 3. Sample processing shall comply with GB/T 228 a.
Table 3 Test Method
Test items related clauses testing methods
Chemical composition 3
Accepted analytical methods (existing ISO or national standard method
Recommended method)
Microstructure 4 ETTC2
Mechanical Properties
tensile strength
Non-proportional extension strength
Elongation
rate of reduction in area
GB/T 228
GB/T 228
GB/T 228
GB/T 228
GB 23102-2008/ISO 5832-11.1994
Appendix A
(Normative)
ETTC2, (α + β) microstructure of two-phase titanium alloy standards diagrams (annealed) (FIG A.1 ~ FIG A.12)
Figure A. FIG 1 × 200 A. 2 × 200
Figure A. FIG 3 × 200 A. 4 × 200
Figure A. FIG 5 × 200 A. 6 × 200
GB 23102-2008/ISO 5832-11.1994
Book GB 23102-2008/ISO 5832-11.1994
Figure A. 7 × 200
Figure A. 8 × 200
Figure A. 9 × 200
Figure A. 10 × 200
Figure A. 11 × 200
Figure A. 12 × 200
4991.
11-
OSI/8002-
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