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GB/T 13810-2007 English PDF (GBT13810-2007)

GB/T 13810-2007 English PDF (GBT13810-2007)

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GB/T 13810-2007: Wrought titanium and titanium alloy for surgical implants

This Standard specifies the requirements, test methods, inspection rules and marks, packaging, transport, storage and order (or contact) for wrought titanium, TC4 alloy, TC4ELI alloy, TC20 (Ti-6Al-7Nb) alloy processing materials used for surgical implants.
GB/T 13810-2007
GB
NATIONAL STANDARD OF
THE PEOPLE REPUBLIC OF CHINA
ICS 77.150.50
H 64
Replacing GB/T 13810-1997
Wrought titanium and titanium alloy for surgical implants
ISSUED ON. NOVEMBER 23, 2007
IMPLEMENTED ON. JUNE 1, 2008
Issued by. General Administration of Quality Supervision, Inspection
and Quarantine;
Standardization Administration Committee.
3. No action is required - Full-copy of this standard will be automatically and immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Requirements ... 6
4 Test methods ... 10
5 Inspection rules ... 12
6 Mark, packaging, transport, storage ... 14
7 Order (or contract) content ... 15
Annex A (Normative) Two-phase titanium alloy metallographic classification grading chart (annealing state) ... 16
Annex B (Normative) Flaw-detection method of titanium and titanium alloy sheet Lamb wave ... 18
Foreword
When this Standard was revised, the wrought titanium processing material referred to the International Organization for Standardization ISO
5832-2.1999 (E) Implants for surgery - Metallic materials - Part 2. Unalloyed titanium and ASTM F1472.2002 Wrought Titanium-6 Aluminum-4 Alloy for
Surgical Implant. TC-4 processing material referred to ISO 5832-3.1996 (E) Implants for surgery - Metallic materials - Part 3. Wrought titanium
6-aluminium 4-vanadium alloy and ASTM F1472.2002 Wrought Titanium-6
Aluminum-4 Alloy for Surgical Implant. TC4ELI processing material referred to ASTM F136.2002a Standard Specification for Wrought Titanium-6
Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. TC20 processing material referred to ISO 5832-11.1994 (E) Implants for surgery - Metallic materials - Part 11. Wrought titanium
6-aluminium 7-niobium alloy and ASTM F1295.2005 Standard Specification
for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant
Applications.
The chemical composition and microstructure and other indicators of wrought titanium processing material are identical with the requirements of ISO 5832-2.1999 (E). The mechanical performance indicator is equal to or greater than ISO 5832-2. It added the section shrinkage indicator of bar. Meanwhile, it added the ultrasonic testing requirements for plates and bars.
The chemical composition and microstructure and other indicators of TC4 processing material are identical with the requirements of ISO 5832-3.1996 (E). The mechanical performance requirements are higher than ISO 5832-3. And it added the section shrinkage indicator of bar. Meanwhile, it added the ultrasonic testing requirements for plates and bars.
The chemical composition, mechanical properties and bending properties
and other indicators of TC4ELI are identical with the requirements of ASTM F136.2002a. And it added microstructure rating and ultrasonic testing
requirements for plates and bars.
The chemical composition, mechanical properties and microstructure of TC 20 processing material are identical with the requirements of ISO
5832-11.1994 (E). And it added low magnification testing, ultrasonic testing requirements for bars.
This Standard replaces GB/T 13810-1997 Wrought titanium and titanium
alloy for surgical implants.
Compared with GB/T 13810-1997, the main changes in this Standard are as follows.
Wrought titanium and titanium alloy for surgical implants
1 Scope
This Standard specifies the requirements, test methods, inspection rules and marks, packaging, transport, storage and order (or contact) for wrought titanium, TC4 alloy, TC4ELI alloy, TC20 (Ti-6Al-7Nb) alloy processing
materials used for surgical implants.
This Standard is applicable to titanium and titanium alloy plates, bars, wires used for surgical implants.
2 Normative references
The following standards contain the provisions which, through reference in this Standard, constitute the provisions of this Standard. For dated references, subsequent amendments (excluding corrections) or revisions do not apply to this Standard. However, the parties who enter into agreement based on this Standard are encouraged to investigate whether the latest versions of these documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 228, Metallic materials - Tensile testing
GB/T 232, Metallic materials - Bend test
GB/T 2965, Titanium and titanium alloy bars
GB/T 3620.1, Designation and Composition of Titanium and Titanium
Alloys
GB/T 3620.2, Titanium and titanium alloys - permissible variations of
chemical composition for wrought product analysis
GB/T 3621, Titanium and titanium alloy plate and sheet
GB/T 3623, Titanium and titanium alloy wire
GB/T 4698 (all parts), Sponge titanium, titanium and titanium alloys
GB/T 5168, Microstructure and macrostructure examination for ??-??
titanium alloys
vacuum consumable arc furnace smelting. The smelting must not be less
than twice.
3.2.2 The consumable electrode is forbidden to use TIG welding.
3.3 Chemical composition
The product?€?s chemical composition shall comply with the provisions on
corresponding designation in GB/T 3620.1. Hydrogen content in wrought
titanium, TC4 and TC4ELI shall not exceed 0.010%. When the purchaser
re-inspects, chemical composition tolerance shall comply with GB/T 3620.2. 3.4 Dimension and tolerance
3.4.1 The plate dimension and tolerance shall comply with GB/T 3621.
3.4.2 The bar dimension and tolerance shall comply with GB/T 2965.
3.4.3 The wire dimension and tolerance shall comply with GB/T 3623.
3.5 Properties
3.5.1 The mechanical properties of the product shall be tested on the
sample blank after thermal treatment. The sample recommended thermal
treatment system. 550??C ~ 750??C for wrought titanium, 700??C ~ 850??C for TC4, TC4ELI and TC20 alloys; insulation 0.5h ~ 3h; air cooling; wire coiling can also use vacuum annealing. The supplier can make appropriate
adjustments to the thermal treatment system.
3.5.2 The mechanical properties of the plate shall be in accordance with Table 2. The plate with a thickness not greater than 4.75 mm shall be bended according to bending core diameter and bending angle specified in Table 3. The outer surface of sample shall not be cracked.
3.6.2 The annealing status transverse microstructure of wrought titanium product shall be uniform. The average grain size shall not be above level 5 in GB/T 6394. The annealing status transverse microstructure of TC4, TC4ELI, TC20 titanium alloy products shall be ?? + ?? processing organization and be assessed according to Annex A. Other origination types shall be in
accordance with A1 ~ A9.
3.7 Surface contamination
There shall be no ?? layer and other surface contamination of TC4, TC4ELI, TC20 products after machining or grinding.
3.8 Ultrasonic testing
3.8.1 The plate and bar shall be subjected to ultrasonic testing (except for black leather products).
3.8.2 The plate of thickness greater than 6 mm shall comply with level A1 of GB/T 5193. The plate of thickness not greater than 6 mm shall be in
accordance with Annex B.
3.8.3 The bar of diameter not greater than 38.1 mm shall comply with level A1 of GB/T 5193. The bar of diameter greater than 38.1 mm shall be in
accordance with grade A of GB/T 5193.
3.9 ?? conversion temperature
When required by the purchaser and indicated in the contract, TC4, TC4ELI and TC20 bars and plates shall provide ?? conversion temperature according to furnace number.
3.10 Appearance temperature
3.10.1 The appearance of plate shall comply with GB/T 3621.
3.10.2 The appearance of bar shall comply with GB/T 2965.
3.10.3 The appearance of wire shall comply with GB/T 3623.
3.10.4 When the purchaser has particular requirements for appearance
quality, it shall be agreed by the supplier and the purchaser and indicated in the contract.
4 Test methods
4.1 Chemical composition arbitration analysis method
The chemical composition arbitration analysis method of the product shall be unqualified.
6 Mark, packaging, transport, storage
6.1 Product mark
The inspected product shall be marked with the following.
a) the imprint of the quality inspection department of the supplier;
b) manufacturer?€?s name, trademark;
c) designation, specifications;
d) supply status;
e) batch number or smelting furnace number.
6.2 Packaging, packaging mark, transport, storage
The product?€?s packaging, packaging mark, transport and storage shall comply with GB/T 8180.
6.3 Quality certificate
Each of products shall have quality certificate, indicating.
a) supplier?€?s name;
b) product?€?s name;
c) designation;
d) specifications;
e) supply status;
f) batch number or smelting furnace number;
g) product?€?s net weight, number of pieces;
h) inspection results and quali...

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