Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants.
The following main technical changes have been made with respect to GB/T 13810-2007:
——TA1ELI, TA1, TA2, TA3 and TA4 are modified to TA1GELI, TA1G, TA2G, TA3G and TA4G, respectively;
——The specification range of the products is expended;
——The supply states of cold-rolled state (Y) and hot-processed state (R) are deleted;
——The requirement that recycled materials be not allowed to be used as raw materials for producing ingots and processed materials is added;
——The recommended heat treatment system for specimens is deleted;
——The yield strength requirements of wire are added;
——The requirements for microstructure of plate are modified;
——The requirements for surface pollution of TA1GELI, TA1G, TA2G, TA3G and TA4G are added;
——The requirements for ultrasonic testing are modified;
——The requirements for TC20 plate are added;
——Annex B is deleted.
This standard was proposed by China Nonferrous Metals Industry Association.
This standard is under the jurisdiction of SAC/TC 243 National Technical Committee on Nonferrous Metals of Standardization Administration of China.
The previous editions of this standard are as follows:
——GB/T 13810-1992, GB/T 13810-1997 and GB/T 13810-2007.
Wrought titanium and titanium alloy for surgical implants
1 Scope
This standard specifies the requirements, test methods, inspection rules, marking, packaging, transport, storage, quality certificate and contract (or order) contents of wrought titanium and titanium alloy for surgical implants.
This standard is applicable to titanium and titanium alloy plates, bars and wires for surgical implants.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 228.1-2010 Metallic materials - Tensile testing - Part 1: Method of test at room temperature
GB/T 232 Metallic materials - Bend test
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 4698 (all parts) Methods for chemical analysis of titanium sponge, titanium and titanium alloys
GB/T 5168 Microstructure and macrostructure examination for α-β titanium alloys
GB/T 5193-2007 Method of ultrasonic inspection for wrought titanium and titanium alloy products
GB/T 6394-2002 Determination of estimating the average grain size of metal
GB/T 8180 Wrought titanium and titanium alloy products packing, marking, transporting and storing
GB/T 23603 Test method of titanium and titanium alloy surface contamination layer
GB/T 23605 Determination of β transus temperature of titanium alloys
YS/T 1001 Method of ultrasonic inspection for sheet titanium and titanium alloy
3 Requirements
3.1 Materials
3.1.1 Ingots used to produce products shall be smelted several times. The first smelting may be carried out in a vacuum consumable electro-arc furnace or a cold-hearth furnace, and the subsequent smelting shall be carried out in a vacuum consumable electro-arc furnace, and no elements are allowed to be added in the last smelting.
3.1.2 It is not allowed to use any recycled materials of titanium and titanium alloy as raw materials for producing ingots and processed materials.
3.1.3 Consumable electrodes shall not be welded through tungsten argon arc welding.
3.2 Chemical composition
3.2.1 The chemical compositions of the products shall meet the requirements for corresponding designation specified in GB/T 3620.1, of which, the hydrogen content shall not be greater than 0.008%.
3.2.2 During re-inspection by the purchaser, the chemical composition permissible deviation of the product shall meet those specified in GB/T 3620.2.
3.3 Product classification
3.3.1 Plates
3.3.1.1 Designation, state and specification
The designation, state and specification of plates shall meet those specified in Table 1.
Table 1
Designation State Specification/mm
Thickness Width Length
TA1GELI, TA1G, TA2G, TA3G, TA4G, TC4, TC4ELI and TC20 Annealed state (M) 0.3~25.0 300~1,000 500~3,000
3.3.1.2 Overall dimensions
3.3.1.2.1 The permissible deviations of plate thickness, width and length shall meet those specified in Table 2.
3.3.1.2.2 The unevenness of the plate shall not be greater than 3mm/m.
3.3.1.2.3 The side curvature of the plate shall not be greater than 3mm/m.
3.3.1.2.4 The edge of the plate shall be cut at right angles, without cracks, turned edges, or burrs and with the skew not exceeding the permissible deviation of the length and width of the plate.
Table 2
In: mm
3.3.1.3 Tensile property
The room-temperature tensile property of plates shall meet the requirements of Table 3.
Table 3
3.3.1.4 Bending property
Plates with a thickness of not greater than 5.0 mm shall be subjected to bending test, and the bending diameter and bending angle shall meet the requirements of Table 4. After bending, there shall be no crack in the bent part.
Table 4
Table 4 (Continued)
3.3.1.5 Microstructure
The microstructures of TC4, TC4ELI and TC20 plates shall be those fully deformed and annealed in the α+β two-phase region, and the prior beta grains shall be fully broken, and continuous grain boundary α is not allowed.
3.3.1.6 Grain size
The average grain size of TA1GELI, TA1G, TA2G, TA3G and TA4G plates shall not be larger than the grain size represented by Grade 5.0 as that specified in GB/T 6394-2002.
3.3.1.7 Surface pollution
The plate shall be free of any oxygen-enriched layer, such as α layer or other surface contamination.
3.3.1.8 β transus temperature
When required by the purchaser and indicated in the contract, the measured β transus temperatures shall be provided by melting furnace number for TC4, TC4ELI and TC20 plates.
3.3.1.9 Ultrasonic testing
Plates shall be subjected to ultrasonic testing, for which, plates with a thickness of not greater than 6.0 mm shall meet the requirements of YS/T 1001, and plates with a thickness of greater than 6.0 mm shall meet the requirements of Level A1 as specified in GB/T 5193-2007.
3.3.1.10 Surface quality
3.3.1.10.1 Plates shall be supplied with pickled, water-milled, sand-blasted or machined surfaces.
3.3.1.10.2 Slight darkening and local water stain are allowed on the surface of the plate; local scratches, indentations, pits and other defects that do not exceed the permissible thickness deviation of the plate are allowed, but it shall be ensured that the plate has the minimum permissible thickness.
3.3.1.10.3 There shall be no crack, peeling, scaling, crushing, alkaline washing, metallic and non-metallic inclusions on the surface of the plate.
Foreword i 1 Scope 2 Normative references 3 Requirements 4 Test methods 5 Inspection rules Annex A (Normative) Rating diagrams for microstructure of two-phase titanium alloy bars and wires (annealed state)
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants.
The following main technical changes have been made with respect to GB/T 13810-2007:
——TA1ELI, TA1, TA2, TA3 and TA4 are modified to TA1GELI, TA1G, TA2G, TA3G and TA4G, respectively;
——The specification range of the products is expended;
——The supply states of cold-rolled state (Y) and hot-processed state (R) are deleted;
——The requirement that recycled materials be not allowed to be used as raw materials for producing ingots and processed materials is added;
——The recommended heat treatment system for specimens is deleted;
——The yield strength requirements of wire are added;
——The requirements for microstructure of plate are modified;
——The requirements for surface pollution of TA1GELI, TA1G, TA2G, TA3G and TA4G are added;
——The requirements for ultrasonic testing are modified;
——The requirements for TC20 plate are added;
——Annex B is deleted.
This standard was proposed by China Nonferrous Metals Industry Association.
This standard is under the jurisdiction of SAC/TC 243 National Technical Committee on Nonferrous Metals of Standardization Administration of China.
The previous editions of this standard are as follows:
——GB/T 13810-1992, GB/T 13810-1997 and GB/T 13810-2007.
Wrought titanium and titanium alloy for surgical implants
1 Scope
This standard specifies the requirements, test methods, inspection rules, marking, packaging, transport, storage, quality certificate and contract (or order) contents of wrought titanium and titanium alloy for surgical implants.
This standard is applicable to titanium and titanium alloy plates, bars and wires for surgical implants.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 228.1-2010 Metallic materials - Tensile testing - Part 1: Method of test at room temperature
GB/T 232 Metallic materials - Bend test
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 4698 (all parts) Methods for chemical analysis of titanium sponge, titanium and titanium alloys
GB/T 5168 Microstructure and macrostructure examination for α-β titanium alloys
GB/T 5193-2007 Method of ultrasonic inspection for wrought titanium and titanium alloy products
GB/T 6394-2002 Determination of estimating the average grain size of metal
GB/T 8180 Wrought titanium and titanium alloy products packing, marking, transporting and storing
GB/T 23603 Test method of titanium and titanium alloy surface contamination layer
GB/T 23605 Determination of β transus temperature of titanium alloys
YS/T 1001 Method of ultrasonic inspection for sheet titanium and titanium alloy
3 Requirements
3.1 Materials
3.1.1 Ingots used to produce products shall be smelted several times. The first smelting may be carried out in a vacuum consumable electro-arc furnace or a cold-hearth furnace, and the subsequent smelting shall be carried out in a vacuum consumable electro-arc furnace, and no elements are allowed to be added in the last smelting.
3.1.2 It is not allowed to use any recycled materials of titanium and titanium alloy as raw materials for producing ingots and processed materials.
3.1.3 Consumable electrodes shall not be welded through tungsten argon arc welding.
3.2 Chemical composition
3.2.1 The chemical compositions of the products shall meet the requirements for corresponding designation specified in GB/T 3620.1, of which, the hydrogen content shall not be greater than 0.008%.
3.2.2 During re-inspection by the purchaser, the chemical composition permissible deviation of the product shall meet those specified in GB/T 3620.2.
3.3 Product classification
3.3.1 Plates
3.3.1.1 Designation, state and specification
The designation, state and specification of plates shall meet those specified in Table 1.
Table 1
Designation State Specification/mm
Thickness Width Length
TA1GELI, TA1G, TA2G, TA3G, TA4G, TC4, TC4ELI and TC20 Annealed state (M) 0.3~25.0 300~1,000 500~3,000
3.3.1.2 Overall dimensions
3.3.1.2.1 The permissible deviations of plate thickness, width and length shall meet those specified in Table 2.
3.3.1.2.2 The unevenness of the plate shall not be greater than 3mm/m.
3.3.1.2.3 The side curvature of the plate shall not be greater than 3mm/m.
3.3.1.2.4 The edge of the plate shall be cut at right angles, without cracks, turned edges, or burrs and with the skew not exceeding the permissible deviation of the length and width of the plate.
Table 2
In: mm
3.3.1.3 Tensile property
The room-temperature tensile property of plates shall meet the requirements of Table 3.
Table 3
3.3.1.4 Bending property
Plates with a thickness of not greater than 5.0 mm shall be subjected to bending test, and the bending diameter and bending angle shall meet the requirements of Table 4. After bending, there shall be no crack in the bent part.
Table 4
Table 4 (Continued)
3.3.1.5 Microstructure
The microstructures of TC4, TC4ELI and TC20 plates shall be those fully deformed and annealed in the α+β two-phase region, and the prior beta grains shall be fully broken, and continuous grain boundary α is not allowed.
3.3.1.6 Grain size
The average grain size of TA1GELI, TA1G, TA2G, TA3G and TA4G plates shall not be larger than the grain size represented by Grade 5.0 as that specified in GB/T 6394-2002.
3.3.1.7 Surface pollution
The plate shall be free of any oxygen-enriched layer, such as α layer or other surface contamination.
3.3.1.8 β transus temperature
When required by the purchaser and indicated in the contract, the measured β transus temperatures shall be provided by melting furnace number for TC4, TC4ELI and TC20 plates.
3.3.1.9 Ultrasonic testing
Plates shall be subjected to ultrasonic testing, for which, plates with a thickness of not greater than 6.0 mm shall meet the requirements of YS/T 1001, and plates with a thickness of greater than 6.0 mm shall meet the requirements of Level A1 as specified in GB/T 5193-2007.
3.3.1.10 Surface quality
3.3.1.10.1 Plates shall be supplied with pickled, water-milled, sand-blasted or machined surfaces.
3.3.1.10.2 Slight darkening and local water stain are allowed on the surface of the plate; local scratches, indentations, pits and other defects that do not exceed the permissible thickness deviation of the plate are allowed, but it shall be ensured that the plate has the minimum permissible thickness.
3.3.1.10.3 There shall be no crack, peeling, scaling, crushing, alkaline washing, metallic and non-metallic inclusions on the surface of the plate.
Contents of GB/T 13810-2017
Foreword i
1 Scope
2 Normative references
3 Requirements
4 Test methods
5 Inspection rules
Annex A (Normative) Rating diagrams for microstructure of two-phase titanium alloy bars and wires (annealed state)
