GB/T 13810-2017 English PDF (GBT13810-2017)

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GB/T 13810-2017: Wrought titanium and titanium alloy for surgical implants
GB/T 13810-2017
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 77.150.50
H 64
Replacing GB/T 13810-2007
Wrought titanium and titanium
alloy for surgical implants
ISSUED ON. OCTOBER 14, 2017
IMPLEMENTED ON. MAY 01, 2018
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Requirements ... 6 
4 Test methods ... 14 
5 Inspection rules ... 15 
6 Marks, packaging, transport and quality certificate ... 18 
7 Contract (or order) content ... 18 
Annex A (normative) Two-phase titanium alloy bar and wire microstructure
rating chart (annealed state) ... 20 
Wrought titanium and titanium
alloy for surgical implants
1 Scope
This Standard specifies the requirements, test methods, inspection rules as well
as marks, packaging, transport, storage, quality certificate and contract (or
order) content of wrought titanium and titanium alloy for surgical implants.
This Standard is applicable to sheet, bar and wire of wrought titanium and
titanium alloy 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, Metal - Methods for estimating the average grain size
GB/T 8180, Wrought titanium and titanium alloy products packing marking
transporting and storing
3.3.1.5 Microstructure
The microstructures of TC4, TC4ELI and TC20 sheets shall be sufficiently
deformed and annealed in the α+β two-phase region. The original β grain
should be fully broken. The continuous grain boundary α is not permitted.
3.3.1.6 Grain size
The average grain size of TA1GELI, TA1G, TA2G, TA3G and TA4G sheets shall
not be coarser than level 5.0 in GB/T 6394-2002.
3.3.1.7 Surface contamination
The sheet shall be free of any oxygen-rich layer, such as α layer or other surface
contamination.
3.3.1.8 β transition temperature
As required by the purchaser and indicated in the contract, TC4, TC4ELI and
TC20 sheets shall be provided with the actual measured values of β transition
temperature according to furnace number.
3.3.1.9 Ultrasonic testing
The sheet shall be subjected to ultrasonic testing. Sheet with a thickness not
exceeding 6.0 mm shall comply with the requirements of YS/T 1001. Sheet with
a thickness greater than 6.0 mm shall comply with the requirements of Level A1
of GB/T 5193-2007.
3.3.1.10 Surface quality
3.3.1.10.1 Sheets shall be supplied in pickled, water milled, sandblasted or
machined surfaces.
3.3.1.10.2 A slight darkening and localized water trace is allowed on the surface
of the sheet. Local flaws such as scratches, indentations, pits, etc. that do not
exceed the allowable deviation of their thickness are allowed. However, the
minimum thickness allowed for the sheet shall be guaranteed.
3.3.1.10.3 Cracks, peeling, oxide scale, crimping, over-alkaline washing, metal
and non-metallic inclusions are not allowed on the surface of the sheet.
3.3.1.10.4 Sheet allows for the removal of local defects along the rolling
direction. However, the minimum thickness allowed for the sheet shall be
ensured after removal.
3.3.1.10.5 Sheet shall not have delamination.
3.3.2 Bar
3.3.3.4 Macrostructure
Layers, cracks, pores, shrinkage, metal or non-metallic inclusions and other
visible metallurgical defects are not permitted on macrostructure of wires with
a diameter larger than 3 mm.
3.3.3.5 Microstructure
The microstructure of TC4, TC4ELI and TC20 wire shall be the structure which
is fully deformed and annealed in the α+β two-phase region. Its structure type
shall conform to a) ~ i) of Figure A.1.
3.3.3.6 Grain size
The average grain size of TA1GELI, TA1G, TA2G, TA3G and TA4G wires shall
not be coarser than level 5.0 in GB/T 6394-2002.
3.3.3.7 Surface contamination
The wire shall be free of any oxygen-rich layer, such as alpha layer or other
surface contamination.
3.3.3.8 Surface quality
3.3.3.8.1 Wire shall be supplied in pickled or polished surface.
3.3.3.8.2 The surface of the wire shall be clean, free from oxidation, and shall
not have cracks, peeling, tingling, streaks and inclusions.
3.3.3.8.3 The surface of the wire is allowed to have slight scratches, scratches,
spots and pits that do not exceed the allowable deviation of the diameter.
4 Test methods
4.1 Conduct the chemical composition analysis according to GB/T 4698.
4.2 Measure dimensions with tools of corresponding appropriate accuracy. The
thickness of the sheet shall be measured within the range of 10mm~100mm
from the edge of the sheet.
4.3 Tensile properties at room temperature are carried out according to GB/T
228.1-2010. The specimen shall comply with the requirements of Table 11.
Bending performance 1 transverse specimen at random from each batch 3.3.1.4 4.4
Macrostructure 1 transverse specimen at random from each batch
3.3.2.4
3.3.3.4 4.5
Microstructure 1 transverse specimen at random from each batch
3.3.1.5
3.3.2.5
3.3.3.5
4.6
Grain size 1 transverse specimen at random from each batch
3.3.1.6
3.3.2.6
3.3.3.6
4.7
Surface
contamination
1 specimen at random from
each batch
3.3.1.7
3.3.2.7
3.3.3.7
4.8
β transition
temperature
1 specimen at random from
each batch
3.3.1.8
3.3.2.8 4.9
Ultrasonic testing One by one (piece) 3.3.1.9 3.3.2.9 4.10
Surface quality One by one (piece, roll)
3.3.1.10
3.3.2.10
3.3.3.8
4.11
5.4 Determination of inspection results
5.4.1 When the chemical composition test result is unqualified, it shall allow to
perform a re-inspection for the unqualified element. Should the re-inspection
still fail, this batch of products shall be unqualified.
5.4.2 In the tensile properties, bending properties, microstructure, grain size
and surface contamination tests, if the test results of one specimen fail, it shall
take the specimens double the number from this batch of products for the re-
inspection of unqualified item. Should the re-inspection still fail, this batch of
products shall be unqualified. However, the supplier is allowed to inspect the
unqualified items one by one (piece, roll). Re-batch the qualified products.
5.4.3 The determination of macrostructure shall comply with the provisions of
5.4.3.1 and 5.4.3.2.
5.4.3.1 If segregation, metal or non-metallic inclusions and other visually visible
metallurgical defects are found on macrostructure, this batch shall be rejected.
The supplier is allowed to inspect the unq...