GB/T Translated English of Chinese Standard: GB/T NATIONAL STANDARD OF

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1 Translated English of Chinese Standard: GB/T GB NATIONAL STANDARD OF THE PEOPLE S REPUBLIC OF CHINA ICS H 64 GB/T Replacing GB/T Wrought titanium and titanium alloy for surgical implants 外科植入物用钛及钛合金加工材 How to BUY & immediately GET a full-copy of this standard? Search --> Add to Cart --> Checkout (3-steps); 3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your address in 0~60 minutes. 4. Support: Sales@ChineseStandard.net. Wayne, Sales manager Issued on: November 23, 2007 Implemented on: June 1, 2008 Issued by: General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration Committee. Page 1 of 22

2 Table of Contents Foreword Scope Normative references Requirements Test methods Inspection rules Mark, packaging, transport, storage Order (or contract) content Annex A (Normative) Two-phase titanium alloy metallographic classification grading chart (annealing state) Annex B (Normative) Flaw-detection method of titanium and titanium alloy sheet Lamb wave Page 2 of 22

3 Foreword When this Standard was revised, the wrought titanium processing material referred to the International Organization for Standardization ISO :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 :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 :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 :1999 (E). The mechanical performance indicator is equal to or greater than ISO 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 :1996 (E). The mechanical performance requirements are higher than ISO 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 :1994 (E). And it added low magnification testing, ultrasonic testing requirements for bars. This Standard replaces GB/T Wrought titanium and titanium alloy for surgical implants. Compared with GB/T , the main changes in this Standard are as follows: Page 3 of 22

4 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 , Designation and Composition of Titanium and Titanium Alloys GB/T , 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 α-β titanium alloys Page 5 of 22

5 vacuum consumable arc furnace smelting. The smelting must not be less than twice 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 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 Dimension and tolerance The plate dimension and tolerance shall comply with GB/T The bar dimension and tolerance shall comply with GB/T The wire dimension and tolerance shall comply with GB/T Properties 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 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. Page 7 of 22

6 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 The annealing status transverse microstructure of TC4, TC4ELI, TC20 titanium alloy products shall be α + β processing organization and be assessed according to Annex A. Other origination types shall be in accordance with A1 ~ A Surface contamination There shall be no α layer and other surface contamination of TC4, TC4ELI, TC20 products after machining or grinding. 3.8 Ultrasonic testing The plate and bar shall be subjected to ultrasonic testing (except for black leather products) The plate of thickness greater than 6 mm shall comply with level A1 of GB/T The plate of thickness not greater than 6 mm shall be in accordance with Annex B The bar of diameter not greater than 38.1 mm shall comply with level A1 of GB/T The bar of diameter greater than 38.1 mm shall be in accordance with grade A of GB/T β conversion temperature When required by the purchaser and indicated in the contract, TC4, TC4ELI and TC20 bars and plates shall provide β conversion temperature according to furnace number Appearance temperature The appearance of plate shall comply with GB/T The appearance of bar shall comply with GB/T The appearance of wire shall comply with GB/T 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 Page 10 of 22

7 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 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 quality inspection department mark; i) reference to this Standard; j) production license number; k) exit-factory date or packaging date. Page 14 of 22

8 Annex B (Normative) Flaw-detection method of titanium and titanium alloy sheet Lamb wave B.1 Scope This method specifies the requirements, procedures, inspection report and acceptance of flaw detection of titanium and titanium alloy sheet Lamb wave. This method is applicable to the Lamb wave inspection of internal defects of titanium and titanium alloy sheet within the thickness range of 0.3 mm ~ 6 mm. B.2 Normative references JB/T 10061, Commonly used specification for A-mode ultrasonic flaw detector using pulse echo technique B.3 Requirements B.3.1 Personnel The personnel engaged in the inspection shall have the expertise of the Lamb wave testing. The operators shall have departmental or equivalent academic grade I (primary) or above level qualification. The person who issues and interprets the report shall have a ministerial or equivalent level of grade II or above. B.3.2 Detector and probe B The instrument used for the Lamb wave test shall comply with the requirements of JB/T The frequency of the probe shall be in the range of 1.25 MHz ~ 5 MHz. The difference between the operating frequency of the probe and its nominal frequency shall not exceed ±5% of the nominal frequency. B The fixed angle probe housing shall be marked with the frequency, angle of incidence. Number it before it is put into use. B The leading dead zone of the probe shall be smaller. The inspection dead zone of plate end face shall not exceed 50 mm. B.3.3 Compare block Page 18 of 22

9 B.5.4 If a defect signal is found in the scan, the defect shall be detected in different directions. And use the maximum reflection signal as basis of assessment of defect. B.6 Quality acceptance B.6.1 When the discontinuity indication signal may be determined as a layered defect, it shall be rejected. B.6.2 The plate of which the discontinuity indication signal is higher than the inspection reference sensitivity shall be rejected. B.6.3 The suspicious signal whose echo amplitude is lower than the sensitivity of the inspection reference shall be further analyzed. B.7 Mark of testing piece and inspection record B.7.1 When any reflective wave height exceeds the standard, it shall mark on the surface of testing plate to indicate its position. But such mark shall not affect the results of any further ultrasonic testing. B.7.2 When inspection ends, it shall fill the flaw detection record and flaw detection report carefully. The flaw detection operator must sign (or stamp) on the record and the report. B.7.3 Ultrasonic testing records shall be kept and kept by each organization so that they can be inspected at any time. B.7.4 The inspection record shall include the following: a) plate s designation, specifications, status, quantity and furnace batch number; b) reference to this Standard; c) instrument and test block numbers, flaw detection instrument sensitivity, probe type and working frequency; d) inspection results and level; the inspection results shall at least indicate the number, position and size of the indication of discontinuities (including defects); e) date of inspection, signature of operator. B.8 Inspection report B.8.1 The inspection report shall clearly indicate whether the testing plate meets the acceptance requirements. Page 21 of 22

GB/T Translated English of Chinese Standard: GB/T NATIONAL STANDARD OF THE

GB/T Translated English of Chinese Standard: GB/T NATIONAL STANDARD OF THE Translated English of Chinese Standard: GB/T3274-2007 www.chinesestandard.net Sales@ChineseStandard.net GB NATIONAL STANDARD OF THE PEOPLE S REPUBLIC OF CHINA ICS 77.140.50 H 46 GB/T 3274-2007 Replacing