GB ××××× —××××  
 
ICS 11.040.30  
C_36  
 
 
National Standard for the People’s Republic of China  
GB ×××× —××××  
 
Standard Specification fo r Wrought Nickel -Titanium Shape -Memory 
Alloys for Medical Devices and Surgical Implants  
(Draft for Approval)  
Released on ××/××/××××                 Implemented on ×× /××/××××  
Issued by  
 
General Adminis tration of Quality Supervision,  
Inspection and Quarantine of the People’s Republic of China  
Standardi sation Administration of the People’s Republic of ChinaTABLE OF CONTENTS  
 
Introduction ................................ ................................ ................................ ................................ ......3 
1. Scope ................................ ................................ ................................ ................................ ....... 4 
2. Normative Quoted Documents ................................ ................................ ................................ 4 
3. Terms ................................ ................................ ................................ ................................ ....... 5 
4. Product Categories ................................ ................................ ................................ .................. 5 
5. Order Information ................................ ................................ ................................ .................... 5 
6. Manufacture ................................ ................................ ................................ ............................. 6 
7. Chemical Compositions ................................ ................................ ................................ .......... 6 
8. Phase -transition Temperature ................................ ................................ ................................ ..7 
9. Metallurg ical Structure ................................ ................................ ................................ ............ 8 
10.  Requirement for Mechanical Property ................................ ................................ ..................... 8 
11.   Specia l Requirements ................................ ................................ ................................ ............. 9 
12.   Certificates ................................ ................................ ................................ ............................. 9 
13.   Quality Control Process ................................ ................................ ................................ ......... 9 
14.   Key Words ................................ ................................ ................................ ............................ 10 
Annex A (Informative Annex) Elaboration of Principles ................................ ............................... 10 
Annex B (Informative Annex) Biocompatibility ................................ ................................ ............ 12 
Annex C (Informative Annex) Mechanical and Chemical Analy sing Methods Recommended by 
the National Standard ................................ ................................ ................................ ..................... 13 
 
  
Introduction  
All the technical contents of the s tandard are binding . 
The standard is applicable to  the ASTM  F2063 -05 Wrought Nickel -Titanium 
Shape -Memory Alloys for Medical Devices and Surgical Implants  (English Version). 
The major differences between the standard and the ASTM F2063 -05 are as fo llows:  
a) Replace the ASTM standard that has been transformed into national standard or 
industrial standard in the normative quoted documents with national standard or 
industrial standard;  
b) replace the American Society of Quality ASQstandard in the normative q uoted 
documents with industrial standard;  
c) add the mechanical and chemical analy sing methods recommended by the national 
standard as Annex C (Informative Annex). Annex A, Annex B and Annex C of the 
standard are informative annex es. The standard is put f orward by the State Food and 
Drug Administration. The jurisdictional unit of the standard is the National Technical 
Committee 110 on Surgical Implants an d Orthotic Devices of Standardis ation 
Administration of China (SAC/TC 110). The drafting units of the s tandard include 
Grikin Advanced Materials Co., Ltd. and Tianjin Medical Instrumentation Inspection 
Centre of SDA.  
The major drafters of th e standard are Feng Jingsu, Miu Weidong, Wang Jiangbo, 
Feng Zhaowei, Yanghua; Fan Bo, Sun Huili and Song Duo.  
 
 GB ×××× —××××  
 
 
Wro ught Nickel -Titan ium Shape -Memory Alloys for Medical Devices and 
Surgical Implants  
1. Scope  
1.1. The standard prescribes the chemical, physical, mechanical and metallurg ical 
requirements for the wrought nickel -titanium memory alloy bar, sheet and tube 
materials us ed to manufacture medical devices and surgical implants , and the 
nominal composition (mass fraction) is 54.5% 57.0% nickel.  
1.2. For rolling products with a diameter or thickness of 6mm -130mm, the standard 
refers to the requirements under annealing condition s. 
1.3. The data in the standard uses SI.  
 
2. Normative Quoted Documents  
Clauses in the following documents have been quoted by this standard and become 
clauses of this standard. For documents marked with date, their amendments or revise d 
versions are inapplicable.  It is encouraged that parties that have reached an agreement 
can discuss whether the latest edition of these documents can be adopted. For 
documents without date, their latest editions are applicable to this standard.  
GB/T 6394 Metal  methods for estimati ng the average grain size  
YY/T 0287 Medical device  quality management system  requirements for 
regulatory YY/T 0287 —2003,  ISO 13485:2003,  IDT 
YY/T 0641 Standard test method for transformation temperature of 
nickel —titanium alloys by thermal analysis  
ASTM E 4 Standard Practice for Testing Machine Load Test  
ASTM E 8 Testing Method of Tensile Test for Metallic Materials  
ASTM E 1019 Standard Test Methods for Determination of Carbon , Sulphur, 
Nitrogen and Oxygen in Steel and in Iron, Nickel and Cobalt Alloys  
ASTM E 1097 Instruction s for Direct Current Plasma Emission Spectrum Analysis  
ASTM E 1172 Standard Procedure for Description and Prescription of Wavelength 
Dispersive X -ray Spectrometer   
ASTM E 1245 Standard Operatin g Procedure of Determining the Inclusi on or 
Second -Phase Constituent Content of Metals by Automatic Image Analysis  
ASTM E 1409 Test Method for Determination of Oxygen and Nitrogen in Titanium 
and Titanium Alloys by the Inert Gas Fusion Technique  
ASTM E 1447 Test Method for Determination of Hy drogen in Titanium and 
Titanium Alloys by the Inert Gas Fusion Thermal Conductivity/Infrared Detection 
Method  GB ×××× —××××  
ASTM E 1479 Standard Procedure for Description and Prescription of Inductance 
Coupling Plasma Emission Spectrometer  
ASTM E 1941 Test Method for D etermination of Carbon in Refractory and Active 
Metal and its Alloys  
ASTM F 1710 Test Method for Anal ysing Trace Metal Elements in Electronic 
Grade Titanium by High Resolution Glow Discharge Mass Spectrometry  
ASTM F 2005 Terms for Nickel -Titanium Shape -Memory Alloys  
ASTM F 2082 Test Method for Determination  of the Phase -transition Tempe rature 
of Nickel -Titanium Shape -Memory Alloys by Bend and Free Restore Tests  
3. Terms  
3.1. For the terms describing the physical and thermal performance, see ASTM F 
2005.  
3.2. See also  ASTM E 4: General Terms.  
 
4. Product Categories  
4.1. Bar Material: Round bar or bar material with ot her sections (specially 
customis ed dimension or shape)  
4.2. Sheet material: Any products with width no less than five times thickness.  
4.3. Tube material: Hollow column -shaped product.  
 
5. Order Information  
The following information shall be included when enquiring about price or ordering 
goods according to the standard:  
a) Quantities: Weight, length or number of items;  
b) Alloy E lement: Indicated by phase -transitional temp erature (see Chapter 8);  
c) Shape: Bar, sheet or tube (see Chapter 4);  
d) State: (see 6.3 and 10.1);  
e) Mechanical Property: Applicable in special conditions (see Chapter 10);  
f) Surface Condition: (see 6.4);  
g) Applicable Dimension: includes diameter, thickness, width and length (accurate 
length, discretional length or integral times of given length) or identification 
number;  
h) Special Inspection: Such as the chemical analysis of final rolling products;  
i) Special Requirements (see Chapter 11).  GB ×××× —××××  
 
6. Manuf acture  
6.1. The material shall be produced by casting  ingot s containing nickel and titanium 
without any other additional elements.  
6.2. The material shall be fused in a vacuum or ine rt gas to control the metallurgical  
purity and chemical compositions of alloys.  
6.3. According  to the requirements of the order, products made by bar, sheet and 
tube materials shall be delivered under the states of hot or cold working, 
annealing or other thermal treatment.   
6.4. The surface states can be processed by oxidation layer, scale remova l, acid 
washing, sand blasting, mechanical processing, grinding, mechanical polishing 
or electrolytic polishing.  
 
7. Chemical Compositions  
7.1. The chemical compositions of the alloy shall conform with the requirements in 
Table 1. Except the hydrogen element, the  elements in Table 1 can anal yse the 
sample from the casting ingot. The h ydrogen element shall anal yse the sample 
from the final rolling products (see Chapter 4), or sample and anal yse in a way 
in which the supplier and user agree. For chemical composition s beyond the 
scope and range given by Table 1,  the supplier shall not deliver.  
See Table 1 for the requirements for the major constituents of alloys and impurity 
element content. The standard has no requirements for elements that are not listed in 
Table 1.  These elements need  not be anal ysed. 
Table 1 Chemical Composition  
Element  Mass Fraction, %  
Nickel (Ni)  54.557.0  
Carbon (C) 0.050  
Cobalt (Co)  0.050  
Copper  (Cu) 0.010  
Chromium (Cr)  0.010  
Hydrogen (H)  0.005  
Iron (Fe)  0.050  
Niobium (Nb)  0.025  
Nitrogen+Oxygen (N+O)  0.050  
Titanium (Ti)  Surplus Amount  
7.2. Anal ysing Method ----The major constitue nts shall be anal ysed according 
to the Direct Current Plasma Spectrum Method prescribed in ASTM E 
1097, the Atom Absorption Inductance Coupling Plasma Spectrum 
Method in ASTM E 1479,  the X-ray Spectrum Method in ASTM E 1172,  
Glow Discharge Mass Spectrometr y in ASTM F 1710 or equivalent 
methods; carbon content shall be determined according to the methods GB ×××× —××××  
prescribed in ASTM E 1019 or ASTM E 1941; hydrogen content shall be 
determined according to the Inert Gas Fusion method or  the vacuum 
extraction method pres cribed in ASTM E 1447; nitrogen and oxygen 
content shall be determined according to the Inert Gas Fusion method 
prescribed in ASTM E 1409.  
Note: Major constituents can also be anal ysed according to the methods in YS/T 
252.1.  
7.3. The titanium content of alloy s shall be determined by tail -difference method 
and is unnecessary to anal yse. 
7.4. See Table 2 for the maximum anal ysing permissible difference of the products. 
The anal ysing permissible difference of the products shall not loosen the 
requirements for the const ituent analysis, but cover the differences on the 
chemical constituents measurements. For materials beyond the range of 
constituent content given by Table 1, the supplier shall not deliver.  
 
Table 2 Anal ysing Permissible Difference of the Products1) 
 
Elem ent Permissible Difference,% m/m 2 
Carbon (C)  
Cobalt (Co)  
Copper  (Cu)  
Chromium(Cr)  
Hydrogen (H)  
Iron (Fe)  
Nickel (Ni)  
Niobium (Nb)  
Nitrogen (N)  
Oxygen (O)  0.002  
0.001  
0.001  
0.001  
0.0005  
0.01 
±0.2 
0.004  
0.004  
0.004  
1) The determination of the anal ysing permissible difference of th e 
products is based on the proven anal ysing ability of the constituent.  
2) For elements to which the minimum permissible difference is not 
applicable, only the maximum percentage will be given.  
 
8. Phase -transition Temperature  
8.1. Because the measuring accuracy of the nickel and titanium content of the 
nickel -titanium shape -memory alloys can not achieve the requirements to 
assure shape  memory or superelasticity, therma l analysis or equivalent 
thermo mechanical testing methods shall be applied to test the phase -transition 
temperature of alloys and assure the constituents of all oys in terms of the 
temperature .  
8.2. Constituents of alloys shall be prescribed according to the phase -transition GB ×××× —××××  
 
temperature parameter required by the order. Phase -transition temperature 
paramete r shall be one of the follow ing: M f, M p, M s, A s, A p, A f; see ASTM F 
2005 for the definition; the parameter shall be tested by YY/T 0641 , ASTM F 
2082 or other applicable thermo mechanical testing methods.  
8.3. When measuring phase -transition temperature by the thermal anal ysing 
method prescribed in YY/T0641, the measuring value of A s shall be within 
±10 of the processing temperature of the purchased product, or within a 
range agreed by supplier and user.   
8.4. Generally, the phase -transition temperature parameter sha ll be determined 
under the annealing condition of the processing product (as defined in ASTM  F 
2005). Determination of the phase -transition temperature of alloys under other 
conditions shall be regarded as a special requirement.  
 
9. Metallurg ical Structure  
9.1. Microstructure  
For inspection using the testing method in GB/T 6394, the average grain size (G) of 
the product shall be no thicker than Level 4.  
9.2. Microcleanliness  
For all rolling products, the maximum permissible dimension of the porosity and 
non-metal incl usions (such as Ti 4Ni2Ox and TiC) grain is 39.0m. When visually 
observ ing scarring up to 400× 500×, the porosity and non -metal inclusions shall be 
no more than 2.8% (area percentage). Evaluation of the porosity and non -metal 
inclusions shall be carried  out on a 6.3mm 94.0mm section on the direction of 
diameter, thickness, width, height and wall thickness of rolling products. Inspection 
shall apply the method of ASTM E 1245 or equivalent method and use an axial 
sample parallel to processing direction. Suppl ier and buyer shall agree on number of 
samples, sampling position, sample preparation, the amount  of visual observation 
and inspecting technology.  
10. Requirement for Mechanical Property  
10.1. For the sample chosen from the final products, after annealing (heat the  
material with the temperature no lower than 800  and for no less than 15 
minutes) and quick cooling treatments such as water quenching, air quenching 
or air cooling, the mechanical property shall conform to the requirements in 
Table 3.  
 
Table 3 Mechanical Property under Annealing Condition  GB ×××× —××××  
Diameter or  the Interval 
between the  Two Parallel 
Surfaces,  
mm Tensile 
Strength, R m. 
MP a Extensibility, A, Measuring 
Length 50mm or 4D%  
50 551  15  
50 551  10  
Note: Testing ambient temperature is 20.0 24.0. 4D refers to four  times 
the diameter.  
10.2 To ensur e the product  has higher terminal tensile strength and lower 
extensibility, or other physical and mechanical properties, the materials can be 
ordere d under the cold -working or hot -working conditions.  
10.3 For products with a diameter of thickness more than 50mm , sampling may 
come after rolling them to sheet or strip materials. For products with a diameter of 
thickness no more than 50mm, samples shall be selected from the products.   
10.4 Tensile strength inspection shall be carried out on the axial direction 
correspo nding to the final processing direction of the sample. Transverse tensile 
strength of wide sheet products shall be inspected using  the method agreed by the 
user and supplier.  
10.5 The t ensile test shall be carried out according to that prescribed by ASTM E  8 
and use a sample with the standard length applicable to tested dimension. Tensile 
strength shall conform to the requirements in Table 3.  
10.6 Other special mechanical property tests shall be prescribed in the order.  
 
11. Special Requirements  
11.1. Dimension al tolerance and elliptical tolerance shall be prescribed in the 
order.  
11.2. Requirements for special phase -transition temperature raised according to 
the product shape, sampling position or thermal treatment shall be prescribed 
in the order.  
11.3. Surface roughness shall be pr escribed in the order.  
 
12. Certificates  
The s upplier shall provide the certificate to show the materials are manufactured 
and inspected according to the standard in delivery. The certificate shall include the 
summary of the chemical constituents, phase -transi tion temperature, metallurgical  
structure, instruction s for metallurg ical structure analysis and the testing result s of the 
mechanical property agreed by user and supplier  (see Chapter 7, 8, 9 and 10 ) 
13. Quality Control Process  
Supplier shall keep certain quality control process es, for example, conforming to GB ×××× —××××  
 
the requirements of YY/T 0287.  
14. Key Words  
Heart instruments; metal; NiTi, TiNi; nickel -titanium memory alloys; 
nickel -titanium alloys; titanium -nickel alloys; orthodontic medical instruments; blood 
vessel instrument s; shape -memory alloys; bracket;  superelastic alloys; surgical 
implants.   
 
 
 
Annex A  (Informative Annex)  Elaboration of the Principles  
A. 1 The standard prescribes the chemical, physical, t hermo mechanical and 
metallurgical  properties for the wrou ght n ickel -titanium memory alloy processing 
materials that  are used to manufacture medical devices and surgical implants and the 
nominal composition (mass fraction) is 54.5% 57.0% nickel.  
A. 2 The u ser shall choose the phase -transition temperature and mechanical property of 
shape -memory alloys according to the design and usage requirements of medical 
instruments.   
A.3 The t herm omechanical processing procedure (especially col d-working and thermal 
treatment s) may influence the phase -transition temperature and other physical and 
mechanical propert ies of nickel -titanium shape -memory alloys. The a nnealing 
condition prescribed in 8.4 and 10.1 is only applicable to testing samples, the final 
products are usually delivered under cold -working or cold -working plus thermal 
treatment conditions.  
A. 4 Thermo mechanical processing procedure and chemical treatment may influence 
the chemical anal ysing results of the casting ingot. For example,  acid washing will 
increase the hydrogen content. Therefore, hydrogen content is prescribed to be sampled 
from final rolling products (see 7.2).  
A. 5 The n ickel -titanium alloy involved in the standard is usually refer red to as 
nickel -titanium memory alloy. This is not a single alloy, but a family of alloys marked 
by phase -transition temperature, which is measured under the controlling condition GB ×××× —××××  
after the prescribed therm omechanical processing procedure.  
A. 6 Phase -transition temperature consistency refers  to the As range to a constituent 
alloy measured by a lab according to the testing method in YY/T 0641.  
A. 7 The e lements carbon, cobalt, copper , hydrogen, iron, niobium and oxygen are 
residual elements in alloys (see Table 1). The residual elements are c ontrolled within 
the prescribed range to ensure the good physical and  mechanical properties of 
shape -memory alloy.  The determination of the anal ysing permissible difference of the 
products is based on the proven anal ysing ability of the constituent.   
 GB ×××× —××××  
 
 
Annex B  (Informative Annex)  Biocompatibility  
The materials and constituents involved in the standard have been successfully 
applied as surgical implant s and reflect their good biological reaction characteristics. 
References are as follows:  
[1] Castleman, L.S., et al., “Biocompatibility of Nitinol Alloy as an Implant 
Material,”  J. Biomedical Materials Research , Vol 10,  1976, pp. 695 -731.  
[2] Ryhanen, J., et al., “Biocompat ibility of Nickel Titanium Shape -Memory Metal 
and its Corrosion Behavior in Human Cel l Cultures,” J. Biomedical Materials Research , 
Vol. 35, 1997, pp. 451 -457.  
[3] Trigwell,  S., and Selvaduray,  G., “Effects of Surface Finish on the Corrosion of 
NiTi Alloy for Biomedical Applications,” SMST -97 Proceedings of the Second 
International Confer ence on Shape Memory and Superelastic Technologies , Pelton, A .,  
et al., (eds.), SMST, Santa Clara, CA, 1997, pp. 383 -388.  
[4] Wever,  D.J., et al., “Cytotoxic,  Allergic and Genotoxic Activity of a 
Nickel -Titanium Alloy,” Biomate rials, Vol.18,  No.16,  1997,  pp. 1115 -1120.  
[5] Trepanier, C. , et al., “Effect of the Modification of the Oxide Layer on NiTi 
Stent Corrosion Resistance,” J. Biomedical Materials Research , Vol. 43, 1998,  pp. 
433-440.  
[6] Ryhanen,  J., “ Biocompatibility of Nitinol,”  Minimally Invasi ve Therapy and 
Allied Technology,  Vol. 9, No. 2, 2000,  pp. 99-105.  
[7] Venugopalan,  R., and Trepanier,  C., “Assessing the Corrosion Behavior of 
Nitinol for Minimally Invasive Device Design,” Minimally Invasive Therapy and 
Allied Technology,  Vol. 9, No. 2, 2000,  pp. 67-73.  
[8] Thierry,  B., et al., “Nitinol versus Stainless Steel Stents: Acute 
Thrombogenicity Study in an Ex -Vivo Porcine Model,” Biomaterials , Vol.  23, 2002,  
pp. 2997 -3005.  
[9] Zhu,  L., et al., “Oxidation of Nitinol and its Effect on Corrosio n Resistance,” S. 
Shrivastava , Proceedings from the Materials  & Processes for Medical Devices 
Conference , 8-10 Sept. 2003, Anaheim, CA,  ASM International, 2004,  pp. 156-161.  
No recently known s urgical implant is proven  to be completely nontoxic to the 
human body , but with the materials involved in the standard it has been shown in 
long-term clinical application that the anticipated  level of  biological reaction 
characteristics is acceptable if used appropriately.  
  GB ×××× —××××  
 
Annex C  (Informative Annex)  Mechanical and Chemical Anal ysing Methods 
Recommended by the National Standard  
GB/T 228 Metallic Materials Tensile Testing at Ambient Temperature  
GB/T 4698.7  Sponge titanium, titanium and titanium alloys  - determination of ni trogen 
content by d istillation -Nessler rea gent spectrophotometric method  
GB/T 4698.14 Sponge titanium, titanium and titanium alloys  - determination of carbon 
content, combustion -coulometric method  
GB/T 4698.15 Sponge titanium , titanium and titanium alloys  - determination of 
hydrogen content , vacuu m heating gas chromatographic method   
GB/T 4698.16 Sponge titanium , titanium and titanium alloys  - determination of oxygen 
content , inert gas fusion coulometric method