1 Scope
1.1 This standard specifies the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5% to 57.0% (mass fraction) nickel and used for the manufacture of medical devices and surgical implants.
1.2 Requirements are for mill product, measuring 6 to 130 mm diameter or thickness, in its annealed condition.
1.3 The values stated in SI units are to be regarded as standard.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 6394 Metal-methods for Estimating the Average Grain Size
YY/T 0287 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes (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 Practices for Force Verification of Testing Machines
ASTM E 8 Test Methods for Tension Testing of Metallic Materials
ASTM E 1019 Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt Alloys by Various Combustion and Fusion Techniques
ASTM E 1097 Guide for Determination of Various Elements by Direct Current Plasma Atomic Emission Spectrometry
ASTM E 1172 Practice for Describing and Specifying a Wavelength-Dispersive X-Ray Spectrometer
ASTM E 1245 Practice for Determining the Inclusion 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 Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal Conductivity/Infrared Detection Method
ASTM E 1479 Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission Spectrometers
ASTM E 1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
ASTM F 1710 Test Method for Trace Metallic Impurities in Electronic Grade Titanium by High Mass-Resolution Glow Discharge Mass Spectrometer
ASTM F 2005 Terminology for Nickel-Titanium Shape Memory Alloys
ASTM F 2082 Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
3 Terminology
3.1 The terminology describing the physical and thermal properties of these alloys shall be as defined in ASTM F 2005.
3.2 See also ASTM E 4: General Terminology.
Foreword II
1 Scope
2 Normative References
3 Terminology
4 Product Classification
5 Ordering Information
6 Manufacture
7 Chemical Composition
8 Transformation Temperature
9 Metallurgical Structure
10 Mechanical Property Requirements
11 Special Requirements
12 Certification
13 Quality Control Program
14 Keywords
Annex A (Informative) Rationale
Annex B (Informative) Biocompatibility
Annex C (Informative) Mechanical and Chemical Analysis Methods Recommended by National Standards of China
1 Scope
1.1 This standard specifies the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5% to 57.0% (mass fraction) nickel and used for the manufacture of medical devices and surgical implants.
1.2 Requirements are for mill product, measuring 6 to 130 mm diameter or thickness, in its annealed condition.
1.3 The values stated in SI units are to be regarded as standard.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 6394 Metal-methods for Estimating the Average Grain Size
YY/T 0287 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes (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 Practices for Force Verification of Testing Machines
ASTM E 8 Test Methods for Tension Testing of Metallic Materials
ASTM E 1019 Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt Alloys by Various Combustion and Fusion Techniques
ASTM E 1097 Guide for Determination of Various Elements by Direct Current Plasma Atomic Emission Spectrometry
ASTM E 1172 Practice for Describing and Specifying a Wavelength-Dispersive X-Ray Spectrometer
ASTM E 1245 Practice for Determining the Inclusion 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 Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal Conductivity/Infrared Detection Method
ASTM E 1479 Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission Spectrometers
ASTM E 1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
ASTM F 1710 Test Method for Trace Metallic Impurities in Electronic Grade Titanium by High Mass-Resolution Glow Discharge Mass Spectrometer
ASTM F 2005 Terminology for Nickel-Titanium Shape Memory Alloys
ASTM F 2082 Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
3 Terminology
3.1 The terminology describing the physical and thermal properties of these alloys shall be as defined in ASTM F 2005.
3.2 See also ASTM E 4: General Terminology.
Contents of GB 24627-2009
Foreword II
1 Scope
2 Normative References
3 Terminology
4 Product Classification
5 Ordering Information
6 Manufacture
7 Chemical Composition
8 Transformation Temperature
9 Metallurgical Structure
10 Mechanical Property Requirements
11 Special Requirements
12 Certification
13 Quality Control Program
14 Keywords
Annex A (Informative) Rationale
Annex B (Informative) Biocompatibility
Annex C (Informative) Mechanical and Chemical Analysis Methods Recommended by National Standards of China
