GB 24627-2009
Standard specification for wrought Nickel-Titanium shape memory alloys for medical devices and surgical implants (English Version)

Standard No.

GB 24627-2009

Language

Chinese, Available in English version

Release Date

2009

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Status

Be replaced 2025-01

Replace By

GB/T 24627-2023

Latest

GB/T 24627-2023

Scope

This standard specifies the chemical, physical, mechanical and metallurgical requirements for nickel-titanium memory alloy rods, plates and tubes with a nominal composition (mass fraction) of 54.55%-57.0% nickel for the manufacture of medical devices and surgical implants. For rolled products with a diameter or thickness of 6mm-130mm, this standard refers to the requirements under the annealed condition. The data in this standard use the International System of Units (SI).

GB 24627-2009 Referenced Document

• ASTM E1019 Standard Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel and in Iron, Nickel, and Cobalt Alloys*， 2024-04-19 Update
• ASTM E1097 Standard Guide for Direct Current Plasma Emission Spectrometry Analysis
• ASTM E1172 Standard Practice for Describing and Specifying a Wavelength-Dispersive X-Ray Spectrometer
• ASTM E1245 Standard Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis
• ASTM E1409 Standard Test Method for Determination of Oxygen in Titanium and Titanium Alloys by the Inert Gas Fusion Technique
• ASTM E1447 Standard Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal Conductivity Method
• ASTM E1479 Standard Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission Spectrometers
• ASTM E1941 Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys
• ASTM E4 Standard Practices for Force Verification of Testing Machines
• ASTM E8 Standard Test Methods for Tension Testing of Metallic Materials
• ASTM F1710 Standard Test Method for Trace Metallic Impurities in Electronic Grade Titanium by High Mass-Resolution Glow Discharge Mass Spectrometer
• ASTM F2005 Standard Terminology for Nickel-Titanium Shape Memory Alloys*， 2021-03-01 Update
• ASTM F2082 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery*， 2024-04-19 Update
• GB/T 6394 Determination of estimating the average grain size of metal*， 2017-02-28 Update
• YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
• YY/T 0641 Standard Test Method for Transformation Temperature Of nickel.Titanium Alloys by Thermal analysis

GB 24627-2009 history

• 2023 GB/T 24627-2023 Nickel-titanium shape memory alloy processing materials for surgical implants
• 2009 GB 24627-2009 Standard specification for wrought Nickel-Titanium shape memory alloys for medical devices and surgical implants

GB 24627-2009 Standard specification for wrought Nickel-Titanium shape memory alloys for medical devices and surgical implants was changed to GB/T 24627-2023 Nickel-titanium shape memory alloy processing materials for surgical implants.