New Specification for Wrought Nickel-Titanium Shape Memory Alloy Wire for Medical Devices and Surgical Implants
1. Scope
This specification covers the requirements for wrought nickel-titanium shape memory alloy wire, nominally 54.5 to 57.0 mass/mass (weight) % nickel, used for the manufacture of medical devices and surgical implants. Material shall conform to the applicable requirements of Specification F2063. This specification addresses those product variables that differentiate drawn medical grade wire from the raw material and mill product forms covered in Specification F2063.
No standard specification defining requirements for nickel-titanium shape memory alloy wire for use in medical devices and surgical implants exists. This standard specification will be used by medical device companies, metal wire producers and government agencies to ensure consistent product and assist with quality control.
