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.
medical devices; metals (for surgical implant); nickel-titanium alloys; niti; nitinol; shape memory alloy; surgical implants; wire
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.
The title and scope are in draft form and are under development within this