This specification covers the requirements for wrought nickel-titanium shape memory alloy flat rolled products including plate, sheet and foil, 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 flat rolled plate, sheet and foil 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; flat rolled product; plate; sheet; foil.
There is no standard specification to address the requirements specifically for nickel-titanium shape memory alloy flat rolled plate, sheet and foil. This proposed new standard specification will be used by medical device companies, metal 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