This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, plate, coil, and hollow containing nominally 54.5 to 57.0 weight percent nickel and used for the manufacture of medical devices and surgical implants.
Requirements are for mill product measuring 5.50 to 94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill product is not intended to have the final shape, final surface finish, or final properties of the medical device, implant, or their components.
Finished NiTi tube should be considered under Specification F2633.
The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.
Any agreement between purchaser and supplier must meet the requirements of this specification.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.