Proposed Surgical Devices Standard Covers Properties for Nickel Titanium Alloy

ASTM International’s medical and surgical devices committee (F04) is developing a proposed standard for a wrought nickel-titanium alloy. The alloy covered by the proposed standard (WK84718) is commonly referred to as nitinol and is known for its super elasticity and shape memory properties.

ASTM member Weimin Yin says there is currently not a specification to address the requirements for nickel-titanium shape memory alloy wrought sheet and foil. The proposed standard will provide guidance for suppliers and users on sheet manufacturing and components designing of wrought nitinol sheet and foil.

“Nitinol can be programmed to change shape at body temperature,” says Yin, principal metallurgist at Resonetics. “This property is useful in stents and orthopedic implants, allowing them to be compressed for insertion and then expanded once inside the body. With such a unique property, nitinol has gained popularity in medical applications by improving patient outcomes and advancing minimally invasive procedures.”

The new standard will establish requirements that will support safe and effective utilization of nitinol.

This effort directly relates to the United Nations Sustainable Development Goal #3 on good health and well-being.

ASTM welcomes participation in the development of its standards.

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