Regulatory

Proposed Surgical Devices Standard Covers Nickel Titanium Alloy Properties

Also known as nitinol, nickel-titanium has super elastic and shape memory properties.

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By: Michael Barbella

Managing Editor

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.

There currently is no specification to address requirements for nickel-titanium shape memory alloy wrought sheet and foil, according to ASTM member Weimin Yin. 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,” said 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.

More than 12,000 ASTM standards operate globally. Defined and set by ASTM International, these standards improve daily life. Committed to serving global societal needs, ASTM International positively impacts public health and safety, consumer confidence, and overall quality of life. The organization integrates consensus standards developed with its international membership of volunteer technical experts. ASTM International is based in West Conshohocken, Pa.

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