Technical considerations for non-clinical assessment of medical devices containing nitinol: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, July 9, 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Alloys Equipment Design Equipment Safety Nickel Titanium United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- Nitinol, a near equiatomic alloy of nickel and titanium, is a commonly used material in the medical device industry. Device manufacturers have used nitinol’s unique properties (e.g., pseudoelasticity and shape memory behavior) to design innovative medical devices that would not be possible with conventional materials. Nitinol has been extensively used in cardiovascular devices such as stents, heart valves, guidewires, and vena cava filters. The use of nitinol in other device areas is growing, particularly for products intended for use in minimally invasive procedures. The thermomechanical behavior and processing sensitivity of nitinol raise special considerations when compared to conventional metals such as stainless steel, titanium or cobaltchrome alloys. The Agency has developed this guidance to provide FDA’s current thinking on technical considerations specific to devices using nitinol due to the unique properties of nitinol. The recommendations in this document should be evaluated in conjunction with the intended use and technological characteristics of your device and any relevant device-specific guidances. The purpose of this guidance is to outline technical considerations associated with medical devices that have at least one patient-contacting component comprised of nitinol.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (16 pages)).
- NLM Unique ID:
- 9918231190406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918231190406676