深圳市药品检验研究院 a. 体外诊断试剂检测部；b. 无源医疗器械检测部；c. 医疗器械检测中心，广东 深圳 518057
Biological Safety Evaluation of Nitinol Treated by Atmospheric Thermal Oxidation
LIN Zhongshia, HUANG Hongronga, ZANG Deyueb, XU Weiqub, LIN Baiyoub, YUAN Lixinb, XU Liangc, LIU Yaoa
a. Department of In-vitro Diagnostic Reagent Testing; b. Department of Passive Medical Device Testing; c. Medical Device Testing
Center, Shenzhen Institute for Drug Control, Shenzhen Guangdong 518057, China
Abstract：Nitinol materials with routine modeling procedure was subjected to comprehensive biosecurity evaluation to provide safe
basis for the production and application of medical products, especially in the area of implant interventional devices. To simulate
the routine application of nitinol in the production of medical devices, nitinol material was molded into nitinol wire. Then, based on
a series of GB/T 16886 medical equipment biology evaluation standards, nitinol wire was subjected to a series of tests, including
pyrogen test, cytotoxicity test, intradermal reaction test, late-onset hypersensitivity test, hemolysis test, thrombosis test, sub-chronic
systemic toxicity test, muscular implantation test, acute systemic toxicity test, and genotoxicity test. The result showed that the
biological safety of nitinol materials after thermal oxidation treatment under common atmosphere conforms to the requirements of
current standards.
