Related Experiment Video
Updated: Jan 5, 2026

Antimicrobial Characterization of Advanced Materials for Bioengineering Applications
Published on: August 4, 2018
[Discussion on the Sterilization Material in the Registration Evaluation of Sterile Medical Device]
1Center for Certification & Evaluation, SHFDA, Shanghai, 200020.
Abstract:
This article first introduces the regulation requirements for sterilization material in the registration evaluation of sterile medical devices. Secondly, the article chooses the suture passer set kit with multiple sterilization methods as an example product for technical evaluation. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluators how to make the evaluation for the medical device registration.
Related Concept Videos
Methods of Sterilization II: Chemical Methods
Using chemical sterilization rather than heat to clean out equipment is recommended. It eradicates and removes all bacteria,...
Methods of Sterilization I: Physical Methods
Steam sterilization uses non-toxic, low-cost moist heat in the form of saturated steam under pressure, which is fast, microbicidal, and sporicidal, and quickly warms and penetrates fabrics. Autoclaves, or steam sterilizers, expose each item to direct steam contact for a predetermined time at the necessary...
Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
Physical Methods for Controlling Microbial Growth: Radiation and Filtration
Key Techniques in Microbiology
Methods for Controlling Microbial Growth

