FDA Medical Device Sterilization

FDA

FDA Sterilization Guidance Medical Device Sterilization: To avoid disease transmission linked with the use of an item, sterilization destroys all microorganisms on its surface or in a fluid. Either a physical or chemical process that destroys or removes all microbial life in a specific area, including spores.   Sterility: the reduction of anticipated levels of…

Biological Safety Testing

What is Biocompatibility?

UKCA

What is Biocompatibility? What is Biocompatibility? – “Medical devices that come into direct or indirect contact with the body” are assessed “for the possibility for an unacceptable adverse biological reaction caused by contact of the device’s component materials with the body.”   The term Biocompatibility is described for the specific property of material being compatible…