The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate options are now available to reduce animal testing by using literature research and chemical characterization tests when appropriate. Additionally, there has been considerable progress in...
The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate options are now available to reduce animal testing by using literature research and chemical characterization tests when appropriate. Additionally, there has been considerable progress in...
Using extractables and leachables chemistry testing to support biocompatibility assessments and cleaning validations for medical devices is now widely accepted, but it remains a moving target as the approaches develop. A variety of chemical characterization strategies are now available with differing degrees of scientific rigor and diverse regulatory body acceptance. New regulatory draft documents will...
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