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...
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....
Using chemical characterization 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...
In March of 2017, the new ISO 18562 standard series was released. This standard covers the general principles regarding biocompatibility assessment of medical device materials which comprise the gas pathway....
There are many considerations that need to be taken into account by medical device manufacturers when designing reprocessing validations, and it only takes one oversight to cause a failure mode....
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