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...
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 chemical characterization strategies are now available with differing degrees of scientific rigor and diverse regulatory body acceptance. New regulatory draft documents will aide manufacturers in...
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. This standard greatly increases the scrutiny for gas path devices and their required tests. This presentation will cover the required biological endpoints and the unique...
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