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2013 to Be a Big Year for Biocompatibility; Nelson Labs Participates in Potential Updates
Date:9/16/2013

three new updates were released.

Sensitization and Irritation – The European Center for the Validation of Alternative Methods (ECVAM) performed a validation for an in vitro irritation test for cosmetics to replace the rabbit irritation test. Nelson Laboratories is participating in the study to see if the validation will apply to medical devices in a three-phase process. A similar process will take place after ECVAM completes a similar validation for sensitization.

Systemic Toxicity – A new test will look at chemicals that are systemic, which is more concerning to toxicologists than localized toxicity. The goal is to find ways to become more efficient when looking at polar and non-polar extracts with toxicity studies.

Threshold of Toxicological Concern (TTC) – The working group is working to write a document that uses the concepts of TTC with medical devices in which you look at the chemicals coming off of a device and analyze them using safety information. This will be a key focus of the ISO 10993 working group leading up to the next meeting in Japan.
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Replacement of Rabbit Irritation Test

Nelson Laboratories is currently participating in round-robin test validations involving several different labs to demonstrate that medical device extracts can illicit the same predictive response with the irritation tests as those conducted by ECVAM. If the tests are successful, the in vitro tests can potentially become more efficient, user fewer or no animals, and save costs and time. FDA currently does not accept the test for medical devices saying there is no proof that extractions can elicit a response. FDA approval will depend on the round robin testing.

As an active participant in each of these biocompatibility initiatives, Nelson
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