Recently, on my company, we have started to develop a new medical device class IIb which presents a sensors that enter in contact with air flow, and a case that can be touched by the healthcare professional and we have several doubts.
We have never worked with biological evaluation plan, so we don’t completely understand the contents of this document. I was wondering if someone could share a template or an example.
Secondly, the case is manufactured externally with AISI 316 and white painting. Regarding the material, I think it is a completely studied material, and through literature justification to not perform cyto, irritation and sensitization would be sufficient. Regarding the painting I’m not so sure. Maybe chemical characterization would be needed in order to determine its chemical components, and in case there is some toxic substance over 0.01%, perform needed biocompatibility tests? Or maybe justifying a contact with the healthcare professional around 1 minute would be sufficiend to justify the low need to perform the tests?
We have never worked with biological evaluation plan, so we don’t completely understand the contents of this document. I was wondering if someone could share a template or an example.
Secondly, the case is manufactured externally with AISI 316 and white painting. Regarding the material, I think it is a completely studied material, and through literature justification to not perform cyto, irritation and sensitization would be sufficient. Regarding the painting I’m not so sure. Maybe chemical characterization would be needed in order to determine its chemical components, and in case there is some toxic substance over 0.01%, perform needed biocompatibility tests? Or maybe justifying a contact with the healthcare professional around 1 minute would be sufficiend to justify the low need to perform the tests?