I had responded earlier directly to Zoya, but must comment here.
While ISO-10993 and (for the US) the G-95 Blue book provide tables for biocompatability test selection, the interpretation of what actual tests need to be perform - especially for an implanted device. An adequate L&E study with expert risk assessment and a real subchronic toxicity study with evaluation of systemic toxicity indicators (body weights, clinical chemistry, hematology, potential target organ weights and histopathology) with adequate numbers of animals are now expectations - device world biocompatability is becoming much more like drug world safety assessment.
-------------------------------------------
Shayne Cox Gad PhD, DABT, ATS
Principal
Gad Consulting Services
Cary NC
United States
-------------------------------------------
Original Message:
Sent: 07-12-2012 02:29
From: Pierre Geens
Subject: biological, evaluation
Dear Zoya
ISO10993 provides you with a matrix for decision of which test needs to be performed depending on the characteristics of your implant.
You may also find an interpretative guidance from FDA here :
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm
Hope it helps
Best regards
Pierre
-------------------------------------------
Pierre Geens
QA/RA Manager
Istar Medical
Isnes
Belgium
-------------------------------------------
Original Message:
Sent: 07-11-2012 03:25
From: Zoya Lee
Subject: biological, evaluation
Hello,
We need to perform the biological risk eveluation for the medical device based on the existing biosafety data and justify the set of test we need to perform or to omit. Can anybody advise the company may perform this?.
-------------------------------------------
Zoya Lee
RA
Degania Silicone Ltd
Israel
-------------------------------------------