Sara,
Start with ISO 10993-17 which provides a risk management model for estimation of safe limits.
The ISO committee is currently working on expanding this to more fully embrace Thresholds of Toxicological Concern - drawing on
ICH M7 guidance.
Arthur
------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com------------------------------
Original Message:
Sent: 02-Sep-2019 21:40
From: Anonymous Member
Subject: Extractables and Leachables
This message was posted by a user wishing to remain anonymous
Hi
Can you please tell me if there are any guidelines of Extractables and Leachables that would provide you with a cut off limit?
Thank you
Sara