Revision is needed to update current in vivo testing practices for medical device debris and degradation products, based on the recently accumulated clinical and experimental evidence which provides a mechanistic understanding of respective biological responses and improved options for testing methods. The current draft includes major changes throughout the entire document. The revision includes clarification of the scope of Practice F1904 and restructuring of the entire standard practice and its component sections.
Date Initiated: 09-20-2021
Technical Contact: Simona Bancos
Item: 008
Ballot: F04 (22-04)
Status: Withdrawn From Balloting
Item: 003
Ballot: F04 (21-12)
Status: Will Reballot Item
Item: 005
Ballot: F04 (22-02)
Status: Will Reballot Item
Item: 002
Ballot: F04 (22-07)
Status: In Balloting