Work Item
ASTM WK78356

Revision of F1904-14 Standard Practice for Testing the Biological Responses to Particles in vivo

Keywords

None Provided

Rationale

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.

Details

Developed by Subcommittee: F04.16

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 09-20-2021

Technical Contact: Simona Bancos

Item: 003

Ballot: F04 (21-12)

Status: Will Reballot Item

Item: 005

Ballot: F04 (22-02)

Status: In Balloting