Work Item
ASTM WK82095

Revision of F3438-21 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices


Revision was made to take out microbial log reduction as an option to cleaning validation as the practice is not used anymore and FDA does not accept this data.


Developed by Subcommittee: F04.15

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 06-05-2022

Technical Contact: Alpa Patel

Item: 000