Work Item
ASTM WK96511
Revision of F3321-25 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
Rationale
We received a comment during the last ballot period (with an affirmative ballot) with this comment and then alternative text: "The 70% extraction efficiency, while it may be common practice, may mislead some regulatory bodies and be misinterpreted as a definitive"
I promised to ballot this for consideration by the Committee.
requirement.
Work Item Status
Date Initiated: 09-30-2025
Technical Contact: Ralph Basile
Item: 000
Ballot:
Status: