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.

Details

Developed by Subcommittee: F04.15

Committee: F04

Staff Manager: Kate Chalfin

Work Item Status

Date Initiated: 09-30-2025

Technical Contact: Ralph Basile

Item: 000

Ballot:

Status: