Work Item
ASTM WK78014

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


Microbial testing from ASTM E2314, a document which will be retired at a later time will be placed in ASTM F3438. The information for microbial testing is important to add in ASTMF3438 as they are some manufacturers that still use microbial reduction as cleaning verification test in the medical device industry. ASTM E2314 is quite outdated so i will update the information and add in ASTM F3438.


Developed by Subcommittee: F04.15

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 08-12-2021

Technical Contact: Alpa Patel

Item: 002

Ballot: F04.15 (22-01)

Status: Will Reballot Item

Item: 006

Ballot: F04 (22-05)

Status: Negative Votes Need Resolution