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


AAMI and ISO standards were updated and additional ASTM standards were added to the list of standards that pertained to this document. Additional information regarding how to perform Analyte validation was provided in the document to help the readers understand the requirements for validation. Other options for protein and hemoglobin assay were added to the standards for detection of analytes after a cleaning validation.


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: Will Reballot Item

Item: 000



Item: 003

Ballot: F04.15 (23-01)

Status: Negative Votes Need Resolution