Work Item
ASTM WK75646

Revision of F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices


This standard is coming up for renewal, and there is a desire to make this standard in synch with ISO 19227 and address risk assessment.


Developed by Subcommittee: F04.15

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 01-29-2021

Technical Contact: Randall Thoma

Item: 002

Ballot: F04 (21-09)

Status: Will Reballot Item

Item: 006

Ballot: F04 (22-04)

Status: Ballot Item Approved

Item: 010

Ballot: COS (22-09)

Status: Ballot Item Approved