Work Item
ASTM WK87727

New Guide for Establishing cleanliness limits for single use medical devices

1. Scope

This standard will provide guidance to medical device manufacturers for establishing acceptance limits for residual manufacturing residues on single use medical devices. It is not intended to establish limits on reprocessed medical devices.


cleanliness; validation; medical device; single use


This work item came out of the discussion from the May 2023 workshop on establishing limits in medical device cleanliness assessment, where it was a recognized gap in our standards. It will be used by medical device manufacturers, testing laboratories, and regulatory agencies.

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: F04.15

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 09-01-2023

Technical Contact: Jeff Rufner

Item: 000