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.
Keywords
cleanliness; validation; medical device; single use
Rationale
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.
Work Item Status
Date Initiated: 09-01-2023
Technical Contact: Jeff Rufner
Item: 000
Ballot:
Status: