WK87727 - New Guide for Establishing cleanliness limits for single use medical devices

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.

Details

Developed by Subcommittee: F04.15

Committee: F04

Staff Manager: Kate Chalfin

Work Item Status

Date Initiated: 09-01-2023

Technical Contact: Benjamin Grosjean

Item: 000

Ballot:

Status:

New Guide for Establishing cleanliness limits for single use medical devices

1. Scope

Keywords

Rationale

Details

Work Item Status

Related

New Guide for Establishing cleanliness limits for single use medical devices

1. Scope

Keywords

Rationale

Details

Work Item Status

Related