Work Item
ASTM WK84154

New Practice for Standard Practice to Stress Liquid Chemicals to be Reused in the Manual Disinfection of Heat sensitive Medical Devices

1. Scope

1.1 This practice is designated to simulate the soil loading that may occur when a liquid chemical is repeatedly reused in a manual bath to disinfect heat-sensitive medical devices such as endoscopes

Keywords

Use Re Use; medical devices; High Level Disinfectant

Rationale

This practice describes how to conduct a use re use study for the treatment of heat-sensitive medical devices (such as endoscopes) with a liquid chemical (such as a High Level Disinfectant). This practice fills the void of a standardized procedure that is required for the evaluation of Sterilants and High Level Disinfectants for the US FDA. This practice can also apply to EPA requirements as well.

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

Details

Developed by Subcommittee: E35.15

Committee: E35

Staff Manager: Brian Milewski

Work Item Status

Date Initiated: 11-10-2022

Technical Contact: Angela Hollingsworth

Item: 000

Ballot:

Status: