Work Item
ASTM WK86632

New Guide for medical device schematics to aid in cleaning

1. Scope

The purpose of this standard is to have the medical device manufacturer provide a schematic of the device and materials that clearly identifies the layout of the device to facilitate effective cleaning by the healthcare facility


cleaning, schematic, medical device


Reusable medical devices are an integral part of healthcare
To ensure patient safety it is vital the device is reprocessed efficaciously every time
To allow the professionals tasked to meet the required reprocessing standard at each step, the professionals need to have the knowledge about the device, to formulate a plan to manually clean, high level disinfect, sterilize and store the device to agreed reprocessing standard every time.
Many reusable devices have internal channels or features that are not visible. This increases the risk that the reprocessing of the device will be compromised increasing the risk to patients and staff

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: 06-02-2023

Technical Contact: Rod Galantai

Item: 000