Standard Guide for Designing Reusable Medical Devices for Cleanability

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-01-2019

Publisher

American Society for Testing and Materials

1.1This guide is intended to provide manufacturers of reusable medical devices design feature guidance to minimize debris retention after use and increase ease of removal of contaminants and cleaning product residuals from devices during cleaning/rinsing and also prepare for subsequent processing steps (for example, sterilization or disinfection).

1.2This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.3This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Committee	F 04
DocumentType	Guide
Pages	7
ProductNote	THIS STANDARD ALSO REFERES TO : ANSI/AAMI/ISO 11139:2018,ANSI/AAMI/ISO 17665-1:2006(R)2013,ANSI/AAMI/ISO 17664:2017
PublisherName	American Society for Testing and Materials
Status	Current