Revision:2017 Edition, 2017

Published Date:January 2017

Status:Active, Most Current

Document Language:English

Published By:Association for the Advancement of Medical Instrumentation (AAMI)

Page Count:38

ANSI Approved:Yes

DoD Adopted:No

This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.