Description

Revision:2014 Edition, 2014

Published Date:January 2014

Status:Active, Most Current

Document Language:English

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

Page Count:50

ANSI Approved:Yes

DoD Adopted:No

This part of ISO 10993 specifies strategies for risk estimation,selection of hazard identification tests and risk management, withrespect to the possibility of the following potentiallyirreversible biological effects arising as a result of exposure tomedical devices:

— genotoxicity;

— carcinogenicity;

— reproductive and developmental toxicity.

This part of ISO 10993 is applicable when the need to evaluate amedical device for potential genotoxicity, carcinogenicity, orreproductive toxicity has been established.

NOTE Guidance on selection of tests is provided in ISO10993-1.