ANSI/AAMI SW96:2023
Standard for medical device security - Security risk management for device manufacturers

Standard No.

ANSI/AAMI SW96:2023

Published By

American National Standards Institute （ANSI)

Latest

ANSI/AAMI SW96:2023

Scope

Provides requirements on methods to perform security risk management for a medical device in the context of the safety risk management process required by ISO 14971. This document is intended to be used in conjunction with AAMI TIR57 and AAMI TIR97.

ANSI/AAMI SW96:2023 history

• 1970 ANSI/AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers