ANSI/AAMI/IEC 62304,Ed.1:2006
Medical device software - Software life-cycle processes

Standard No.

ANSI/AAMI/IEC 62304,Ed.1:2006

Release Date

2006

Published By

American National Standards Institute （ANSI)

Scope

Defines the life-cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life-cycle processes.