ANSI/AAMI/ISO 13408-7:2012
Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products

Standard No.

ANSI/AAMI/ISO 13408-7:2012

Release Date

2012

Published By

American National Standards Institute （ANSI)

Latest

ANSI/AAMI/ISO 13408-7:2012

Scope

Specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of atypical medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to AAMI/ISO 13408-1 cannot be applied.

ANSI/AAMI/ISO 13408-7:2012 history

• 2012 ANSI/AAMI/ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products