ANSI/AAMI/ISO 13408-2:2003
Aseptic Processing of health care products - Part 2: Filtration

Standard No.

ANSI/AAMI/ISO 13408-2:2003

Release Date

2003

Published By

American National Standards Institute （ANSI)

Status

Be replaced

Replace By

ANSI/AAMI/ISO 13408-2:2018

Latest

ANSI/AAMI/ISO 13408-2:2018

Scope

Specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.

ANSI/AAMI/ISO 13408-2:2003 history

• 1970 ANSI/AAMI/ISO 13408-2:2018 Aseptic processing of health care products—Part 2: Sterilizing filtration
• 2003 ANSI/AAMI/ISO 13408-2:2003 Aseptic Processing of health care products - Part 2: Filtration