ANSI/AAMI ST 67-2003
Sterilization of Health Care Products - Requirements for products labeled "STERILE"

Standard No.

ANSI/AAMI ST 67-2003

Release Date

2003

Published By

American National Standards Institute （ANSI)

Latest

ANSI/AAMI ST 67-2003

Scope

Establishes requirements and provides guidance for the selection of an appropriate Sterility Assurance Level (SAL) for terminally sterilized medical devices labeled "sterile." Also establishes acceptance criteria for maximum contamination rates for aseptically-filled products labeled "sterile."

ANSI/AAMI ST 67-2003 history

• 2003 ANSI/AAMI ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"