Customer Service:
Mon - Fri: 8:30 am - 6 pm EST
Back
Standards PDF Cover Page

 Most recent

ANSI/AAMI/ISO 13408-1:2008 (R2017)/A1:2013

Aseptic processing of health care products -- Part 1: General requirements (includes Amendment 1).

Specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process for aseptically processed health care products. The included amendment corrects spelling errors; clarifies a definition note; and replaces terms used in Table 1 and Table 2.

Available for Subscriptions Available in Packages

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought

ISO 14644-1:2015
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle conc ...
Add to cart
ANSI/AAMI/ISO 13408-2:2018
Aseptic processing of health care products -Part 2: Sterilizing filtration
Add to cart
ISO 14644-2:2015
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance ...
Add to cart
Document History
Revises:
Included in Packages
This standard is also available in these packages:
Amendments & Corrections
We have no amendments or corrections for this standard.
ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

Useful Links
CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS
2024 © American National Standards Institute (ANSI) All Rights Reserved.