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

 Most recent

ANSI/AAMI/ISO 13408-3:2006 (R2015)

Aseptic processing of health care products - Part 3: Lyophilization

Specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.

Available for Subscriptions Available in Packages

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

Others Also Bought

ANSI/AAMI/ISO 10993-7:2008 (R2012)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Add to cart
ANSI/AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
Add to cart
ANSI/AAMI/ISO 13408-1:2008 (R2017)/A1:2013
Aseptic processing of health care products -- Part 1: General requirements (includes Amendment 1).
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.