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

 Historical

ANSI/AAMI/ISO TIR13004:2013

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD

Describes a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10-6 or less for radiation sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

Available for Subscriptions

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

Others Also Bought

ANSI/AAMI/ISO 11737-1:2006 (R2011)
Sterilization of health care products - Microbiological methods - Part 1: Determination of the population of microorganisms ...
Add to cart
AAMI TIR33:2005
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method V ...
Add to cart
NSF/IPEC/ANSI 363-2014
Practices (GMP) for Pharmaceutical Excipients
Add to cart
Document History
Revised By:
Included in Packages
This standard is not included in any 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.