Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Most recent

ANSI/AAMI ST67:2019

Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”

This standard establishes requirements, guidance and a risk framework for identification of acceptable approach(es) for assurance of sterility and for selection of alternative SAL(s) or aseptic processing for health care product that cannot be terminally sterilized to achieve an SAL value of 10 to the -6


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


Others Also Bought

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified ...
Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans ...
Document History
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.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS