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

 Most recent

ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package

ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11137-2 and ANSI/AAMI/ISO 11137-3

The ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the sterilization process of medical devices. In addition to providing the requirements for the sterilization process of medical devices, this package also considers the products' environment, personnel and their hygiene, packaging / storage, sterilization doses and more to inactivate microbiological contaminants on medical devices. The ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package includes:

  • ANSI/AAMI/ISO 11137-1:2006 (R2015) and A1:2013
  • ANSI/AAMI/ISO 11137-2:2013 (R2019)
  • ANSI/AAMI/ISO 11137-3:2017
  • ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package includes:

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


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