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

 Historical

ANSI/AAMI/ISO 11135-1:2007

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Establishes requirements for validation and routine control of ethylene oxide sterilization processes for medical devices.

Available for Subscriptions

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

Others Also Bought

ANSI/AAMI/ISO TIR11135-2:2008
Sterilization of health care products- Ethylene oxide -Part 2: Guidance on the application of ANSI/AAMI/ISO 11 ...
Add to cart
ANSI/AAMI/ISO 11737-1:2006
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms ...
Add to cart
ANSI/AAMI/ISO 11607-1:2006
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems ...
Add to cart
Document History
Revises:
  • Partial revision of ANSI/AAMI/ISO 11135:1994
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.