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

 Most recent

ONORM EN ISO 11137-2:2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

In the present part of ISO 11137, procedures for determining the minimum dose, which is necessary to meet a defined requirement for sterility, as well as procedures for confirming the application of 25 kGy or 15 KGY as a sterilization dose to achieve a level of sterility, SAL, SAL, SAL -6) defined. This part of ISO 11137 also determines review procedures for the sterilization dose to prove the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for determining the sterilization dose and the checks of the sterilization dose.

Available for Subscriptions

Content Provider
Austrian Standards Institute [on]

Document History
Revises:
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.