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

 Historical

ISO/TS 11135-2:2008

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1

ISO/TS 11135-2:2008 provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification.

This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.


Content Provider
International Organization for Standardization [ISO]


Others Also Bought

ISO 11135-1:2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and ...
ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 14971:2007
Medical devices - Application of risk management to medical devices
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