Ethylene Oxide Residuals — Guidance
on the Application of ANSI/AAMI/ISO 10993-7:2008

This webinar examines the second edition of ANSI/AAMI/ISO 10993-7:2008 — Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals.  The webinar highlights changes to the 2008 version of ANSI/AAMI/ISO 10993-7 with specific focus on how to test and validate the ethylene oxide residuals for compliance with the international requirements.  Participants hear questions and answers with one of the co-chairs that represents the US on the ISO sub-TAG responsible for the development and revision process for the international ethylene oxide residuals standard.  At the conclusion of the program, attendees will have gained knowledge that will assist in the operation of ethylene oxide sterilization within their organization.

PROGRAM

Introduction to AAMI/AAMI/ISO 10993-7:2008
   
    Application of ISO 10993-17:2002 to establishing allowable limits for ethylene oxide (EO) residuals
    Allowable limits
    Applicability
    Determination of EO and ethylene chlorohydrin (ECH) residuals
   

- Selecting the right extraction method
- Simulated use extraction
- Exhaustive extractions
- Calculating results
- Reporting result
    Products release
    - Dissipation curves
- Maintaining process validation


SPEAKERS

WHO SHOULD ATTEND
This webinar is designed for sterilization engineers, scientists, quality assurance professionals, regulatory affairs professionals, and any other individuals with sterilization responsibility.

WEBINAR CD - Includes pdf of handout materials and webinar recording on CD. Please note: Domestic and international shipping rates apply.

THREE WAYS TO ORDER

  1. Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
  2. Fax - Select and download the order form and fax to 240-396-5781 .
  3. Mail - Select and download the order form and mail with payment to:

    EO Residuals Webinar CD Packet
    AAMI Publications
    PO Box 0211
    Annapolis Junction, MD 20701-0211

QUESTIONS?
For questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031.