Ethylene Oxide Sterilization Guidanceon the Application of ANSI/AAMI/ISO 11135-1
AAMI offered a new webinar series that examined the guidance that is included in the new technical information report on ethylene oxide sterilization. Based on the following industry standard and technical information report, the program provided guidance for validation and routine control of ethylene oxide sterilization processes for medical devices:
- ANSI/AAMI/ISO 11135-1:2007 — Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO TIR11135-2:2008 — Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
Those charged with the responsibility for the development, validation, and routine control of ethylene oxide sterilization can’t afford to miss this program!
PROGRAM-AT-A-GLANCE
- Introduction to ANSI/AAMI/ISO TIR11135-2:2008
- International Acceptance
- Applicability
- Part 1, Annex C
- Part 2
- Guidance – ANSI/AAMI/ISO 11135-1:2007 Annex C and ANSI/AAMI/ISO TIR11135-2: 2008
- Scope
- Normative references
- Terms and definitions
- Quality management systems
- Sterilization agent characterization
- Process and equipment characterization
- Product definition, Process definition
- Validation
- Routine monitoring and control
- Product release from sterilization
- Maintaining process effectiveness
- Annex A, Annex B
SPEAKERS
- Charles (Phil) Cogdill, Director Corporate Sterilization, Boston Scientific Corporation
Co-chair of AAMI Ethylene Oxide Sterilization Working Group and
US expert on ISO/TC 198/WG 1 on Ethylene Oxide Sterilization - Gerry O’Dell, President & Owner, Gerry O’Dell Consulting
Co-chair of AAMI Ethylene Oxide Sterilization Working Group and
US expert on ISO/TC 198/WG 1 on Ethylene Oxide Sterilization
WEBINAR CD
- $560 for webinar registrants
- $760 for non-registrants
- Includes handout material and CD
- Please note: Domestic and International shipping rates apply.
THREE WAYS TO PURCHASE:
- Phone – 1-877-249-8226 or 240-646-7031 to order with a credit card
- Fax - Select and download the order form and fax to 240-396-5781
- Mail - Select and download the order form and mail with payment to:
EO Sterilization Webinar Series CD Package
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For
registration questions, please contact AAMI's Customer Service Center at 1-800-373-3174.