What Has Changed for EO Sterilization? A Comparison of the 1994 and 2007 Versions of ANSI/AAMI/ISO 11135-1

Ethylene oxide sterilization is a vital process for many in the healthcare industry.  Having an in-depth understanding of the changes in the standards document that provides the requirements for the development, validation, and routine control is essential for medical device manufacturers using this process.  The Association for the Advancement of Medical Instrumentation (AAMI) is pleased to offer a this webinar CD which addresses these changes to the medical device industry.   Based on 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, the webinar on CD examines the changes to the requirements and guidance that are included in the latest version of the standard. 

PROGRAM OBJECTIVES

This webinar on CD reviews the differences between the 1994 and 2007 versions of ANSI/AAMI/ISO 11135-1.  Program content examines the changes to the requirements and the guidance that is provided in the current standard.  The CD includes questions asked of and answers given by the current co-chairs that represent the United States on the ISO sub-TAG responsible for the development and revision process for the international ethylene oxide standard.  At the conclusion of the CD, attendees will gain knowledge of the differences in the new version so that they can implement the changes that may be required for their organization.

PROGRAM-AT-A-GLANCE

 
Introduction to ANSI/AAMI/ISO 11135-1:2007
  • International Acceptance
  • Applicability
  • Part 1
  • Part 2
Requirements - ANSI/AAMI/ISO 11135-1: 2007 compared to ANSI/AAMI/ISO 11135:1994
  • 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
Guidance - ANSI/AAMI/ISO 11135-1: 2007 compared to ANSI/AAMI/ISO 11135:1994
  • Annex A
  • Annex B
  • Annex C


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

Includes handout material and CD. 
 

$295 for webinar registrants
$395 for non-registrants
Please note: Domestic and international shipping rates apply.

THREE WAYS TO PURCHASE

1.
Phone - 1-877-249-8226 or 240-646-7031 to register 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:

Ethylene Oxide Sterilization Webinar CD Packet
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211

QUESTIONS?

For questions about ordering the CD, please contact AAMI's Publications at 1-877-249-8226 / 240-646-7031.

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