Your Shopping Cart
By using this site you agree to our use of cookies. Please refer to our privacy policy for more information. Close
EO Sterilization Control and Validation – Necessity and Requirements
- Date: March 18, 2010
- Source: Admin
Sterilization validation is a topic of immense relevance as it pulls many audit observations from the FDA and international regulatory bodies. For medical device sterilization, comparing to other modes such as steam sterilization and etc, EO works in relatively low pressure temperature and therefore, has been regarded as one of the most excellent and useful method of medical device sterilization.
What is EO?
EO or Ethylene Oxide was originally used for sterilizing spices but now it has extensively been used for sterilization of medical devices. Arrival of plastics and disposables to the device field prompted the use of EO sterilization.
Validating EO Sterilization
In comparison to other available methods of sterilization, EO is a lengthy and at the same time, a complicated process. Though EO sterilization has been used for sterilizing medical devices for last 50 years but its involvement with too many variables makes the process complicated. Hence, validating the process of EO sterilization becomes important for ensuring the quality and functionality of the medical device.
Important Standards for Validating and Controlling EO Sterilization
Standards that have been developed to validate and control the sterilization process are mostly driven by AAMI and ISO. A few of the important standards
- ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
- AAMI/ISO 11137 Sterilization of healthcare products —Requirements for validation and routine control — Radiation sterilization
- EN550 (European standard) Sterilization of medical devices Validation and routine control of ethylene oxide sterilization
To know more about how EO sterilization works, the equipment involved in the process, major issues with product sterilization via EO, and the validation requirements, and about how to control and monitoring routine process to maintain the process effectiveness, join the webinar Requirements of validation and control of EO Sterilization organized by Compliance Online.
Compliance Trainings
Chief Compliance Officer: What does it take to do the job? The Organization's and CCO's Responsibilities
By - Laura S Hargraves
On Demand Access Anytime
By - Laura S Hargraves
On Demand Access Anytime
Structuring Physician Practice Acquisitions: Key Stark Law Considerations
By - Joseph Wolfe
On Demand Access Anytime
By - Joseph Wolfe
On Demand Access Anytime
Compliance Standards
Best Sellers
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
By: Miles HutchinsonAdd to CartPrice: $249
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
San Francisco, CA | Aug 6-7, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 18-19, 2020
-
Los Angeles, CA | Aug 20-21, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 25-26, 2020
-
Virtual Seminar | Jun 10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | Jul 6-7, 2020
-
San Francisco, CA | Oct 22-23, 2020
-
Virtual Seminar | Jul 9-10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | June 3-4, 2020
-
Miami, FL | Jul 29-31, 2020
-
Virtual Seminar | Jun 17, 2020
-
Provider: ANSIAdd to CartPrice: $142
- Add to Cart
- Add to Cart
- Add to Cart
-
Provider: ANSIAdd to CartPrice: $120
-
Provider: ANSIAdd to CartPrice: $250
-
Provider: SEPTAdd to CartPrice: $299
- Add to Cart
-
Provider: Quality-Control-PlanAdd to CartPrice: $37
- Add to Cart
-
Provider: At-PQCAdd to CartPrice: $397
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
You Recently Viewed