An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices Training Course

Overview

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization by Ethylene Oxide is important and expected when demonstrating conformity with the regulations.

These requirements have been supported by a portfolio of standards on:

• Designating products as sterile;
• Validating and routinely controlling the sterilization process;
• Determining whether the sterilization process has any adverse effect on the devices; and
• Maintaining sterility over time with appropriate sterile barrier systems

This course provides an introduction to these regulatory requirements as they relate to EO sterilization and how manufacturers may demonstrate compliance. 

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits in Attending

• Gain an overview of medical device sterilization by EO
• Understand the principles of EO validation for medical devices
• Learn the regulatory requirements for EO sterilization and how to comply
• Gain an awareness of supporting standards and their interrelationships

Who Should Attend

• Microbiologists and sterilization professionals
• Quality Management System (QMS) specialists
• Regulatory Compliance specialists
• Internal Auditors
• Regulatory and Quality professionals

Please note that delegates will require access to a copy of ISO 11135 to gain the most from this training. If you do not already have access to this through your organisation, please see below the ways to acquire it:

ISO 11135 - https://www.iso.org/standard/56137.html

This standard is also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc

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