Sterilization of Medical Devices

Sterile devices are free of viable microorganisms and 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 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; and
• Maintaining sterility over time with appropriate sterile barrier systems

This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

Please note that delegates will require access to copies of ISO 11135 and ISO 11137-1 in order to take part in the exercises. If you do not already have access to these through your organisation, please see below the ways to acquire them:

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

ISO 11137-1 - https://www.iso.org/standard/33952.html and amendment at https://www.iso.org/standard/72106.html

These standards are also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.