MY | Performance Qualification of ETO Sterlization Process for Medical Devices (ISO 11135:2014)

The training provides guidance on conduct Performance Qualification for ETO sterilization per ISO 11135:2014 Sterilization of health-care products – Ethylene oxide- Requirements for the development, validation and routine control of a sterilization process for medical devices.

The proposed course programmes are as follows:

1. Performance qualification requirement per ISO 11135:2014
2. Writing protocol
3. Microbiological study of medical device before and after sterilization
4. Result analysis and Case study
5. Writing report
6. Yearly Review and Audit

For Whom:

This course is designed for individuals involved in the performance qualification, maintaining and monitoring of QMS at ETO sterilization facility for medical device and also medical device manufacturers that require ETO sterilization for their sterile products.