MED Präsentationsfolien

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

Language : English
Please choose a date from the options below Please choose a date from the options below Location Price
On demand
Klang Valley
Klang Valley Book


The training provides guidance on how to 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.

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

Language : English
Please choose a date from the options below Please choose a date from the options below Location Price
On demand
Klang Valley
Klang Valley Book

Any Questions?

We are here for you.
Contact Us