The training provides guidance on:

Dose determination for radiation  sterilization per ISO 11137-2;

Sterilization of health-care products;

Radiation; 

Requirements for the development, validation and routine control of a sterilization process for medical devices.

The proposed course programmes are as follows:

  1. Dose determination requirement per ISO 11137-2
  2. Writing protocol
  3. Microbiological study of medical device before and after dose determination
  4. Result analysis and Case study
  5. Writing report
  6. Quarterly Review and Dose Audit

 

FOR WHOM:

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

MY | Dose Determination for Sterilization ISO 11137-2

Language : English
Location Price
Klang Valley
Klang Valley Book