Module 14: Design Development and Certification of Medical Devices

17/11/2023

STERILISATION OF MEDICAL DEVICES

Learning objectives: ● TYPES OF STERILISATION PROCEDURES AVAILABLE FOR DEVICES – THE CHALLENGES OF EACH METHOD FOR MEDICAL DEVICES

● APPLICABLE ISO STANDARDS

● RISK ASSESSMENT OF STERILISATION PROCESSES

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

3

Available standards – quite a lot of them …we’ll look at them as we progress…

MORE THAN 90 RELATED STANDARDS!

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

4

2