Module 14: Design Development and Certification of Medical Devices

17/11/2023

STEAM moist heat sterilisation (ISO 17665-1:2006)

● Destroys microorganisms by the irreversible coagulation and denaturation of enzymes and structural proteins

Various processes available, e.g.: – Saturated steam venting systems – Saturated steam active air removal systems – Air stream mixtures – Water spray – Water immersion

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

13

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

14

7