Module 14: Design Development and Certification of Medical Devices

17/11/2023

STERILISATION METHODS

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

11

HEAT STERILISATION

– DRY HEAT: Not widely used for medical devices

– Heating at very high temperatures for a long time (e.g. 160°C for 2 hours)

– Used for heat-resistant products – such as metal devices or powders

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

12

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