Module 14: Design Development and Certification of Medical Devices

17/11/2023

ELECTRON BEAM STERILISATION (EBS)

● NO RADIOACTIVITY INVOLVED ● MUCH FASTER THAN GAMMA STERILISATION ● SUITABLE FOR LOW DENSITY PACKED DEVICES – DOES NOT PENETRATE AS DEEP AS GAMMA RADIATION

– When directed at electronic components, the electron beam can cause charge build-up (ESD) which, in turn, can cause damage. – EBS should only be used for objects containing semiconductors that are designed to specifically tolerate both the electron beam radiation level and ESD build-up.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

39

ELECTRON BEAM STERILISATION

https://www.youtube.com/watch?v=fy1RqXAQoKQ

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

40

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