Module 14: Design Development and Certification of Medical Devices

17/11/2023

[with thanks to MDS Nordion, Canada]

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

35

GAMMA STERILISATION

● STERILISATION – TYPICALLY TAKES PLACE AT ELEVATED ROOM TEMPERATURE AND NORMAL ATMOSPHERIC PRESSURE

MEDICAL DEVICE SOLUTIONS AND GELS: TYPICAL DOSE: NLT 25 to NMT 38 KGy

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

36

18