Module 14: Design Development and Certification of Medical Devices

17/11/2023

STERILISATION

ISO 14937: 2009 - Introduction: “Adventitious microbiological contamination of a medical device prior to sterilization should be minimized.

….Even so, medical devices could, prior to sterilization, have microorganisms on them, albeit in low numbers. Such medical devices are non-sterile ”

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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STERILISATION

ISO 14937: 2009 ● there is always a finite probability that a microorganism might survive regardless of the extent of treatment applied. – probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. ● Sterility of any one medical device cannot be guaranteed – Assessment is based on probability of a viable microorganisms being present

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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