Module 14 2022

22/03/2022

STERILISATION

ISO 14937: 2009 - Introduction: A sterile medical device is one that is free of viable microorganisms.

The purpose of sterilisation is to inactivate the microbiological contaminants and transform a non-sterile medical device into a sterile one.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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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

6

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