Module 14: Design Development and Certification of Medical Devices

17/11/2023

STERILISATION

● ISO 14937: 2009 - Sterilization of health care products: General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices..

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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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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