Module 14: Design Development and Certification of Medical Devices

17/11/2023

FACTORS INFLUENCING CHOICE OF MATERIALS

STERILISATION, DISINFECTION AND CLEANING ● Effect of biocides / sterilisation processes on device materials – alcohol, bleach and peroxide

– sterilisation methods including autoclaving, gas plasma and Ethylene oxide (EtO). – Repeated exposure can cause many plastic medical devices to craze or crack, lose critical properties or change colour.

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

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FACTORS INFLUENCING CHOICE OF MATERIALS

STERILISATION, DISINFECTION AND CLEANING ● Metals – resistance to harsh cleaners and various sterilisation techniques, – increases weight and design restrictions. ● Semi-crystalline polymers -polypropylene, polyethylene, polyamides – lighter and easily moulded, better chemical resistance than amorphous polymers - polycarbonate and acrylonitrile-butadiene-styrene.

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

12

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