Module 14: Design Development and Certification of Medical Devices

17/11/2023

GAMMA STERILISATION

● EFFECTS – Besides affecting living cells, gamma radiation affects polymers and semiconductors. – The effect on electronics depends on the dose and dosage rate. In the extreme, a total ionisation greater than 5000 rads (0.05 KGy) in silicon delivered over seconds to minutes degrades semiconductor materials for long periods. – In practice, the medical industry, tend to sterilise instruments and products at ionization levels in the range of 250 to 500 rads range (0.0025 – 0.005 KGy), where specifically design semiconductor devices can reliably operate. – under the right conditions, gamma ray sterilisation can be used for objects containing compatibly-designed semiconductor devices.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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Labelling tells you when it’s been irradiated

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

38

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