Module 14: Design Development and Certification of Medical Devices

17/11/2023

ETHYLENE OXIDE STERILISATION

SUITABLE FOR: – Items that cannot be sterilised at high temperature, pressure – Due to its low +30° to +60°C temperature conditions, ETO sterilisation is well suited for medical devices with embedded electronics. – However, the vacuum may not be acceptable for embedded batteries – Also suitable for dressings etc.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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CHLORINE DIOXIDE

● AS WITH ETO…Does not involve high temperatures / high humidity

– also slower than STEAM – due to aeration stage: can range from hours to days

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

24

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