Module 14: Design Development and Certification of Medical Devices

17/11/2023

AUTOCLAVING

– Suitable for objects and materials that can tolerate humidity, high pressure, high temperatures, such as – Surgical instruments – Semiconductors – up to 125°C – NOT suitable for many other types of component, e.g. batteries: – exposing embedded batteries to high temperatures significantly reduces their lifetime – memory devices that use floating-gate technology, such as EEPROMS

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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CHEMICAL - STERILISING GASES

ETHYLENE OXIDE (ETO) [ISO 11135: 2014 / A1: 2019] – Does not involve high temperatures / high humidity – Slower than STEAM – due to aeration stage: can range from hours to days

– Inherently hazardous! – Flammable – Carcinogenic - residues

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

20

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