Module 14 2022

21/03/2022

Pre-amble

• Biological assessment is not a tick-box process

• Rather, a qualified individual developing an evaluation programme based on the specifics of the device is required

• Purpose: to assure safety for patient or user

The Organisation for Professionals in Regulatory Affairs

5

Where to start?

Is there direct or indirect contact with tissues?

NO

YES

ISO 10993.1 does not apply

Device material identification, chemical characterisation

The Organisation for Professionals in Regulatory Affairs

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3