Module 14 2022

24/03/2022

ISO 11607

Specific areas to consider ● Stability: the extremes of temperature / humidity that the device might experience during transport distribution, storage and handing. ● Sample size: dependent on the associated risks with the process and the device. ● Withstanding hazards: The device packaging must have a high probability of withstanding hazards and ensuring that the product reaches its intended destination without failure.

Interactive Session

The Organisation for Professionals in Regulatory Affairs

17

SHELF-LIFE vs USEFUL LIFE

FDA definitions: ● SHELF-LIFE – The term or period during which a device remains suitable for its intended use ● USEFUL LIFE: – The duration of actual use or the number and duration of repeated uses before some change results in the device’s inability to achieve its intended function. ● EXPIRATION DATE: – The termination of the shelf-life after which the device may no longer function as intended

Interactive Session

The Organisation for Professionals in Regulatory Affairs

18

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