The Medical Devices Introductory Course 2020

Terms & Definitions

Safety •Freedom from unacceptable risk

There can be no absolute safety: some risk will remain, defined as residual risk. Therefore, a product, process or service can only be relatively safe. Safety is achieved by reducing risk to a tolerable level, defined as tolerable risk. Tolerable risk is determined by the search for an optimal balance between the ideal of absolute safety and the demands to be met by a product, process or service, and factors such as benefit to the user, suitability for purpose, cost effectiveness, and conventions of the society concerned.

ISO/IEC Guide 51: Safety Aspects: Guidelines for its inclusion in standards

The Organisation for Professionals in Regulatory Affairs

Terms & Definitions

Residual risk •Risk remaining after risk control measures have been taken

Risk control •Process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels

The Organisation for Professionals in Regulatory Affairs