ISO/FDIS 10993-1

This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO14971.
This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either:
).
This document can be useful to support clinical or usability evaluations of medical devices. For example, a biological evaluation is a pre-requisite for conducting a clinical trial. This means that principles outlined in this document can be applied to the evaluation of prototype or development stage devices, as well as to finished medical devices.
Other parts of the ISO10993 series cover specific aspects of biological evaluation, such as chemical characterization, biological testing, sample preparation, animal welfare and toxicological risk assessment.
For some types of medical devices, specific requirements from other standards (outside the ISO10993 series) can be considered with a justification for the approach taken if there are differences between the requirements of the ISO10993 series and those provided in other standards. For example, the ISO18562 series provides specific requirements for biological evaluation of breathing gas pathway medical devices and ISO7405 provides specific requirements for biological evaluation of dental devices.
The evaluation of risks related to infectious agents [e.g. bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents] is not within the scope of this document.
NOTE1 The evaluation of bacterial endotoxins is addressed by ISO11737-3.
NOTE2 The evaluation of risks related to viruses, TSE agents and other pathogens originating from materials of animal origin is addressed by the ISO22442 series.