ISO 10993-1 : 2018 Biological Evaluation Of Medical Devices

ISO 10993-1 : 2018 Biological Evaluation Of Medical Devices – This standard gives guidelines for the assessment of biological hazards arising from:

— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;  

— breakage of a medical device or medical device component which exposes body tissue to new or novel materials.

Specific sections read…

4.7  The biological safety of a medical device shall be evaluated by the manufacture over the whole life-cycle of a medical device.

4.8 For re-usable medical devices, biological safety shall be evaluated for the maximum number of validated processing cycles by the manufacturer.