This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971.


This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either:


—     a patient's body during intended use or reasonably foreseeable misuse; or


—     the body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks).


Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with:


—     constituents of a medical device; and


—     tissue-device interactions (including physical effects).


The biological evaluation specified in this document can address the biological safety of the medical device, considering the life cycle from design and development through initial use of the finished medical device to final decommissioning or withdrawal from use. The biological evaluation considers both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle. However, the evaluation of risks related to environmental impacts of decommissioning of medical devices are not within the scope of this document. This document does not mandate re-testing of medical devices that are already on the market and ha...