Medical Device Biocompatibility – Toxicological / Biological Safety Assessments

Given the variety of medical devices, ISO 10993 provides guidance on recommended biological endpoints to assess, based on how the medical device interacts with the patient. For example, the device may interact (“nature of body contact”) via surface contact mucosal, externally communicating blood path indirect, or implant. Duration of contact also must be considered in terms of contact duration A (<24 hours), B (beyond 24 hours; up to 30 days), or C (beyond 30 days).

This article focuses on how to handle situations where deviating from recommended testing may be desired, either due to timing or a desire to leverage prior biocompatibility and periphery data in support of a biological safety assessment. In these cases, a biological safety / toxicological assessment is warranted.

The key takeaway here is that biocompatibility is risk based. While ISO 10993-1 provide guidance on recommended testing, alternative approaches — such as combining predicate device information with other internal and external data — or a mixture of leveraged data and testing can be applied to proving biocompatibility.

Unlike standard biocompatibility testing, biological safety or toxicological assessment is fluid, and its approach varies depending on the available information. Even with the same available information, there may be more than one approach to assessing biocompatibility for your finished product.

Author(s) Source
Song M MedDevice Online, 26.02.2020
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