ASTM F2475 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

The ASTM F2475 guideline provides information for determining appropriate tests for the biocompatibility of medical device packaging materials that have the potential to come into direct or indirect patient contact. This guide does not apply to secondary or tertiary packaging materials.

Compatibility of packaging materials with a medical device is a requirement of many regulatory agencies. Because most medical devices are used or implanted in, around or over the human body, the benefits of these devices must outweigh the risks.

Therefore, packaging materials that come into contact with the medical device should also be evaluated and determined to be safe for use with the human body, as it does not have a negative effect on the physical, chemical or biological properties of the device. This assessment may include both a study of experience with packaging materials and actual testing of packaging materials.

Such an assessment may conclude that no testing is necessary if the material has a demonstrable history of safe use in a particular role that is the same as that of the packaging under design.

The medical device manufacturer determines the need for appropriate testing, taking into account device/package interactions, if any. When screening information regarding the biocompatibility of the package is needed, cytotoxicity testing is typically performed from the supplier.

This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.

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