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Biological Evaluation
BioTop Medical supports the legal manufacturer of the device with the planning of the device biological safety assessment and the writing of an objective and compliant report, following the standard EN ISO 10993-1.
The purpose of the Biological Evaluation is to assess and demonstrate that device parts that come in contact with body and tissues are designed and manufactured from materials or substances that are compatible. This needs to take into account the type, duration and frequency of the contact. This can be a challenging task if one is not familiar with the applicable standards.
Part I of the standard EN ISO 10993 provides a systematic approach to perform a biological evaluation within a risk management process. This evaluation takes into account the precise identification of the materials used in the device and during the manufacturing of the device, an assessment of the impact of the manufacturing process on the biological safety, the evaluation of the existing clinically relevant data of these materials and, if the data is non-existent or insufficient, the biocompatibility testing of the device.
One of our objectives in these evaluations is to avoid performing unnecessary testing, both for animal welfare and time to market. While in the past the standard might have been seen as a “checklist” for which clinical endpoints need to be tested, this is not the case in the European Union. However, our experiences with the FDA show that testing may still be preferred by the authorities over rationales in some cases. In either case, our objective is to make the biological evaluation process as smooth as possible.