Biological Endpoint Testing

Biological endpoint testing or biocompatibility testing forms part of the processes outlined in ISO 10993-1 – Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process.

Annex A of ISO 10993-1 details the biological endpoints that need to be considered based on the contact type and contact duration of the Medical Device in question. Annex A of ISO 10993-1 categorises device contact type as detailed below:

The Medical Devices are then further categorised by contact time: Limited < 24 hours, Prolonged >24 hours to 30 days, and Permanent >30 days. For Medical Devices that are intended for repeated use, the contact time is considered to be the total time in contact over the devices lifetime, and not per individual use.

Higher risk devices such as long term implantable devices will require more endpoint assessment to confirm biological safety than a short term intact skin contacting device.

How do I know what testing my Medical Device needs?

Surface medical devices Intact Skin
Mucosal Membrane
Breached or Compromised Surface
Externally communicating medical devices Blood path, indirect
Tissue, bone/dentin
Circulating blood
Implant medical devices Tissue/bone
Blood

As detailed in ISO 10093-1, Annex A “is a framework…and is not a checklist for testing”. The diversity of medical devices means that testing may not be necessary or practicable for all endpoints identified for the device contact type and duration.

Completing a full regime of testing according to Annex A of ISO 10993-1 may not be required for all devices requiring biological evaluation. Additionally, a full regime of testing is expensive and, as this includes animal testing, it may not be ethical to perform if relevant data is available.

Patient Guard’s experts can assist you with determining the required testing for your device and through our connection with testing laboratories, can assist in managing the biological endpoint testing to ISO 10993 series and ISO 18562 series for breathing gas pathways on your behalf.

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