In order to be commercialized, biomedical devices must undergo a series

of standardized tests. Biocompatibility tests must follow the guidelines of the

ISO 10993-1: Biological Evaluation of Medical Devices -- Part 1: Evaluation and
testing within a risk management process. According to this standard, each
biomedical device falls under one specific category, and for each, different tests
may be needed. All test results must fall within a certain range stipulated in the
ISO, and failure to do so prevent the device to receive market approval.

The devices are separated by their type, nature of the body contact and
the exposure time in the body. Since the cochlear implant consists of two main
components, one residing inside the body, and the other worn outside, they
should be analyzed and tested separately, and under different conditions.
Information regarding the categorization can be deducted from the ISO, and is
also available in the Summary of Safety and Effectiveness Data document for
the product, available on the FDA website, for example.

First, the implant itself, that is, the intracochlear electrode array, is
categorized as an implant device in direct contact with tissue or bone, and with
permanent contact duration. In this category the following tests are necessary:

 ISO 10993-3 – Genotoxicity;

 ISO 10993-5 – Cytotoxicity;
 ISO 10993-6 – Implantation;
 ISO 10993-10 – Sensitization; Irritation or Intracutaneous Reactivity;
 ISO 10993-11 – Systemic Toxicity (acute); Subacute and Subchronic
Toxicity.

As for the external components, which are the sound processor and
remote assistants, these are characterized as surface devices in permanent
contact with skin. For this category of medical devices, the following
biocompatibility tests must be performed:

 ISO 10993-5 – Cytotoxicity;

 ISO 10993-10 – Sensitization; Irritation or Intracutaneous Reactivity.

Finally, since sterilization by ethylene oxide (EtO) is employed for such

implants, it must follow ISO 10993-7 - ETO Residual Safety

For this product, all tests had already been performed on a previous
cochlear implant series (CI24RE) by the same company, and given that no
changes in the manufacturing materials, processes, or equipment were
observed, the same biocompatibility tests could be applied to the Cochlear
Nucleus® Hybrid™ L24 Cochlear Implant System. However, since a newer
version of the ISO 10993 was used for the later, all changes in the standard had
to be considered and justified in the tests.