EN ISO 7405 Dentistry - Test for Biocompatibility of Medical Devices

Medical Device Tests

EN ISO 7405 Dentistry - Test for Biocompatibility of Medical Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 7405 testing. This standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry.

EN ISO 7405 Dentistry - Test for Biocompatibility of Medical Devices

It includes testing pharmacological agents that are an integral part of the device under test. This standard does not cover the testing of materials and devices that do not come into direct or indirect contact with the patient's body.

For the purposes of this standard, the classification of medical devices used in dentistry is derived from ISO 10993-1. If a device or material can be placed in more than one category, stricter testing requirements will apply. For multiple exposures, the potential cumulative effect should be taken into account when deciding which category to place a device in, taking into account the time period during which these exposures occur.

These devices include dental implants and other dental devices that are partially or fully embedded in one or more of the following:

  • Soft tissue, subperiosteal implants and subdermal implants;
  • Bone, endosteal implants and bone substitutes;
  • pulpodentinal system of dental endodontic materials;
  • Any combination of these, transosteal implants.

EUROLAB assists manufacturers with EN ISO 7405 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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