ISO 7405 Dentistry - Test Standard for Evaluation of Biocompatibility of Medical Devices Used in Dentistry

This standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry. 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.

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