This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
ISO/TS 22911:2016 concerns animal tests relevant to the functional assessment of dental implant systems, using both macroscopic and microscopic parameters. It is intended for use only when risk analysis indicates a need for additional information that only animal testing can provide. ISO/TS 22911:2016 is not intended to provide information on the mechanical strength of implantable materials themselves, but rather a qualitative evaluation of the implant-bone interface.
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