1.1 This test method assesses metal or other ions released from single-use, metallic, implantable medical devices, or components thereof, by exposing the device to solutions simulating the in-vivo environment and temperature in a container for a predetermined time frame with regular sampling at adequate intervals. Examples of device types that may be evaluated by this test method include, but are not limited to: cardiovascular devices, endovascular devices, and orthopedic implants. Devices which are to be partially implanted, but in long-term contact within the body (such as external fixation devices) may also be evaluated using this method.

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Published:

02/01/2019

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6

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1 file , 90 KB