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Note: Devices subject to Clause 5.3.2 may require additional testing beyond that which is specified in Clause 5.3.2 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
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Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators).Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices.Standard Specification and Test Methods for Metallic Medical Bone Screws.Standard test method for cyclic fatigue testing of metal tibial tray components of unicondylar knee joint replacements.Standard test methods for static and dynamic characterization of spinal artificial discs.
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