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医疗器械的测试标准

医疗器械的测试标准
标准号 描述
ASTM F2267 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.
ASTM F2345 These test methods cover the evaluation of the static and cyclic fatigue strength of ceramic modular femoral heads, mounted on a cone as used on the femoral stem of the total hip arthroplasty.
ASTM F2458 This test method covers a means for comparison of wound closure strength of tissue adhesives used to help secure the apposition of soft tissue. With the appropriate choice of substrate.
BS 3531-23.1:1991, ISO 9585:1990 Implants for osteosynthesis. Bone plates. Method for determination of bending strength and stiffness
BS ISO 8009-5:1996 Reusable rubber contraceptive diaphragms. Determination of tensile properties.
BS ISO 8009-7:1985 Reusable rubber contraceptive diaphragms. Determination of compression resistance of coil spring and flat spring diaphragms.
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