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Spinal implants
 

Spinal components - ASTM F2193Spinal components - ASTM F2193 Spinal implants - interconnections mechanisms and subassemblies - ASTM F1798Spinal implants - interconnections mechanisms and subassemblies - ASTM F1798 Spine Corpectomy Model - ASTM F1717Spine Corpectomy Model - ASTM F1717 Spinal cage test - ASTM F2077Spinal cage test - ASTM F2077 Spinal disc wear test - ISO 18192-1Spinal disc wear test - ISO 18192-1 Spinal implants subsidence test - ASTM F2267Spinal implants subsidence test - ASTM F2267 Nucleus replacement wear test - ISO 18192-2Nucleus replacement wear test - ISO 18192-2 Expulsion Test - PI-52Expulsion Test - PI-52 Spine corpectomy model with anterior support - ISO 12189Spine corpectomy model with anterior support - ISO 12189 Extra discal motion preserving implants - ASTM F2624Extra discal motion preserving implants - ASTM F2624 Lumbar total facet prostheses - ASTM F2694/F2790Lumbar total facet prostheses - ASTM F2694/F2790 Occipital-cervical and occipital-cervical-thoracic model - ASTM F2706Occipital-cervical and occipital-cervical-thoracic model - ASTM F2706 Spinous process plates - PI-76Spinous process plates - PI-76 Mechanical and Functional Characterization of Nucleus Devices - ASTM F2789Mechanical and Functional Characterization of Nucleus Devices - ASTM F2789 Impingement-wear testing of lumbar prostheses - ISO 18192-3Impingement-wear testing of lumbar prostheses - ISO 18192-3 Particular requirements for joint replacement implants - ISO 21534Particular requirements for joint replacement implants - ISO 21534 Impingement wear testing of total disc prostheses - ASTM F3295Impingement wear testing of total disc prostheses - ASTM F3295 Spinal Disc Static and Fatigue Test - ASTM F2346Spinal Disc Static and Fatigue Test - ASTM F2346 Spinal Cage Pre-clinical Mechanical Assessment - ISO 23089-2Spinal Cage Pre-clinical Mechanical Assessment - ISO 23089-2

Spinal Cage Pre-clinical Mechanical Assessment - ISO 23089-2

Normative References  



ISO 23089-2: Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements —Part 2: Spinal intervertebral body fusion devices

ISO 23089-2 bridges the gap between the established ASTM standards for testing intervertebral body fusion devices and the ISO series of standards. In addition, this standard lists further preclinical issues such as coatings, corrosion, and impact behavior.
Optional acceptance criteria for mechanical testing are provided, which result from previously FDA-cleared interbody fusion devices.  


Implant Testing - Spinal Cage Pre-clinical Mechanical Assessment - ISO 23089-2


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