EndoLab - Implant Testing Services Implant Testing

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

Particular requirements for joint replacement implants - ISO 21534

Normative References  



ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirements
ISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parameters
ISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral components
ISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral components
ISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests
ISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurement
ISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
ISO 14630: Non-active surgical implants - General requirements
ISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
 


The standard provides particular requirements for joint replacement implants. Amongst others, test services evaluating the geometrical, fatigue and wear properties of joint replacement implants are provided by EndoLab®.  

Implant Testing - Particular requirements for joint replacement implants - ISO 21534


Implant groups

Hip implants Knee implants Spinal implants Shoulder implants Finger implants Osteosynthesis Instruments Ankle implants Vascular implants Material testing Dental implants Particle analysis Elbow implants Wrist implants Exoprosthesis Consumables
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