Testing Products for ASTM F382

APP-F382
Application Insight:

Bio-Simulation: Bone plates must survive millions of cycles of walking loads without snapping.

Compliant Hardware Solution

313-50-1200

This machine has been validated to meet the specific requirements of this standard.

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Regulatory & Test Details

App Id APP-F382
App Standard ASTM F382
Standard Organization ASTM
Test Type Flexure
Material Type Medical
Specimen Type Bone Plate
Industry Type Medical / Ortho
Min Force Kn 5
Max Force Kn 50
Min Spd Mm/m 0.1
Max Spd Mm/m 5
Expert Spd 0.1mm for static, Hz for fatigue.
Mach Recommend 313-50-1200
Pointer App Software N-ASTM-F382
Pointer Fixture Family G-ASTM-F382
Pointer Strain Family E-ASTM-F382

Implementation Commentary

This 4-point bend test is the primary FDA-clearance hurdle for any new orthopedic implant design.

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