Knowledge Base
Medical Device Testing
Medical Device Testing Standards
Keywords:
ISO 5840-1:2015, ISO 5840-2:2015, ISO 5840-3:2013, ISO 7198:2016, ISO 12417-1:2015, ISO 14708-5:2010, ISO/TS 17137:2014, ISO 25539-1:2017, ISO 25539-2:2012, AAMI TIR42, ASTM F2394-07 (2017), ASTM F2477-07, ASTM F2743-11, ASTM F3036-13, ASTM WK46148, ASTM WK60510, ASTM WK60511
Dynatek First
Keywords:
fatigue to fracture, acute particulate testing, coating durability tester, particulate analysis, photographic verification, artificial heart tester, compliance for mock vessels, optically clear mock vessels, heart valve testing, velocity flow standard, dynamic internal compliance, stent/graft durability tester
Radial Pulsatile Durability Testing, Coating Durability and Bend Testing of Stents and Stent Grafts
Keywords:
coating durability, abdominal aortic aneurysm, stents, stent grafts, endovascular devices, coated stent, particle counter, stent migration, bioabsorbable stents, polymeric stents, protocol for durability testing, test monitoring and reports, inferior vena cava (IVC)
Heart Valve Durability Testing at Dynatek’s Contract Testing Lab
Keywords:
heart valve, ISO 5840, ISO/AAMI/ASTM standards, cardiac prostheses, ISO 5840:2009, accelerated wear testing (AWT), valve durability testing, testing unstented valves, failure mode testing, cavitation
Acute Particulate Testing of Vascular Devices
Keywords:
Acute Particulate Tester, Drug-Eluting Balloon Testing, Particulate Matter Evaluation, SEM/EDX/FTIR analysis, Coating Integrity Inspection, ASTM F2394-07, particle counters, vascular device, ASTM and ISO regulations, drug-eluting, balloons, particle capture, drug coating
Custom Capabilities
Keywords:
custom solutions, startups, SolidWorks, heart valve, testing capacity, test equipment, Dynatek Labs, stent, heart valve, cardiovascular (CV) device
Sizing Matters
Correct sizing of mock vessels is crucial to the validity of a cardiovascular stent test. Dynatek mock vessels are tested and certified for compliance and wall thickness.
Acute Particulate Testing of Stents, Stent-grafts and Catheters
Dynatek Labs performs Acute Particulate Testing (US Patent # 9,453,788 B2) of a variety of vascular devices. Acute Phase Particulate Testing of vascular devices such as stents, stent-grafts, and catheters includes:
- Real-time Particulate Matter Evaluation during Deployment and Withdrawal
- Coating Integrity Inspection
Critical Criteria For Purchasing a Heart Valve Tester
Keywords:
heart valve testers, AAMI/ISO/FDA regulations, regulatory agencies, ISO/AAMI 5840-3:2013, independently tuned, closing pressure, tuned fluid oscillation, test chamber, in vivo, visual observation, pressure transducers, heart valve manufacturers
Flow-Through in Stent Radial Fatigue and Coating Durability Testers
Keywords:
radial fatigue testers, coating durability testers, mock silicone vessels, chronic fatigue, durability testing, pulsatile pressurization, flow-through, stent, mock vessel, coated stent, shed particles, drug-eluting stents, in vivo
High Speed Photographic Verification of Stent Deflection
Keywords:
international standards, stent, stent-graft, fatigue testing, vascular device, silicone mock vessel, pulsatile deflection, photographic verification, distension measurements, laser micrometry, radial fatigue, mock vessel deflection, ASTM F2477-07, in vitro
M6 Heart Valve Tester Demonstration
Keywords:
heart valve tester, mechanical valves, testing chamber, pressure curve, test sections, feasibility test, custom test sections
Particle Counters for Stent Testers
Keywords:
ISO, ASTM, particulate, drug-eluting, stent, particulates shed, intravascular, particles, particle counter, shedding particles, beaker method, absorbable stents, durability testing, acute testing, pH range, AAMI TIR42:2010, coating durability testers, coated stent, pulsatile flow
Particulate Capture from Vascular Stents
Keywords:
AAMI, vascular medical devices, particulates, source of particulates, particulate matter, Coating Durability Testers, chronic, acute, acute phase testing, stents, stent-grafts, catheters, balloons, capture filter, particles shed, chronic testing, coated stents, stent-grafts, tortuous pathway, SEM analysis
Radial Fatigue Testing of Vascular Stents: Single- vs. Double-Ended Pressurization
Keywords:
stents, stent-grafts, silicone mock vessels, radial fatigue testing, vascular device, frequency response, cyclic load, single-ended pressurization, double-ended pressurization, pressure pulses, stent deflection
SEM Analysis of Particles
Keywords:
ISO, AAMI, particulates shed, vascular devices, scanning electron microscope, SEM analysis, particles captured, particle counters, stents, catheter, fluid particles, filter membrane, chemical analysis, EDX, FTIR
Stent Radial Fatigue Testers: Now users have a choice.
Keywords:
stent radial fatigue tester, vascular prosthesis tester, renal, coronary, SFA, carotid, stents, mock vessels
Straight Mock Vessels Bent to Radius vs. Curved Mock Vessels
Keywords:
mock vessels, stents, stent grafts, radial fatigue testing, stents deployed, pulsatile pressure, mock vessel compliance, radial distension, pressure differential, coronary artery, curved mock vessels, stent deflection, laser micrometer, uniform distension
Test Sections for the M6 Heart Valve Tester
Keywords:
heart valve tester, test sections, heart valves, accelerated wear, durability testing, heart valve candidate, sewing the heart valve, mechanical, tissue, stentless, percutaneous heart valves, stentless, catheter delivered valves
Universal Controller for the M6
Keywords:
M6, heart valve tester, pressure transducers, systemic pressure, calibrated, TDMS, 21 CFR Part 11, regulatory agencies, encryption, verification of test parameters, user-defined alarms, accurate calibration, inflow, outflow, data analysis