Knowledge Base

Medical Device Testing

ISO ASTM

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

Stent testing, medical device testing, Dynatek Labs

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

Stent deployment

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)

M6 Heart Valve Tester

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 Stents and Catheters

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 stent testing

Custom Capabilities

Keywords:

custom solutions, startups, SolidWorks, heart valve, testing capacity, test equipment, Dynatek Labs, stent, heart valve, cardiovascular (CV) device

M6 Heart Valve Tester

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 and Catheters

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:

  1. Real-time Particulate Matter Evaluation during Deployment and Withdrawal
  2. Coating Integrity Inspection

M6 Heart Valve Tester

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 pressurization

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

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

Test section for heart valve testing

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

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 filter

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 

Double-Ended Pressurization

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

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

SVP Stent Tester

Stent Radial Fatigue Testers: Now users have a choice.

Keywords:

stent radial fatigue tester, vascular prosthesis tester, renal, coronary, SFA, carotid, stents, mock vessels

Stent Testing

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

SEM Analysis of Particles

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

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

Dynatek Labs, Inc.
105 East 4th Street
Galena, MO 65656
417.357.6155
800.325.8252
fax 417.357.6327