ISO 5840-1:2015
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
ISO Link
Dynatek Labs’s testers that comply with this standard;
- Surgical valve durability
- Catheter delivered valve durability
- Membrane durability
- Septal defect closure durability
- Artificial heart bladder durability
- Film durability
- Heart valve performance testing
- Tests effective orifice area, perivalvular and paravalvular leakage
ISO 5840-2:2015
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
ISO Link
Dynatek Labs’s testers that comply with this standard;
- Surgical valve durability
- Catheter delivered valve durability
- Membrane durability
- Septal defect closure durability
- Artificial heart bladder durability
- Film durability
- Heart valve performance testing
- Tests effective orifice area, perivalvular and paravalvular leakage
ISO 5840-3:2013
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO Link
Dynatek Labs’s testers that comply with this standard;
- Catheter delivered valve durability
- Membrane durability
- Septal defect closure durability
- Artificial heart bladder durability
- Film durability
- Heart valve performance testing
- Tests effective orifice area, perivalvular and paravalvular leakage
ISO 7198:2016
Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
ISO Link
Dynatek Labs’s testers that comply with this standard;
- Dynamic internal compliance
- Testing of mock arteries and veins
- Dynamic internal compliance testing of candidate artery and vein replacements
- Radial durability testing of small vascular grafts
- Radial durability testing of small vascular stents
- Durability testing of vascular occlusion devices
- Radial durability testing of large diameter vascular grafts
- Radial durability testing of large diameter vascular stents
- Durability testing of large diameter vascular occlusion devices
- Larger and more robust version of SVP-24, but has the ability to switch out manifolds to test all sizes of devices
ISO 12417-1:2015
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
ISO Link
Dynatek Labs’s testers that comply with this standard;
- Radial durability testing of small stents containing drugs
- Durability testing of vascular occlusion devices containing drugs
- Radial durability testing of large diameter vascular grafts containing drugs
- Radial durability testing of large diameter drug coated stents
- Durability testing of large diameter vascular occlusion devices containing drugs
- Larger and more robust version of SVP-24, but has the ability to switch out manifolds to test all sizes of devices
CDT-5 Coating Durability Tester
- Five position vascular device containing drugs durability tester with in-line particle counter
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
CDT-20 Coating Durability Tester
- Twenty position drug containing device durability tester with in-line particle counters
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
- Replacement heart valve containing drugs durability
- Catheter delivered valve durability
- Membrane durability
- Septal defect closure durability
- Artificial heart bladder durability
- Film durability
ISO 14708-5:2010
Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
ISO Link
Dynatek Labs’s testers that comply with this standard;
- Pulsatile ventricular assist devices and all circulatory support devices
- Holds three samples and can be programmed to automatically switch between sleep, exercise, and normal settings
- Comprehensive data acquisition and control
- Necessary for destination therapy
ISO/TS 17137:2014
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
ISO Link
Dynatek Labs’s testers that comply with this standard;
- Radial durability testing of small absorbable vascular stents
- Durability testing of absorbable vascular occlusion devices
- Radial durability testing of large diameter absorbable vascular grafts
- Radial durability testing of large diameter absorbable stents
- Durability testing of large diameter vascular occlusion devices
- Larger and more robust version of SVP-24, but has the ability to switch out manifolds to test all sizes of devices
CDT-5 Coating Durability Tester
- Five position absorbable vascular device durability tester with in-line particle counter
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
CDT-20 Coating Durability Tester
- Twenty position absorbable device durability tester with in-line particle counters
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
ISO 25539-1:2017
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
ISO Link
Dynatek Labs’s testers that comply with this standard;
- Radial durability testing of small vascular grafts
- Radial durability testing of small vascular stents
- Durability testing of vascular occlusion devices
- Radial durability testing of large diameter vascular grafts
- Radial durability testing of large diameter vascular stents
- Durability testing of large diameter vascular occlusion devices
- Larger and more robust version of SVP-24, but has the ability to switch out manifolds to test all sizes of devices
ISO 25539-2:2012
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
ISO Link
Dynatek Labs’s testers that comply with this standard;
- Radial durability testing of small vascular stents
- Durability testing of vascular occlusion devices
- Radial durability testing of large diameter vascular stents
- Durability testing of large diameter vascular occlusion devices
- Larger and more robust version of SVP-24, but has the ability to switch out manifolds to test all sizes of devices
CDT-5 Coating Durability Tester
- Five position drug eluting vascular device durability tester with in-line particle counter
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
CDT-20 Coating Durability Tester
- Twenty position drug eluting vascular device durability tester with in-line particle counters
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
AAMI TIR42
AAMI TIR42/Ed.1, Evaluation of particulates associated with vascular medical devices
AAMI TIR42 Link
Dynatek Labs’s testers that comply with this standard;
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
ASTM F2394-07 (2017)
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
ASTM F2394-07 Link
Dynatek Labs’s testers that comply with this standard;
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
ASTM F2477-07
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
ASTM Link
Dynatek Labs’s testers that comply with this standard;
- Radial durability testing of small vascular grafts
- Radial durability testing of small vascular stents
- Durability testing of vascular occlusion devices
- Radial durability testing of large diameter vascular grafts
- Radial durability testing of large diameter vascular stents
- Durability testing of large diameter vascular occlusion devices
- Larger and more robust version of SVP-24, but has the ability to switch out manifolds to test all sizes of devices
CDT-5 Coating Durability Tester
- Five position vascular device durability tester with in-line particle counter
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
CDT-20 Coating Durability Tester
- Twenty position vascular device durability tester with in-line particle counters
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
ASTM F2743-11
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
ASTM Link
Dynatek Labs’s testers that comply with this standard;
CDT-5 Coating Durability Tester
- Five position drug eluting vascular device durability tester with in-line particle counter
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
CDT-20 Coating Durability Tester
- Twenty position drug eluting vascular device durability tester with in-line particle counters
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
ASTM F3036-13
Standard Guide for Testing Absorbable Stents
ASTM Link
Dynatek Labs’s testers that comply with this standard;
- Radial durability testing of small absorbable vascular grafts
- Radial durability testing of small absorbable vascular stents
- Durability testing of vascular occlusion devices
- Radial durability testing of large diameter absorbable vascular grafts
- Radial durability testing of large diameter absorbable vascular stents
- Durability testing of large diameter vascular occlusion devices
- Larger and more robust version of SVP-24, but has the ability to switch out manifolds to test all sizes of devices
CDT-5 Coating Durability Tester
- Five position vascular device durability tester with in-line particle counter
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
CDT-20 Coating Durability Tester
- Twenty position vascular device durability tester with in-line particle counters
- Superior to any bucket method tester
- Recoveries of greater than 90% when using standard particles
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- Manufacturing support for lot approval
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
ASTM WK46148
New Guide for Coating Characterization of Drug-Coated Balloons
ASTM Link
Dynatek Labs’s testers that comply with this standard;
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- Manufacturing support for lot approval
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
ASTM WK60510
New Test Method for Simulated use testing of neurointerventional device in tortuous vasculature
ASTM Link
Dynatek Labs’s testers that comply with this standard;
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- Manufacturing support for lot approval
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
ASTM WK60511
New Test Method for Particle evaluation and characterization for neurointerventional devices
ASTM Link
Dynatek Labs’s testers that comply with this standard;
- Evaluate size and number of particles shed during deployment of vascular devices including:
- Guide wires
- Delivery catheters
- Stents
- Drug coated stents
- Drug coated balloons
- Manufacturing support for lot approval
- The system is integral to the in-line particle counter which is a preferred technique to a bucket method. The APT repeatedly shows recoveries of greater than 90% with all sizes of particulate standards
Dynatek Labs, Inc.
105 East 4th Street
Galena, MO 65656
417.357.6155
800.325.8252
fax 417.357.6327
