Medical Device Testing Standards

ISO 5840-1:2015

Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
ISO Link

Dynatek Labs’s testers that comply with this standard;

M6 Heart Valve Tester

 

  • Surgical valve durability
  • Catheter delivered valve durability
  • Membrane durability
  • Septal defect closure durability
  • Artificial heart bladder durability
  • Film durability

MP3 Pulse Duplicator

 

  • 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;

M6 Heart Valve Tester

 

  • Surgical valve durability
  • Catheter delivered valve durability
  • Membrane durability
  • Septal defect closure durability
  • Artificial heart bladder durability
  • Film durability

MP3 Pulse Duplicator

 

  • 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;

M6 Heart Valve Tester

 

  • Catheter delivered valve durability
  • Membrane durability
  • Septal defect closure durability
  • Artificial heart bladder durability
  • Film durability

MP3 Pulse Duplicator

 

  • 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;

DCT Compliance Tester

 

  • Dynamic internal compliance
  • Testing of mock arteries and veins
  • Dynamic internal compliance testing of candidate artery and vein replacements

SVP-24 Stent Tester

 

  • Radial durability testing of small vascular grafts
  • Radial durability testing of small vascular stents
  • Durability testing of vascular occlusion devices

UST Stent Tester

 

  • 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;

SVP-24 Stent Tester

 

  • Radial durability testing of small stents containing drugs
  • Durability testing of vascular occlusion devices containing drugs

UST Stent Tester

 

  • 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

Acute Particulate Tester

 

  • 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

M6 Heart Valve Tester

 

  • 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;

PVAD Pulsatile VAD Tester

 

  • 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;

SVP-24 Stent Tester

 

  • Radial durability testing of small absorbable vascular stents
  • Durability testing of absorbable vascular occlusion devices

UST Stent Tester

 

  • 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

Acute Particulate Tester

 

  • 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;

SVP-24 Stent Tester

 

  • Radial durability testing of small vascular grafts
  • Radial durability testing of small vascular stents
  • Durability testing of vascular occlusion devices

UST Stent Tester

 

  • 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;

SVP-24 Stent Tester

 

  • Radial durability testing of small vascular stents
  • Durability testing of vascular occlusion devices
UST Stent Tester

  • 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

Acute Particulate Tester

 

  • 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;

Acute Particulate Tester

 

  • 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;

Acute Particulate Tester

 

  • 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;

SVP-24 Stent Tester

 

  • Radial durability testing of small vascular grafts
  • Radial durability testing of small vascular stents
  • Durability testing of vascular occlusion devices

UST Stent Tester

 

  • 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

Acute Particulate Tester

 

  • 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;

SVP-24 Stent Tester

 

  • Radial durability testing of small absorbable vascular grafts
  • Radial durability testing of small absorbable vascular stents
  • Durability testing of vascular occlusion devices

UST Stent Tester

 

  • 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

Acute Particulate Tester

 

  • 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;

Acute Particulate Tester

 

  • 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;

Acute Particulate Tester

 

  • 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;

Acute Particulate Tester

 

  • 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