Testing of
Mechanical Stents & Stent Grafts

To ensure the safety and reli­a­bility of your stents, certi­fied mechan­ical testing of the mate­rial and finished product is essen­tial. Tentamus Group labo­ra­to­ries routinely perform mechan­ical testing of stents and stent grafts (cardio­vas­cular and endovas­cular) according to EN ISO 25539 – 1, ‑2 and 3 and ASTM standards.

We also develop test methods for new and unique tech­nolo­gies upon customer request, allowing us to provide indi­vid­u­al­ized support and advice.

Tests der Labore der Tentamus Group nach EN ISO 25539-1, -2 & 3

Implants:

  • Dimen­sional Verification
  • Diam­eter to Balloon Infla­tion Pressure
  • Length to Diam­eter Relationship
  • Recoil
  • Inte­gral Water Permeability
  • Water Entry Pressure
  • Fabric Water Permeability
  • Burst/​Circumferential Strength
  • Crush Resis­tance (Flat Plate & Radial)
  • Flex/​Kink
  • Local Compres­sion
  • Longi­tu­dinal Tensile Strength
  • Migra­tion Resistance
  • Modular Pull Strength
  • Magnetic Reso­nance Imaging (MRI) Safety
  • Radial Force
  • Strength After Repeated Puncture
  • Graft to Stent Attach­ment Strength
  • Corro­sion Assessment
  • Radial Dura­bility
  • Bending Dura­bility
  • Axial Dura­bility
  • Torsional Dura­bility
  • Dislodge­ment Force
  • Dogboning
  • Profile Effect/​Flaring
  • Stent-Free Surface Area

Endovas­cular System:

  • Dimen­sional Verification
  • Profile/​Diameter
  • Hemo­stasis
  • Simu­lated Use
  • Force to Deploy

Delivery System:

  • Balloon Infla­tion / Defla­tion Time
  • Balloon Rated Burst Pressure
  • Balloon Volume to Burst
  • Balloon Rated Fatigue
  • Tensile Bond Strength
  • Torsional Bond Strength
  • Tubing Longi­tu­dinal Tensile Strength

We test according to ASTM standards:

  • F2477: In vitro Pulsatile Dura­bility Testing of Vascular Stents
  • F2942: In vitro Axial, Bending, and Torsional Dura­bility Testing of Vascular Stents
  • F2743: Coating Inspec­tion and Acute Partic­u­late Char­ac­ter­i­za­tion of Coated Drug-Eluting Vascular Stent Systems
  • F2079: Measuring Intrinsic Elastic Recoil of Balloon-Expand­able Stents
  • F2081: Char­ac­ter­i­za­tion and Presen­ta­tion of the Dimen­sional Attrib­utes of Vascular Stents
  • F2394: Measuring Secure­ment of Balloon Expand­able Vascular Stent Mounted on Delivery System
  • F3067: Radial Loading of Balloon Expand­able and Self Expanding Vascular Stents
  • F2052: Measure­ment of Magnet­i­cally Induced Displace­ment Force on Medical Devices in the Magnetic Reso­nance Environment
  • F2119: Eval­u­a­tion of MR Image Arti­facts from Passive Implants
  • F2182: Measure­ment of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Reso­nance Imaging (MRI)
  • F2213: Measure­ment of Magnet­i­cally Induced Torque on Medical Devices in the Magnetic Reso­nance Environment
  • F2503: Marking Medical Devices and Other Items for Safety in the Magnetic Reso­nance Environment
  • F2129: Stan­dard Test Method for Conducting Cyclic Poten­tio­dy­namic Polar­iza­tion Measure­ments to Deter­mine the Corro­sion Suscep­ti­bility of Small Implant Devices
  • F3044: Test Method for Stan­dard Test Method for Eval­u­ating the Poten­tial for Galvanic Corro­sion for Medical Implants

Testing of
Vascular Grafts

Exten­sive knowl­edge, qual­i­fied staff and many years of expe­ri­ence allow us to offer a wide range of implant testing for vascular implants (so-called endo­grafts). These include:

  • Textile
  • Biolog­ical
  • ePTFE-
  • Polyurethane
  • and arte­rial-venous (A/V) access implants
Accord­ingly, the Tentamus Group labo­ra­to­ries can offer complete solu­tions according to DIN stan­dard EN ISO 7198 for your vascular pros­thesis technologies

his offers you, as the manu­fac­turer, the possi­bility to obtain all exam­i­na­tions from a single source:

  • Visual Inspec­tion
  • Inte­gral Water Perme­ability / Leakage
  • Longi­tu­dinal Tensile Strength
  • Usable Length
  • Wall Thick­ness
  • Dynamic Compli­ance
  • Porosity
  • Water Entry Pres­sure (WEP)
  • Burst Strength
  • Relaxed Inner Diameter
  • Suture Reten­tion Strength
  • Water Perme­ability
  • Circum­fer­en­tial Tensile Strength
  • Burst Strength after Repeated Puncture
  • Pres­sur­ized Inner Diameter
  • Kink Diam­eter / Radius

Testing of
Catheters

Within the Tentamus Group, mechan­ical testing of the following catheters and guidewires can also be performed:

  • CVC catheter (central venous catheter)
  • PICC catheter (periph­er­ally inserted central catheter)
  • PTCA catheter (percu­ta­neous trans­lu­minal coro­nary angioplasty)
  • Dial­ysis catheter
  • Guiding catheter
  • Intro­ducer catheter
All exam­i­na­tions and tests are performed in accor­dance with legal require­ments and stan­dards (ISO, FDA).
  • Catheter testing according to EN ISO 10555:

    • Surface Inspec­tion
    • Corro­sion Resistance
    • Peak Tensile Force
    • Liquid Leakage Under Pressure
    • Air Leakage During Aspiration
    • Deter­mi­na­tion of Catheter Flowrate
    • Burst Pres­sure
    • Power Injec­tion for Flowrate and Pressure
  • Catheter testing according to EN ISO 11070:

    • Surface Inspec­tion
    • Corro­sion Resistance
    • Strength of Union of Needle to Hub
    • Force At Break
    • Leakage From Sheath Introducer
    • Leakage Through Hemo­stasis Valve
    • Guidewire Frac­ture Test
    • Guidewire Flexing Test
    • Safety Wire to Coil Strength
    • Core Wire to Coil Strength
    • Strength of Union Hub to Dilator
  • Catheter Testing according to FDA Guide­line 824:

    • Dimen­sional Verification
    • Pres­sure vs. Flow Characterization
    • Catheter Body Tensile Strength
    • Catheter Stiff­ness
    • Body to Hub Tensile Strength
    • Tip Attach­ment Strength
    • Catheter Elon­ga­tion
    • Leakage At Hub
    • Catheter Burst Pressure
    • Catheter Flex­ural Fatigue

Testing of
Heart Valves

With in-depth knowl­edge of cardio­vas­cular fluid dynamics, heart valve testing require­ments, and the regu­la­tory envi­ron­ment, our team can be a unique resource for your hydro­dy­namic heart valve testing and dura­bility testing needs for surgical and tran­scatheter heart valves.

In addi­tion, as experts in endovas­cular stent testing, the Tentamus team can also meet the testing require­ments of tran­scatheter heart valve frames and structures.

The test proce­dures are performed according to the DIN EN ISO 5840 – 1, ‑2 & ‑3 series of standards:

  • Eval­u­a­tion of pulsatile hydrodynamics
  • Eval­u­a­tion of pres­sure drop and reflux leakage during steady forward flow
  • Accel­er­ated wear dura­bility (AWT)
  • Eval­u­a­tion of fatigue of compo­nents / struc­tures (stent frames and commissures)

Coating Integrity and Acute Particle Testing
of Medical Devices

Our under­standing of testing methods goes beyond simple testing prac­tices and allows us to vali­date the use of any simu­lated test model.

Our estab­lished testing appa­rati comprise periph­eral, neuro­log­ical, coro­nary and radial access routes.

Our labo­ra­to­ries are expe­ri­enced in regu­la­tory submis­sions for eval­u­a­tion of many tech­nolo­gies including:

  • Stents (ASTM 2743)
  • Tran­scatheter heart valves
  • endovas­cular delivery systems
  • Guidewires
  • Guiding catheters
  • PTCA catheters (FDA Guid­ance Document)
  • Vena cava filters

Als Experten für die Vali­dierung und Durch­führung dieser Prüfver­fahren können Sie als Hersteller die Tentamus Labore damit beauf­tragen, sicherzustellen, dass komplexe Studien korrekt und nach der Richtlinie ASTM F2743 durchge­führt werden:

  • Basis-Partikel­be­w­er­tung
  • Inspek­tion der Beschich­tung vor dem Test
  • Inspek­tion der Beschich­tung nach dem Test
  • Partikel­be­w­er­tung nach simulierter Anwendung

MRI Compatibility
& Safety Testing
of Medical Devices

Non-active medical devices in the MRI envi­ron­ment require magnetic field compat­i­bility testing. Accred­ited to ISO/IEC 17025:2005, Tentamus Group labo­ra­to­ries can perform MRI compat­i­bility testing. By offering both numer­ical modeling and phys­ical testing, our U.S. labo­ra­tory, BDC Labs, is not only able to support the global cardiac and endovas­cular commu­nity with this service, but also to provide MRI testing for ortho­pedic, spinal, and other passive implant types.

These tests are performed according to ASTM standards:

  • F2052: Stan­dard Test Method for Measure­ment of Magnet­i­cally Induced Displace­ment Force on Medical Devices in the Magnetic Reso­nance Environment
  • F2119: Stan­dard Test Method for Eval­u­a­tion of MR Image Arti­facts from Passive Implants
  • F2182: Stan­dard Test Method for Measure­ment of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Reso­nance Imaging
  • F2213: Stan­dard Test Method for Measure­ment of Magnet­i­cally Induced Torque on Medical Devices in the Magnetic Reso­nance Environment
  • F2503: Stan­dard Prac­tice for Marking Medical Devices and Other Items for Safety in the Magnetic Reso­nance Environment

According to FDA Guidance:

  • Estab­lishing Safety and Compat­i­bility of Passive Implants in the Magnetic Reso­nance (MR) Environment
  • Assess­ment of Radiofre­quency-Induced Heating in the Magnetic Reso­nance (MR) Envi­ron­ment for Multi-Config­u­ra­tion Passive Medical Devices

Service offers
for medical device manufacturers

Our mechan­ical testing services offer our customers a complete program for their medical device tech­nolo­gies, such as stents, catheters or heart valves: From research and devel­op­ment (R & D) support, func­tional product testing and eval­u­a­tion, to the devel­op­ment and certi­fi­ca­tion of new indi­vidual test methods.

Our labo­ra­to­ries can advise you as a manu­fac­turer regarding FMEA/​hazard analysis for your medical devices and develop appro­priate test/​inspection plans (according to ASTM or ISO test method stan­dards) to prevent product fail­ures and iden­tify the source of any damage.
  • Our labo­ra­tory BDC Labo­ra­to­ries in the USA manu­fac­tures sili­cone sample vessels in many configurations.
  • Biocom­pat­i­bility testing of medical devices according to ISO 10993 can also be covered by Tentamus Group’s global labo­ra­tory network, thus ensuring patient safety.

Overview of
laboratories for mechanical testing of medical devices

The following labo­ra­to­ries from the Tentamus Group offer mechan­ical testing services:

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