Mechanical Testing of Medical Devices

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 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

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

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

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

• 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

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.

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)

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

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

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 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.

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