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Mechanical Testing of Medical Devices

Do your medical devices comply with international standards and norms? Do your implants meet all requirements? We are your reliable partner for the testing and assessment of your medical devices.

Preclinical and mechanical testing of your medical devices is of utmost importance and ensures safety and confidence for your customers. Our laboratories look back on decades of experience in the industry of research, development and testing of medical devices, and can provide you with individual solutions and test methods to prove the safety of your product.

Our laboratories are equipped with state-of-the-art technology to support you in the best possible way!

Do you need assistance?

Please do not hesitate to contact our service team.
We will be happy to advise you via live chat or by e-mail at hello@tentamus.com or by phone at +1 303 456 4665

1. Mechanical Stent & Stent Graft Testing

 

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.

 

The following tests are performed by Tentamus Group laboratories according to 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.

2. Vascular Graft Testing

 

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. This 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

3. 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

4. Heart Valve Testing

 

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)

5. 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 including: peripheral, neurological, coronary and radial access routes within our established testing apparatus.

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

As experts in validating and performing these test methods, you as a manufacturer can engage Tentamus Laboratories to ensure that complex studies are performed correctly and in accordance with ASTM F2743:

  • Basic Particle Evaluation
  • Pre-test coating inspection
  • Inspection of the coating after the test
  • Particle evaluation after simulated application

6. MRI Compatibility and 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

What does the Tentamus service for medical device manufacturers include?

 

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.

In addition, 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.

  • Additionally, our laboratory BDC Laboratories in the USA manufactures silicone sample vessels in many configurations. Learn more here: Mock Vessel Models
  • Biocompatibility testing of medical devices according to ISO 10993 can also be covered by Tentamus Group’s global laboratory network, thus ensuring patient safety.Learn more here: Medical Device Biocompatibility 

Overview of analytical laboratories for mechanical testing of medical devices of the Tentamus Group

 

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

Do you need assistance? Please feel free to contact us here: hello@tentamus.com

Tentamus laboratories in your vicinity