Tests Performed

PhysioTest provides testing services for Active Implantable, Intravenous devices and surgical products. In addition, we provide testing services for most other medical devices and products including those without test standards in place.

Active Implantable Device Testing

Preconditioning

  • Thermal cycling
  • Accelerated Aging

Applicable Standards

  • EN 45502 series
  • ISO 14708-1 & -3: General & Neurostimulator
  • IEC 60601: Medical electrical equipment
  • ASTM F 1980 – 07: accelerated aging
  • ISO & ASTM packaging standards
  • IS-1 & IS4 cardiac lead connector standards
  • FDA guidelines

Durability

  • Lead Composite Torque Test
  • 10 yr longevity cycling
  • Lead Body Flex Test
  • Lead Body Composite Distal Fatigue
  • Connector Flex
  • Lead Composite Pull Test
  • Fixation Retention Force Test
  • Header to can strength
  • Seal integrity
  • X-ray identification

Implant Environment

  • Abrasion Test-Lead to Lead
  • Abrasion Test-Lead to Can
  • Clavicle-First Rib Compression Test
  • Abrasion Test-Lead to Valve
  • Corrosion

Implant Tool Interface

  • Stylet Insertion/Withdrawal Force Test
  • Catheter Insertion/ Withdrawal Force Test
  • Lead/Catheter Compatibility

Anchoring

  • Anchor Sleeve Suture Test

MRI Compatibility

Intravenous Device Testing

Preconditioning

  • Thermal cycling
  • Accelerated Aging
  • Shelf life

Durability

  • Catheter bond strength
  • Kink resistance
  • Twist integrity
  • Wire bond strength-proximal and distal
  • Catheter body fluid ingress test (gas pressure)
  • 3 point body deflection
  • Catheter integrity: tensile force
  • Catheter integrity: torque at each unique section
  • Catheter integrity: torque for working length of catheter
  • Tip stiffness
  • Side force
  • Corrosion

Steerability

  • Actuator hold force
  • Actuator slide force
  • Steerability: spring back
  • Steerability: linearity

Dimensional

  • Shaft diameter
  • Catheter length
  • Tip electrode dimension
  • Distal tip radius
  • Electrode spacing

Distal End Characteristics

  • Catheter reach
  • Steering deflection
  • Temperature sensor accuracy
  • Temperature sensor operating range

Electrical Characteristics

  • Catheter impedance
  • Ablation energy transfer
  • DC isolation resistance
  • RF isolation impedance
  • DC lead resistance
  • RF lead impedance
  • RF leakage current

MRI Compatibility