MEDICAL DEVICE TESTING

Materials Characterization

  • Microstructure
    Exam on cross-section by metallurgical microscope in order to determine:

1. Structure type
2. Grain size
3. Presence of phases (i.e. delta ferrite )
4. Inclusion content
5. Cast analysis

  • Hardness Measurement

Rockwell HRB/HRC

  • Corrosion

Determine the susceptibility to intergranular attack in austenitic stainless steels in medium containing:
- Nitric acid
- Sulphuric acid


Mechanical Testing

ENGINEERING GOODS & MEDICAL IMPLANTS
Our Lab is equipped with high precision equipment to meet the testing requirements for: 

  • Tensile Testing
  • Static and Dynamic Bending
  • Metal Fatigue Testing
  • Torsion and Pull Out Testing
    These all testing requirements are met for every customized testing requirements as per applicable requirements like IS, ISO, ASTM and BSI 

Transport Safety Studies

Distribution Simulation Testing

  • Drop Test
  • Vibration Test
  • Compression Test

Testing and Validation of Packaging for Medical Devices

Testing and validation is done in compliance to ISO 11607-1, ISO 11607-2 and designed to meet the compliance with FDA, ISO, EN and CE mark requirements.

Package Validation Testing is vital to ensure package integrity

  • Medical Device Packaging is highly regulated and must meet Regulatory requirement
  • Packaging testing is measuring the characteristics and property of packing material
  • Most precarious factor is the sterility which should be maintained throughout the distribution and storage
  • Testing a new packaging design before full scale manufacturing can save time and money.

Reference Standards for Packaging Validation

  • ASTM D 4169
  • ASTM D 7386
  • ASTM D642
  • ASTM D880
  • ASTM D951
  • ASTM D996
  • ASTM D4332
  • ASTM D4728
  • ASTM D5265
  • ASTM D5276
  • ASTM D5487
  • ASTM D6344
  • ASTM D7386
  • ASTM F1327

Package Integrity Testing

  • Seal Integrity
    • Visual Inspection
    • Dye penetration
  • Seal Strength
  • Peel Test
  • Burst test
  • Bubble Test

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