Testing of Medical

Devices
Syringes
Segments of Syringe
Dimension Tests
• Barrel Inner and Outer Diameter
• Size of Finger Flange
• Stopper and Plunger Dimensions
• Graduation Line Spacing
Instrumentation
• Vernier Caliper
• Micropipette
Syringe Integrity Testing
• Dye Penetration
• Blister Seal Strength
• Leakage
Instrumentation
• Microbiological Testing for Seal strength/Integrity
• Bubble Test
• Blue Bath Method
• High Voltage Leak Detection (HVLD)
• Laser Headspace Analysis
• Pressure and Vacuum Decay Method
• Dye Penetration Test Kit
Compatibility Checking
• Ease of Assembly
• Resistance to overriding
• Stress Cracking
• Separation force
• Unscrewing torque
• Coring Needle Test
• Anti-needle stick
• Tip cap removal force
Instrumentation
Instrumentation
• Electroplus E3000 Linear Torsion for resistance to overriding
• ASTM F2878 hypodermic needle test is employed to measure the
amount of force needed to puncture through the test material and is
used for Needle stick resistance test.
Performance Testing
• Glide Force
• Break-loose force
• Dead Space
• Dose Accuracy
• Injection Force
• Piston seal blowback
Instrumentation
• Zwickroell Apparatus for Glide and Break Loose Force
• Automatic and semi automatic inspection systems
Breakage Resistance
• Bite force
• Crush Test
• Drop Test
Instrumentation
• Zwickroell Apparatus of different kinds
Shelf Life Studies
• Real Time Aging
• Accelerated Aging
• The shelf life studies for Sterile Medical Devices can be done by ASTM
F 1980.