Medzus | Prefilled Syringe Testing
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Bench Testing

Annex: C

C.1: Syringe Barrel Flange Breakage Resistance

C.2: Syringe Barrel Luer Cone Breakage Resistance

Annex: E

E.1: Syringe Plunger Gliding Force

Annex: F

F.1: Needle Penetration Test

F.2: Needle Stiffness Test (ISO 9626)

 

Annex: G: Closure System Tests

G.1: Needle Pull Force Test

G.2: Closure Cap Liquid Leakage

G.3: Luer Lock Adaptor Collar Pull Off Force

G.4: Luer Lock Adaptor Torque Resistance*

G.5: Luer Lock Rigid Tip Cap Unscrewing Torque*

G.6: Pull off force of the tip cap & Needle shield

Visual Inspection

Needle Cap Forces

Dose Accuracy Test

Air Transport Plunger Movement

CCIT Integrity Test

Priming Volume

Injection Forces

Leak Test Under Compression

Scope of Standards

ISO 11040 -1: Glass Cylinders For Dental Local Anaesthetic Cartridges Testing

ISO 11040 -2: Plunger Stoppers For Dental Local Anaesthetic Cartridges Testing

ISO 11040 -3: Seals For Dental Local Anaesthetic Cartridges Testing

ISO 11040 -4: Prefillable Syringes Testing

 

ISO 11040 -5: Plunger Stoppers For Injectables Testing

ISO 11040 -6: Plastic Barrels For Injectables Testing

ISO 11040 -7: Packaging Systems Testing

ISO 11040 -8: Finished Prefilled Syringes Testing