Features

Comprehensive Testing has been performed

• Biocompatibility testing ISO10993
  • Cytotoxicity
    
    
  • Skin Sensitization
    
    
  • Irritation
    
    
  • Acute Systemic Toxicity
    
    
  • Pyrogen
    
    
  • Hemolysis (Direct and Indirect)
    
    
  • Extractable FT-IR
    
    
  • Leachable heavy metals
    ​​​​​​​
    
  • Endotoxin USP<85>

• Gamma Sterilization Validation ISO 11137
  • 10-6 Sterility

• Shelf Life Testing as per ASTM 1980-16
  • 60 months

• Leak Testing
  • Inline 1000 mbar @180 seconds
    
    
  • Water and pressure test 1 hour

• Injection Site
  • Tested per ISO 15747

• Spike Port Adapter
  • Tested per ISO 15747

• TSE/BSE
  • TSE/BSE-Free
    ​​​​​​​
    
  • Melamine-Free

• Oxygen Transmissions
  • 1100/cc/m2 x 24 hours

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