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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