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Testing of Infusion Equipment for Medical Use

Infusion EquipmentInfusion EquipmentInfusion EquipmentInfusion EquipmentInfusion EquipmentInfusion EquipmentInfusion EquipmentInfusion EquipmentThere are a variety of components used in parenteral administration. The test requirements for this equipment is detailed in ISO 8536 Infusion equipment for medical use, which is closely related to ISO 8871 Elastomeric parts for parenterals and for devices for pharmaceutical use.

Comprehensive testing to both of these standards and for luer connectors (ISO 594) is available from MET:

  • ISO 8536-1 Infusion equipment for medical use -- Part 1: Infusion glass bottles
  • ISO 8536-2 Infusion equipment for medical use -- Part 2: Closures for infusion bottles
  • ISO 8536-3 Infusion equipment for medical use -- Part 3: Aluminium caps for infusion bottles
  • ISO 8536-4 Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
  • ISO 8536-5 Infusion equipment for medical use -- Part 5: Burette infusion sets for single use, gravity feed
  • ISO 8536-6 Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles
  • ISO 8536-7 Infusion equipment for medical use -- Part 7: Caps made of aluminium-plastics combinations for infusion bottles
  • ISO 8536-8 Infusion equipment for medical use -- Part 8: Infusion equipment for use with pressure infusion apparatus
  • ISO 8536-9 Infusion equipment for medical use -- Part 9: Fluid lines for use with pressure infusion equipment
  • ISO 8536-10 Infusion equipment for medical use -- Part 10: Accessories for fluid lines for use with pressure infusion equipment
  • ISO 8536-11 Infusion equipment for medical use -- Part 11: Infusion filters for use with pressure infusion equipment
  • ISO 8536-12 Infusion equipment for medical use -- Part 12: Check valves

Testing regimes include: physical requirements; Chemical requirements and Biological requirements.

Physical tests typically include; Particulate Contamination, Tensile Strength, Leakage Air, Leakage Water, Counter-flow pressure resistance, Volumetric Flow Rate, Blocking performance - counter-flow closure pressure of check valve, Opening pressure, Transparency light, UV absorption, Luer gauging.

Chemical analysis usually includes: redox assessments, metal ion testing and solid contamination.

Biological tests cover: sterility, toxicity and pyrogenicity.