Infusion System Testing

Administration Set Performance And Safety Testing

There are a variety of components used in parenteral administration. The test requirements for this equipment are 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 bottlesconnectors_e

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

Global Medical Device Testing, MET

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, Air Leakage, Water Leakage, Counter-flow Pressure Resistance, Volumetric Flow Rate, Blocking Performance - Counter-flow Closure Pressure of Check Valve, Opening pressure, Light Transparency, UV Absorption and Luer Gauging.

Chemical analysis usually includes: Redox Assessments, Metal Ion Testing and Solid Contamination Testing.

Biological tests cover: Sterility, Toxicity and Pyrogenicity.