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Administration Set Performance And Safety Testing

There are a variety of components used in parenteral administration (infusion systems). 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 as well as for luer connectors (ISO 80369) is available from MET. These include:

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, 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.