Infusion Set Testing
Infusion sets must deliver fluids accurately and safely while maintaining secure connections throughout clinical use. These devices are critical components of intravenous therapy systems, where flow accuracy, leakage prevention, and connection integrity are essential to patient safety.
Testing programmes for infusion sets evaluate flow performance, leakage resistance, and connector compatibility. Alignment with ISO 8536 and ISO 80369 supports the generation of robust, regulator-ready data for global regulatory submissions.
Why testing is critical for Infusion Sets
Infusion sets operate in controlled clinical environments but must perform consistently under varying pressures and handling conditions. Inaccurate flow delivery or connection failure can directly impact treatment effectiveness and patient safety.
Key challenges include:
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- Ensuring accurate and consistent flow rates
- Preventing leakage under pressure
- Demonstrating secure and compatible connections
- Managing risks of misconnections
- Supporting packaging integrity and distribution robustness
- Meeting global regulatory expectations for infusion systems
Comprehensive testing helps identify risks early and provides the evidence required for regulatory approval.
Infusion Set testing services across the device lifecycle
Analytical Chemistry
Material characterisation and extractables and leachables studies support product safety.
Microbiology & Sterility
Bioburden and sterility testing support microbiological safety for sterile infusion products.
Physical & Packaging Testing
Flow rate evaluation, leakage testing, connection integrity testing, and packaging validation support device reliability.
Biocompatibility & Toxicology
ISO 10993 biological evaluation supports safe patient contact.
Consultancy & Scientific Support
Testing strategies and submission support help navigate global regulatory pathways.
Supporting every stage of the Infusion Set lifecycle
Infusion Set standards and regulatory expectations
Testing programmes for infusion sets are typically aligned with:
- ISO 8536 for infusion equipment
- ISO 80369 for small-bore connectors and misconnection prevention
Alignment with recognised standards helps ensure robust, regulator-ready data for global submissions.
Partner with Cormica
Integrated testing programmes bring together expertise across microbiology, analytical chemistry, physical testing, and biocompatibility to support infusion system development from concept through to commercialisation. Decades of experience across hundreds of device programmes worldwide help teams generate reliable data and move forward with confidence.
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
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