ISO 1135-5:2015

Overview - ISO 1135-5:2015 (Transfusion sets for pressure infusion apparatus)

ISO 1135-5:2015 is an international standard that specifies safety, design and performance requirements for single‑use transfusion sets intended for use with pressure infusion apparatus capable of generating pressures up to 200 kPa (2 bar). The standard ensures compatibility with containers for blood and blood components and with standard intravenous equipment, and provides guidance on materials, labelling, packaging and biological/chemical testing. Note: platelet components should not be transfused under pressure using these sets, and national pharmacopoeia or regulations may take precedence.

Key technical topics and requirements

• Pressure rating and compatibility: Designed for use with pressure infusion equipment up to 200 kPa (2 bar); compatibility with blood and blood component containers (red cells, plasma) is required.
• Sterility and contamination control: Sets must be supplied with protective caps and manufactured to minimise particulate contamination; internal fluid pathways must be smooth and clean.
• Physical performance: Includes mandatory tests for leakage (no air leakage), particulate contamination limits, and tensile strength (connections generally to withstand 15 N for 15 s).
• Closure‑piercing device: Defined dimensions and performance - must pierce blood bag closures without pre‑piercing or coring; surface treatment or material selection is recommended to facilitate insertion.
• Fluid pathway components: Requirements and designations for drip chamber, tubing, filters for blood and blood components, flow regulator, injection site, male conical fittings and protective caps.
• Chemical and biological safety: Guidance on extractables/ leachables, metal ion limits, acidity/alkalinity, sterility, pyrogenicity, haemolysis and cytotoxicity according to referenced biological evaluation standards.
• Storage and bolus volume: Annex D addresses storage volume and the concept of bolus volume when tubing is pressurised.
• Documentation: Labelling, unit and multi‑unit container marking, packaging and disposal instructions are specified.

Practical applications

• Design and manufacture of single‑use transfusion sets for pressure infusion systems.
• Product validation, quality control and compliance testing (physical, chemical, biological).
• Clinical procurement and risk assessment for hospitals, blood banks and emergency/operating room services using pressure infusion.
• Regulatory submissions and conformity assessment for medical device manufacturers.

Who should use ISO 1135-5:2015

• Medical device designers and manufacturers of transfusion and infusion equipment
• Quality and regulatory affairs professionals preparing technical files and compliance evidence
• Clinical engineers, hospital procurement teams and blood service colleagues evaluating device compatibility and safety

Related standards (examples)

• ISO 1135 (other parts: blood‑taking sets, gravity feed transfusion sets)
• ISO 10993 series (biological evaluation)
• ISO 594‑1/2 (Luer conical fittings)
• ISO 3826 (plastic blood containers)

Keywords: ISO 1135-5, transfusion sets, pressure infusion apparatus, single‑use, blood compatibility, sterility, closure‑piercing device, particulate contamination, medical device standard.