Overview - ISO 1135-4:2015 (Transfusion sets for single use, gravity feed)
ISO 1135-4:2015 is the international standard that specifies requirements for single-use transfusion gravity sets used in blood transfusion and administration of blood components. The standard ensures compatibility with blood/blood-component containers and intravenous equipment, and sets performance, material, chemical and biological safety criteria to minimize risks such as contamination, haemolysis or leakage. Note: national pharmacopoeia or regulations may legally supersede ISO requirements in some countries.
Key topics and technical requirements
- Scope & nomenclature: Defines component names (drip chamber, closure‑piercing device, filter, tubing, flow regulator, injection site, male conical fitting) and recommended arrangements.
- Sterility & protective caps: Sets requirements to maintain sterility of internal fluid pathways until use.
- Materials & cleanliness: Materials contacting blood must meet physical, chemical and biological clauses; manufacturing must minimise particulate contamination and ensure smooth fluid pathways.
- Physical performance
- Filter: Filter for blood components with uniform pores and a minimum total area of 10 cm²; retained solid mass ≥ 80% of that retained on a reference filter (per test methods).
- Tubing: Transparent or translucent; minimum length from distal end to drip chamber ≥ 1 500 mm (including optional injection site and male conical fitting).
- Tensile strength: Component connections (excluding protective caps) must withstand a static tensile force of 15 N for 15 s.
- Closure‑piercing device: Must pierce blood bag ports without pre‑piercing or coring and resist a pull force of 15 N for 15 s when used with containers conforming to ISO 3826‑1:2013.
- Leakage & particulate tests: Sets must show no air leakage and meet particulate contamination index limits (see Annex A).
- Chemical tests: Limits and test methods for reducing (oxidizable) matter, metal ions, acidity/alkalinity, residue on evaporation and UV absorption (Annex B).
- Biological tests: Requirements and test methods for sterility, pyrogenicity, haemolysis, toxicity, and assessment of blood component depletion/damage (Annex C).
- Labelling, packaging, disposal: Information, symbols and packaging to preserve sterility and support safe use and disposal.
Applications - who uses ISO 1135-4:2015
- Medical device manufacturers designing and producing single‑use transfusion sets (gravity feed).
- Quality assurance and regulatory teams for device compliance and premarket submissions.
- Clinical engineering, hospital procurement and blood banks selecting transfusion equipment compatible with blood bag systems.
- Test laboratories performing physical, chemical and biological conformity testing.
- Designers ensuring device compatibility with standards such as ISO 3826-1, ISO 594 (Luer fittings) and ISO 10993 biological evaluation.
Related standards
Keywords: ISO 1135-4:2015, transfusion sets, gravity feed, single use, blood transfusion, medical device standards, compatibility, sterility, filter, closure‑piercing device, tubing.