ISO 1135-4:2015

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

• ISO 3826-1 (blood containers), ISO 1135-3 / ISO 1135-5 (other transfusion/taking sets), ISO 594-1/2 (Luer fittings), ISO 10993 series (biocompatibility), ISO 15223-1 (symbols), ISO 14644-1 (cleanrooms).

Keywords: ISO 1135-4:2015, transfusion sets, gravity feed, single use, blood transfusion, medical device standards, compatibility, sterility, filter, closure‑piercing device, tubing.