ISO 1135-4:2025

Overview

ISO 1135-4:2025 - Transfusion sets for single use, gravity feed specifies requirements for single‑use transfusion gravity sets used with blood and blood components. The standard ensures compatibility with blood containers and intravenous equipment and provides guidance on material quality, performance, component designations, sterility and labelling. It is intended to support safe blood transfusion practice while complementing any national pharmacopoeia or legally binding regulations.

Key topics and technical requirements

• Scope and purpose: Defines requirements to ensure compatibility of transfusion sets with a range of cellular and plasma blood components and IV equipment.
• Materials and biocompatibility: Components that contact blood must meet chemical and biological requirements (see Clauses 7 and 8). Biological risk assessment should follow ISO 10993-1.
• Physical performance (Clause 6 and Annex A):
  • Particulate contamination - manufacturing controls and smooth fluid-contacting surfaces; particle limits referenced by a contamination index.
  • Leakage - no air leakage when tested per Annex A.
  • Tensile strength - connections (excluding protective caps) must withstand a static tensile force of 15 N for 15 s.
  • Closure‑piercing device - dimensional guidance (reference 15 mm measurement), must pierce blood container closures without pre-piercing or coring, and resist a pull force of 15 N after insertion.
  • Additional components: tubing, filters for blood components, drip chamber, flow regulator, injection site, male conical fittings, protective caps.
• Chemical testing: Limits and test methods for metals, extractables, UV absorption, residue on evaporation (Clause 7 and Annex B).
• Biological requirements: Sterility requirements and device‑specific biological testing (Clause 8).
• Labelling and packaging (Clauses 9–10): Labelling aligned with ISO 15223‑1; packaging considerations reference ISO 11607‑1 for sterile barrier systems.
• Disposal (Clause 11): Guidance on end‑of‑life handling.

Practical applications - who uses ISO 1135-4:2025

• Medical device manufacturers designing and producing single‑use transfusion gravity sets to demonstrate safety, compatibility and regulatory readiness.
• Quality, regulatory and compliance teams assessing conformity with international standards.
• Blood banks and transfusion services specifying procurement requirements for transfusion sets compatible with blood bag systems.
• Hospitals and clinicians using standardized devices to reduce risk of leakage, contamination and incompatibility.
• Notified bodies and regulators referencing harmonized test methods and labelling expectations.

Related standards and references

• ISO 10993‑1, ISO 10993‑4, ISO 11607‑1, ISO 15223‑1, ISO 3826‑1, ISO 80369‑7, ISO 80369‑20, ISO 14644‑1, ISO 3696.

Keywords: ISO 1135-4:2025, transfusion sets, single use, gravity feed, blood transfusion, medical devices, sterility, biocompatibility, packaging, labelling, compatibility.