EN ISO 1135-4:2025 PDF

Overview - EN ISO 1135-4:2025 (Transfusion sets, single use, gravity feed)

EN ISO 1135-4:2025 specifies requirements for single‑use transfusion gravity sets used in medical transfusion of blood and blood components. Its primary aim is to ensure compatibility of transfusion sets with blood containers and intravenous equipment and to provide guidance on the quality and performance of materials. The standard covers designations for transfusion set components and compatibility with a range of cellular and plasma blood components. Note: national pharmacopoeias or regulations may take legal precedence in some countries.

Key topics and technical requirements

• Compatibility and designation
  • Requirements to ensure transfusion sets mate properly with blood containers and IV devices.
  • Standardized terminology and component designations for consistency across suppliers and users.
• Materials and performance
  • Guidance on selection and performance of materials used in tubing, drip chambers, filters and connectors to minimise blood component damage and contamination.
• Physical requirements and tests
  • Tests for particulate contamination, leakage, tensile strength, tubing integrity, filters, drip chamber performance, flow regulation and flow rates for blood components.
• Chemical and biological safety
  • Chemical limits (residue, extractables) and biological evaluation including sterility, pyrogenicity, haemolysis and toxicity in line with risk management.
• Connectors and injection sites
  • Considerations for needle‑free injection ports, Luer‑activated devices and small‑bore connector compatibility.
• Labelling, packaging and disposal
  • Labelling requirements aligned with ISO 15223‑1, packaging references (e.g., ISO 11607‑1) and guidance on single‑use disposal to prevent reuse and contamination.
• Normative test methods
  • Annexes specify physical, chemical and biological test procedures for conformity verification.

Applications and who uses this standard

• Medical device manufacturers designing and producing single‑use transfusion sets and components.
• Quality, regulatory and compliance teams validating device safety, materials and labelling.
• Blood banks, hospitals and clinical procurement for product selection and specification.
• Test laboratories conducting physical, chemical and biological performance testing.
• Notified bodies and regulators assessing conformity with medical device safety and performance requirements.

Related standards (selected)

• ISO 10993‑1 (biological evaluation)
• ISO 10993‑4 (blood interactions)
• ISO 11607‑1 (sterile packaging)
• ISO 15223‑1 (medical device symbols)
• ISO 80369‑7 / ISO 80369‑20 (small‑bore connectors)

EN ISO 1135-4:2025 is essential for ensuring safe, compatible and high‑quality gravity feed transfusion sets used across clinical transfusion practice.