EN ISO 1135-5:2025 PDF

Overview

EN ISO 1135-5:2025 - Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus - specifies requirements for single‑use transfusion sets designed to be used with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). The standard ensures mechanical, chemical and biological compatibility with containers for blood and blood components and with intravenous equipment. It also provides guidance on material quality, component designations and performance verification. Note: national pharmacopoeias or regulations may take legal precedence.

Key topics and technical requirements

This standard covers a comprehensive set of technical requirements and test methods, including:

• Scope and compatibility

  • Intended for single‑use transfusion sets used with pressure infusion apparatus.
  • Ensures compatibility with red cell and plasma blood components (platelets are explicitly excluded from pressure transfusion using these sets).

• Physical requirements

  • Particulate contamination limits, leakage, tensile strength and tubing integrity.
  • Closure‑piercing devices, filters for blood components, drip chamber and drip tube performance.
  • Flow regulator and flow‑rate characteristics, injection site requirements (including needle‑free and Luer‑activated devices), male conical fittings, protective caps and post‑occlusion bolus volume.

• Chemical requirements

  • Limits and tests for reducing (oxidizable) matter, metal ions, acidity/alkalinity, residue on evaporation and UV absorbance of extractables.

• Biological requirements

  • Sterility, pyrogenicity, haemolysis, general toxicity and assessments for depletion or damage to blood components.

• Labelling, packaging and disposal

  • Labelling requirements aligned with device identification standards and packaging guidance referencing ISO 11607‑1; disposal instructions for single‑use devices.

• Test annexes

  • Normative annexes specify physical, chemical and biological test methods and procedures, and methods to determine tube volumes.

Practical applications and users

Who uses EN ISO 1135-5:2025:

• Medical device manufacturers designing, validating and certifying single‑use transfusion sets and pressure infusion accessories.
• Quality, regulatory and compliance teams preparing CE marking documentation and conformity evidence.
• Hospital procurement, biomedical engineering and transfusion services evaluating product suitability for pressured blood administration.
• Test laboratories performing physical, chemical and biological testing of infusion devices.

Benefits:

• Ensures patient safety and blood‑component integrity during pressure transfusion.
• Provides harmonized tests and labelling expectations for regulatory compliance and market access in regions adopting EN/ISO standards.

Related standards

• ISO 10993‑1, ISO 10993‑4 (biological evaluation)
• ISO 11607‑1 (packaging for terminally sterilized devices)
• ISO 3826 series (plastic blood containers)
• ISO 3696 (water for analytical use)
• Relationship to Regulation (EU) 2017/745 is addressed in the standard’s informative annex (Annex ZA).