ISO 1135-5:2025

Overview

ISO 1135-5:2025 - Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus - defines requirements for single‑use transfusion sets intended to be used with pressure infusion equipment. The standard ensures mechanical and biological compatibility with containers for blood and blood components (red cells and plasma) and with intravenous equipment. It replaces ISO 1135-5:2015 and updates definitions, biological evaluation approaches, labelling and packaging references, and test descriptions for physical and chemical performance.

Key topics and technical requirements

• Scope and intent: Applies to single‑use transfusion sets designed to operate under pressure (pressure infusion apparatus) and to ensure safe delivery of blood and blood components.
• Designation and components: Standardizes component terminology (e.g., drip chamber, filter for blood, tubing, closure‑piercing device, injection site, male conical fitting, protective caps) to improve clarity and compatibility.
• Materials and performance: Specifies material quality requirements and directs that components in contact with blood must meet additional chemical and biological requirements.
• Physical requirements: Includes tests for particulate contamination, leakage, tensile strength, tubing characteristics, filters, drip chamber and drip tube, flow regulator and flow rates, injection sites, protective caps, and post‑occlusion bolus volume. Physical tests are detailed in Annex A.
• Chemical requirements: Addresses extractables and residues, metal ions, titration acidity/alkalinity and UV absorption testing; normative chemical test procedures are provided in Annex B.
• Biological requirements: Requires sterility and a biological risk assessment following ISO 10993‑1, with hemocompatibility considerations under ISO 10993‑4 and sample preparation per ISO 10993‑12.
• Labelling, packaging and disposal: Labelling is aligned with ISO 15223‑1 symbol requirements; packaging follows ISO 11607‑1 guidance for terminally sterilized devices. The standard includes requirements for unit and multi‑unit containers and disposal instructions.
• Annexes: Normative Annex A (physical tests), Annex B (chemical tests) and Annex C (determination of tube volumes).

Note: National pharmacopoeias or regulations may take precedence over the standard where legally binding.

Practical applications and users

• Medical device manufacturers designing single‑use transfusion sets for use with pressure infusion systems - to ensure product safety, compatibility and regulatory alignment.
• Regulatory bodies and notified bodies evaluating compliance for market approval and conformity assessment.
• Clinical procurement and hospital biomedical engineering teams selecting transfusion sets compatible with blood components and pressure infusion devices.
• Test laboratories performing physical, chemical and biological testing specified in the normative annexes.
• Standards writers and quality managers integrating ISO 1135‑5:2025 requirements into design controls, risk management and labelling.

Related standards (selected)

• ISO 1135-4 (gravity feed transfusion sets)
• ISO 10993‑1, ISO 10993‑4, ISO 10993‑12 (biological evaluation)
• ISO 15223‑1 (medical device symbols)
• ISO 11607‑1 (packaging for terminally sterilized devices)
• ISO 80369‑7 / ISO 80369‑20 (small‑bore connectors)

Keywords: ISO 1135-5:2025, transfusion sets, pressure infusion apparatus, single‑use, blood transfusion equipment, sterility, hemocompatibility, device labelling, packaging, ISO standards.