ISO 15675:2016

Overview

ISO 15675:2016 defines safety, performance and testing requirements for sterile, single‑use arterial blood line filters used in cardiopulmonary bypass (CPB) systems. The standard covers design and manufacturing expectations for filters that remove emboli, debris, blood clots and gaseous material from arterial blood during CPB. It sets biological, physical and performance criteria and describes the tests and documentation manufacturers must provide to demonstrate compliance.

Key Topics

• Scope and purpose: Requirements specific to arterial blood line filters as part of CPB systems and their intended clinical use.
• Biological characteristics: Filters and blood pathways must be sterile and non‑pyrogenic; finished devices require biocompatibility verification.
• Physical characteristics:
  • Blood pathway integrity: Pressure/leak testing (1.5× manufacturer’s rated pressure or 152 kPa gauge if unspecified, maintained for 6 hours or the intended use time).
  • Blood volume: Manufacturer-specified tolerances for blood pathway volume.
  • Connectors: Secure connections and conformity with connector standards (e.g., ISO 594‑2). Typical acceptable tube sizes noted include 4.8, 6.3, 9.5 and 12.7 mm.
• Performance characteristics:
  • Filtration efficiency: ≥ 80% removal of particles when tested with particles 20% larger than nominal pore size.
  • Blood cell damage: Measurement of plasma‑free hemoglobin, platelet and white blood cell changes; values must be within manufacturer‑specified ranges.
  • Flow rate capacity, shelf life, and air‑handling capability: Demonstrated by test data per manufacturer specifications.
• Tests and measurements: Reference procedures include terminal sterilization, biocompatibility testing and functional tests at 37 °C ±1 °C. Alternative validated methods may be accepted.
• Information and packaging: Manufacturer must supply device, packaging and labeling information (e.g., instructions for use, shelf life, sterility and connector details).

Applications and Who Uses It

• Medical device manufacturers designing and validating arterial blood line filters for CPB.
• Quality assurance and regulatory teams preparing technical files, CE or other submissions.
• Test laboratories performing sterility, biocompatibility and performance verification.
• Clinical engineering and perfusion services evaluating device suitability and procurement decisions.
• Hospitals and procurement officers requiring evidence of compliance for purchasing.

Related Standards (applicable normative references)

Standards commonly referenced alongside ISO 15675:2016 include:

• ISO 594‑2 (Luer lock fittings)
• ISO 10993‑1, ‑7, ‑11 (biological evaluation)
• ISO 11135, ISO 11137‑1, ISO 14937, ISO 17665‑1 (sterilization processes)
• ISO 11607‑1, ISO 11607‑2 (packaging for terminally sterilized devices)

Keywords: ISO 15675:2016, arterial blood line filters, cardiopulmonary bypass systems, filtration efficiency, blood cell damage, biocompatibility, sterility, connector standards, CPB filter testing.