ISO 10555-8:2024

Overview

ISO 10555-8:2024 - Intravascular catheters - Sterile and single-use catheters - Part 8: Catheters for extracorporeal blood treatment (EBT) specifies general requirements for sterile, single-use intravascular catheters intended for extracorporeal blood treatments such as hemodialysis, hemofiltration, apheresis and therapeutic plasma exchange. The standard defines required performance testing, labelling and manufacturer information to ensure safe, predictable catheter function during extracorporeal blood treatment.

Key topics and technical requirements

• Scope and conformity: Catheters for EBT shall also conform to ISO 10555-1 (general requirements) and where applicable ISO 10555-3 and ISO 10555-5.
• Blood flowrate – pressure testing (Annex A, normative): Manufacturers must determine flowrate vs. pressure curves for arterial and venous lumens using a constant-flow source and clinically relevant test fluids at (37 ± 2) °C. Test fluids can be anticoagulated whole blood or plasma, or simulated blood (dynamic viscosity 3.2–3.8 mPa·s).
• Recirculation rate (Annex B, informative): For multi‑lumen catheters, percent recirculated blood from venous to arterial openings (and reverse unless contraindicated) must be measured using an anatomical blood-loop model and analytical markers.
• Mechanical haemolysis testing: Dynamic in vitro haemolysis testing in a recirculating blood loop that mimics worst‑case clinical pressures/flows is required. Results should report plasma free hemoglobin over time; paired testing with a predicate device and reference to standardized methods (e.g., ASTM F1841) is recommended.
• Colour coding: Lumen hubs/clamps must indicate flow direction - red for arterial, blue for venous.
• Manufacturer information: Required to supply flowrate vs. pressure charts (pressures in mmHg clinically sufficient), priming volumes for lumens, and recirculation percentages for multi-lumen designs.

Practical applications

• Provides a clear test and documentation framework for evaluating EBT catheters’ hydraulic performance, blood compatibility (haemolysis), and functional behaviour (recirculation).
• Ensures clinicians and dialysis units can compare catheter performance using standardized flow/pressure charts and recirculation data.
• Supports regulatory submissions, conformity assessments and quality assurance for medical device manufacturers.

Who uses this standard

• Catheter and medical device manufacturers (design, testing, technical files)
• Independent test laboratories and bench testing facilities
• Regulatory bodies and notified bodies assessing conformity
• Clinical engineers, procurement specialists and dialysis centers evaluating device suitability

Related standards

• ISO 10555-1, ISO 10555-3, ISO 10555-5 (series on sterile single-use intravascular catheters)
• ASTM F1841 (referenced for haemolysis testing methodology)

Keywords: ISO 10555-8, intravascular catheters, extracorporeal blood treatment, EBT catheters, blood flowrate testing, recirculation rate, mechanical haemolysis, sterile single-use catheters.