ISO 8637-3:2024

Overview

ISO 8637-3:2024 - Extracorporeal systems for blood purification - Part 3: Plasmafilters - specifies requirements and test methods for sterile, single‑use plasmafilters used to separate plasma from blood in therapeutic plasmapheresis. The standard covers device design, performance verification, labelling and packaging for human clinical use, and excludes extracorporeal blood circuits, dialysis/filtration devices, pumps, vascular access and whole-system plasma separation equipment.

Key topics and requirements

This edition defines mandatory topics and test methods (see Clauses 4–6 and 5 respectively). Major technical subjects include:

• Biological safety and haemocompatibility: Evaluation of materials and surfaces that contact blood in accordance with ISO 10993 series.
• Sterility and non‑pyrogenicity: Requirements and verification to ensure blood and filtrate pathways are sterile and non‑pyrogenic.
• Mechanical characteristics: Structural integrity, blood compartment integrity and connector dimensions designed to minimize blood leaks and air ingress.
• Performance characteristics: Measurement and reporting of:
  • Plasma filtration rate
  • Sieving coefficient (solute passage into filtrate)
  • Blood compartment volume
  • Blood compartment pressure drop
  • Haemolytic characteristics
• Transmembrane pressure (TMP): Defined method for calculating mean pressure across the membrane.
• Expiry date, labelling and documentation: Essential labelling on device and containers plus user information to reduce misuse (e.g., inadvertent use for haemofiltration).
• Packaging and sterile barrier validation: Aligned with ISO 11607 requirements.

The standard also prescribes specific test solutions and procedures for validated performance testing (Clause 5).

Practical applications

ISO 8637-3:2024 is used to:

• Guide manufacturers in designing and verifying single‑use plasmafilters for therapeutic plasmapheresis.
• Support quality and regulatory teams preparing technical documentation, sterility validation and biological evaluation data.
• Provide clinicians, procurement and hospital device committees with objective information on device performance (filtration rate, sieving behavior, blood volume and pressure characteristics) for safe selection and clinical use.

Who should use this standard

• Medical device manufacturers of plasmafilters
• Regulatory affairs and quality assurance professionals
• Test laboratories performing haemocompatibility, sterility and performance tests
• Clinical engineers and hospital procurement teams evaluating plasmapheresis devices

Related standards

• ISO 8637-1 and ISO 8637-2 (other parts of the extracorporeal blood purification series)
• ISO 10993 series (biological evaluation)
• ISO 11607 (packaging for terminally sterilized devices)
• ISO 80369-7 / ISO 80369-20 (small‑bore connector specifications and tests)

Keywords: ISO 8637-3:2024, plasmafilters, plasma filter, extracorporeal systems, blood purification, plasmapheresis, haemocompatibility, sterility, sieving coefficient, plasma filtration rate.