ISO 8637-2:2024

Overview

ISO 8637-2:2024 specifies safety and performance requirements for disposable extracorporeal blood and fluid circuits and associated accessories used with haemodialysis equipment for extracorporeal blood treatment therapies such as haemodialysis, haemodiafiltration and haemofiltration. It applies to single‑use blood and fluid circuits (including fluid circuits) but does not cover haemodialysers/haemodiafilters/haemofilters themselves, plasmafilters, haemoperfusion devices or vascular access devices. The second edition (2024) updates the 2018 edition with revised haemocompatibility testing, a risk‑based approach to structural integrity testing, connector dimensional details and broader scope for disposable fluid circuits.

Key topics and requirements

ISO 8637-2:2024 addresses the full lifecycle of disposable extracorporeal circuits with emphasis on patient safety and device interoperability. Major technical topics include:

• Biological safety and haemocompatibility - requirements and test methods to minimize adverse blood–material interactions.
• Sterility and non‑pyrogenicity - requirements for sterile manufacture and verification of non‑pyrogenic properties.
• Mechanical characteristics - structural integrity, connector interfaces (to haemodialysers and ancillary components), color coding, access ports, blood pathway volume, air capture chamber fill level and transducer protectors.
• Functional characteristics - blood pump system performance, dialysis fluid pump performance, net fluid removal, substitution fluid flow and temperature, dialysis fluid composition and temperature, fluid path occlusion prevention, air‑infusion prevention, pressure monitoring and blood leak detection.
• Expiry, labelling and packaging - device, unit and shipping labelling, required accompanying documentation, and packaging requirements to preserve sterility and function.
• Test methods - standardized methods for verifying compliance with biological, mechanical and functional requirements.

Practical applications and users

This standard is essential for stakeholders involved in the design, manufacture, testing, regulation and procurement of extracorporeal blood treatment consumables:

• Medical device manufacturers designing single‑use extracorporeal blood and fluid circuits and accessories.
• Quality, R&D and regulatory teams preparing conformity documentation, risk assessments and performance testing.
• Test laboratories and notified bodies performing verification against ISO 8637‑2 test methods.
• Hospital procurement and clinical engineering teams assessing compatibility and safety of disposable circuits for haemodialysis systems.
• Standards developers and compliance officers aligning products with international safety requirements.

Related standards

• ISO 8637-1 - requirements for haemodialysers, haemodiafilters and haemofilters.
• ISO 8637-3 - requirements for plasmafilters.
• IEC 60601-2-16 - electrical medical equipment standards referenced for harmonized terms and definitions.

Keywords: ISO 8637-2:2024, extracorporeal blood and fluid circuits, haemodialysers, haemodiafilters, haemofilters, haemoconcentrators, haemodialysis equipment, haemocompatibility, sterility, connectors, blood pump performance, disposable circuits.