Overview
EN ISO 8637-2:2024 (adopted by CEN) specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used with haemodialysis equipment for extracorporeal blood treatment therapies - including haemodialysis, haemodiafiltration, haemofiltration. It covers safety, functional performance, mechanical characteristics, sterilization and labelling for circuits used with haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. The standard is the CEN-endorsed version of ISO 8637-2:2024 and supersedes EN ISO 8637-2:2018.
Note: this part does not apply to haemodialysers/filters themselves, plasmafilters, haemoperfusion devices or vascular access devices.
Key topics and requirements
The document defines technical requirements and test methods across these major areas:
- Biological safety & haemocompatibility - materials and design considerations to minimise adverse blood–material interactions.
- Sterility and non‑pyrogenicity - requirements for sterilization and verification to ensure patient safety.
- Mechanical characteristics - structural integrity, connector compatibility (to haemodialysers/filters, vascular access devices and ancillary components), colour coding, access ports and transducer protectors.
- Functional performance - blood pump system performance, dialysis fluid pump performance, net fluid removal accuracy, substitution fluid flow, dialysis/substitution fluid composition and temperature control.
- Air and occlusion protection - prevention of air infusion, air capture chamber fill-level criteria and fluid path occlusion detection.
- Monitoring and alarms - pressure monitoring and blood leak detection capabilities required for safe operation.
- Volume and expiry - blood pathway volume specifications and requirements for expiry dating and labelling.
- Test methods and labelling - defined procedures to verify conformity and mandatory device labelling information for users.
These topics are accompanied by standardized test methods to demonstrate compliance and by labelling requirements for safe use.
Applications and users
Who benefits from EN ISO 8637-2:2024:
- Manufacturers of disposable extracorporeal circuits and accessories - for product design, verification and regulatory compliance.
- Regulatory and conformity assessment bodies - for assessing device safety/performance.
- Testing laboratories - to perform standardized mechanical, biological and functional tests.
- Procurement and clinical engineering teams in dialysis clinics and hospitals - to specify devices that meet recognized safety and performance criteria.
- Healthcare providers and risk managers - to understand device limitations, labelling and expiry requirements.
Keywords: EN ISO 8637-2:2024, extracorporeal blood and fluid circuits, haemodialysis, haemodiafilters, haemofilters, haemoconcentrators, haemocompatibility, sterility, blood pump performance, pressure monitoring.
Related standards
- ISO 8637-1 - requirements for haemodialysers, haemodiafilters and haemofilters.
- ISO 8637-3 - requirements for plasmafilters.
These related parts should be consulted together when selecting or designing complete extracorporeal blood purification systems.
