Overview
EN ISO 8637-1:2020 (ISO 8637-1:2017) covers requirements for extracorporeal blood purification devices used in humans: haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. Prepared by ISO/TC 150 and adopted by CEN, this standard defines safety, performance and labelling expectations to help ensure device compatibility and clinical safety. It does not replace national regulation and is voluntary guidance for manufacturers, test laboratories and clinical users.
Key topics and requirements
The standard addresses the following technical areas (high-level - no specific limits are reproduced here):
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Scope & exclusions
- Applies to haemodialysers, haemodiafilters, haemofilters and haemoconcentrators.
- Explicitly excludes extracorporeal blood circuits, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors, air detectors, dialysis fluid systems/equipment and reprocessing procedures.
- Note: requirements for extracorporeal blood circuits are in ISO 8637‑2.
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Biological and material safety
- Requirements for biological safety, sterility and non‑pyrogenicity of device materials and components.
- Manufacturers must document testing methods and results for materials used.
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Mechanical characteristics
- Structural integrity and blood compartment integrity.
- Specifications for blood, dialysis fluid and filtrate ports to minimize leakage and air ingress and to ensure compatibility with extracorporeal circuits.
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Performance characteristics
- Performance testing for solute clearance, sieving coefficient, ultrafiltration coefficient, blood compartment volume and blood-side pressure drop.
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Test methods and expiry
- Defined test methods for the above characteristics and guidance on establishing an expiry date.
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Labelling and documentation
- Required labelling on device, unit and outer containers plus information to accompany the device to support safe clinical use.
Applications - who uses this standard
- Medical device manufacturers designing and validating haemodialysis and haemofiltration devices.
- Regulatory and conformity assessment bodies evaluating device safety and performance.
- Test laboratories performing bench and biological testing per specified methods.
- Hospitals and clinicians selecting compatible devices and understanding device labelling and performance claims.
Related standards
- ISO 8637‑2 - requirements for the extracorporeal blood circuit (compatibility with device port dimensions).
- Applicable ISO/CEN standards covering sterilization, biological evaluation and medical device labelling may also be referenced during compliance and product development.
Keywords: EN ISO 8637-1:2020, ISO 8637-1, haemodialyser, haemodiafilter, haemofilter, haemoconcentrator, extracorporeal systems, blood purification, dialysis standards, medical device requirements.
