Overview

ISO 8637-1:2024 - "Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators" specifies safety, performance and test requirements for these blood purification devices intended for human use. This second edition updates terminology, revises test methods (including an example for endotoxin transfer), and clarifies labelling and documentation expectations. The standard focuses on the device itself and excludes whole dialysis systems and several accessory items (see Related Standards).

Key topics and technical requirements

The standard defines mandatory requirements and test methods across these areas:

Biological safety and haemocompatibility: evaluation in line with ISO 10993 series to reduce adverse blood–material interactions.
Sterility and non‑pyrogenicity: requirements and test methods for terminal sterilization and endotoxin control.
Mechanical characteristics:
- Structural integrity and blood compartment integrity to prevent leaks or air ingress.
- Standardized blood compartment connectors and fluid connectors to ensure compatibility.
Performance characteristics and measurements:
- Solute clearance (haemodialysers, haemodiafilters).
- Sieving coefficients (all listed devices) to quantify solute transfer.
- Ultrafiltration rate and ultrafiltration coefficient for fluid removal performance.
- Blood compartment volume and pressure drop across the device.
- Endotoxin transfer assessment to guard against pyrogenic risk.
Shelf life, labelling and packaging: required information on device, container and accompanying documentation to support safe use and reprocessing instructions (where applicable).

The document provides specific test methods (Section 5) for each requirement and aligns dimensional specifications to ensure compatibility with extracorporeal circuits detailed in ISO 8637‑2.

Applications and who uses this standard

ISO 8637-1:2024 is essential for:

Medical device manufacturers designing and validating haemodialysers, haemodiafilters, haemofilters and haemoconcentrators.
Test laboratories performing conformity, sterility and performance testing.
Regulatory bodies and notified bodies evaluating submissions and compliance.
Biomedical engineers and procurement teams assessing device compatibility and safety for clinical settings.
R&D teams developing next‑generation blood purification membranes and modules.

Adoption helps ensure device safety, interoperability with extracorporeal circuits, reliable performance and clear labelling for clinical use.

Related standards

ISO 8637-2: extracorporeal blood circuits (compatibility with blood port dimensions)
ISO 8637-3: plasmafilters
ISO 10993 series: biological evaluation of medical devices
ISO 11607-1/2: packaging for terminally sterilized medical devices
ISO 14971: risk management for medical devices
ISO 20417, ISO 17664‑1, ISO 80369‑7 (connectors)

Keywords: ISO 8637-1:2024, haemodialyser, haemodiafilter, haemofilter, haemoconcentrator, extracorporeal blood purification, dialysis standards, sterility, haemocompatibility, ultrafiltration, sieving coefficient, endotoxin transfer.

Overview

Key topics and technical requirements

The standard defines mandatory requirements and test methods across these areas:

Biological safety and haemocompatibility: evaluation in line with ISO 10993 series to reduce adverse blood–material interactions.
Sterility and non‑pyrogenicity: requirements and test methods for terminal sterilization and endotoxin control.
Mechanical characteristics:
- Structural integrity and blood compartment integrity to prevent leaks or air ingress.
- Standardized blood compartment connectors and fluid connectors to ensure compatibility.
Performance characteristics and measurements:
- Solute clearance (haemodialysers, haemodiafilters).
- Sieving coefficients (all listed devices) to quantify solute transfer.
- Ultrafiltration rate and ultrafiltration coefficient for fluid removal performance.
- Blood compartment volume and pressure drop across the device.
- Endotoxin transfer assessment to guard against pyrogenic risk.
Shelf life, labelling and packaging: required information on device, container and accompanying documentation to support safe use and reprocessing instructions (where applicable).

The document provides specific test methods (Section 5) for each requirement and aligns dimensional specifications to ensure compatibility with extracorporeal circuits detailed in ISO 8637‑2.

Applications and who uses this standard

ISO 8637-1:2024 is essential for:

Medical device manufacturers designing and validating haemodialysers, haemodiafilters, haemofilters and haemoconcentrators.
Test laboratories performing conformity, sterility and performance testing.
Regulatory bodies and notified bodies evaluating submissions and compliance.
Biomedical engineers and procurement teams assessing device compatibility and safety for clinical settings.
R&D teams developing next‑generation blood purification membranes and modules.

Adoption helps ensure device safety, interoperability with extracorporeal circuits, reliable performance and clear labelling for clinical use.

Related standards

ISO 8637-2: extracorporeal blood circuits (compatibility with blood port dimensions)
ISO 8637-3: plasmafilters
ISO 10993 series: biological evaluation of medical devices
ISO 11607-1/2: packaging for terminally sterilized medical devices
ISO 14971: risk management for medical devices
ISO 20417, ISO 17664‑1, ISO 80369‑7 (connectors)

ISO 8637-1:2024 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Похожие стандарты

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