ISO 8637-1-2024 PDF

Full title and description

St ISO 8637-1-2024 — Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. This standard specifies safety, performance and test requirements for sterile, single‑use devices intended to perform blood purification functions (haemodialysis, haemodiafiltration, haemofiltration and haemoconcentration) when used in humans.

Abstract

ISO 8637-1:2024 defines essential requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (collectively “the device”). The document covers design and construction, materials, labelling, performance (including hydraulic and separation characteristics), biocompatibility, sterility and packaged integrity, and required tests to verify conformance. The standard explicitly excludes extracorporeal blood circuits (covered in Part 2), plasmafilters (covered in Part 3), haemoperfusion devices, vascular access devices, blood pumps and complete dialysis systems or fluid preparation systems.

General information

• Status: Published / Current
• Publication date: 31 May 2024
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics; extracorporeal systems)
• Edition / version: Edition 2 (2024)
• Number of pages: 31

Scope

This part of ISO 8637 specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators intended for single‑use in human therapies. It sets out mandatory safety and performance criteria, test procedures and acceptance criteria for functional performance, biocompatibility, sterility and packaging. The standard does not apply to extracorporeal blood circuits (see ISO 8637-2), plasmafilters (see ISO 8637-3), haemoperfusion devices, vascular access devices, blood pumps, pressure monitors, air detectors, systems to prepare or monitor dialysis fluid, complete dialysis machines, or procedures/equipment for reprocessing devices.

Key topics and requirements

• Device definition and classification: scope of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators and intended use statements.
• Materials and construction: selection of blood‑contacting materials, chemical resistance, and manufacturing controls to minimize leachables/extractables.
• Biocompatibility: requirements and reference to ISO 10993 series (biological evaluation and relevant tests for blood interaction and systemic toxicity).
• Sterility and packaging: requirements for terminal sterilization, sterility assurance, microbial limits, and package integrity suitable for sterile single‑use devices.
• Performance testing: hydraulic performance, transmembrane pressure, ultrafiltration characteristics (e.g., Kuf), clearance/separation performance, sieving coefficients, priming volume and maximum allowable flows/pressures.
• Leakage and integrity tests: mechanical strength, pressure/leak tests and resistance to collapse or rupture under specified conditions.
• Labelling and instructions for use: mandatory information, symbols, warnings, shelf life, storage and handling instructions, and compatibility notes (e.g., intended extracorporeal circuit restrictions).
• FAT and verification: factory tests and sample test methods to verify conformity with declared performance.
• Safety and risk management: requirement to apply a risk management process consistent with medical device practice to address hazards associated with blood purification therapy.

Typical use and users

ISO 8637-1:2024 is used by manufacturers and designers of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators to develop, test and document devices for regulatory submission and market access. Testing and validation laboratories, conformity assessment bodies, notified bodies/registries and regulatory authorities use the standard to assess device performance and safety. Clinical engineers, procurement teams at dialysis centres and healthcare technology assessment groups also refer to the standard when evaluating products.

Related standards

Commonly referenced and related standards include: ISO 8637-2 (extracorporeal blood and fluid circuits), ISO 8637-3 (plasmafilters), the ISO 10993 series (biocompatibility: ISO 10993-1, ISO 10993-4, ISO 10993-11, etc.), ISO 11137 (sterilization of health care products — radiation), ISO 11607 (packaging for terminally sterilized medical devices), ISO 13485 (quality management for medical devices), and ISO 15223 (symbols for medical device labelling). Regulatory guidance and local medical device regulations should be consulted alongside these standards.

Keywords

haemodialyser, haemodiafilter, haemofilter, haemoconcentrator, extracorporeal, dialysis, ultrafiltration, transmembrane pressure, sieving coefficient, priming volume, biocompatibility, sterility, single-use medical device

FAQ

Q: What is this standard?

A: ISO 8637-1:2024 is an international standard that defines requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators used in human blood purification therapies.

Q: What does it cover?

A: It covers device definition, material and construction requirements, biocompatibility considerations, sterility and packaging, performance and integrity tests (hydraulic and separation performance), labelling and instructions for safe use, and verification methods. It excludes extracorporeal circuits, plasmafilters and complete dialysis machines.

Q: Who typically uses it?

A: Device manufacturers, design engineers, test laboratories, conformity assessment bodies, regulatory reviewers, clinical engineers and procurement specialists in dialysis services.

Q: Is it current or superseded?

A: ISO 8637-1:2024 is the current edition published 31 May 2024; it supersedes ISO 8637-1:2017.

Q: Is it part of a series?

A: Yes. ISO 8637 is a multipart series addressing extracorporeal blood purification devices. Relevant parts include ISO 8637-1 (this document), ISO 8637-2 (extracorporeal blood and fluid circuits) and ISO 8637-3 (plasmafilters).

Q: What are the key keywords?

A: Haemodialyser, haemodiafilter, haemofilter, haemoconcentrator, extracorporeal, dialysis, ultrafiltration, biocompatibility, sterility, sieving coefficient, transmembrane pressure.