ISO 8637-3-2024 PDF

Full title and description

St ISO 8637-3:2024 — Extracorporeal systems for blood purification — Part 3: Plasmafilters. This international standard specifies requirements and test methods for sterile, single‑use plasmafilters intended to separate plasma from blood for therapeutic plasmapheresis in humans.

Abstract

The document sets out essential requirements, test methods and labelling expectations for plasmafilters used in extracorporeal blood purification. It covers design and performance characteristics relevant to safety and effectiveness and excludes other extracorporeal components such as extracorporeal blood circuits, haemodialysers and blood pumps.

General information

• Status: Published (International Standard).
• Publication date: 31 May 2024 (Edition 2, 2024).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Medical equipment and supplies — extracorporeal systems for blood purification).
• Edition / version: Edition 2 (2024).
• Number of pages: 18 pages (official edition).

Scope

ISO 8637-3:2024 applies to sterile, single‑use plasmafilters intended for therapeutic plasmapheresis in humans. It specifies which devices are in scope and explicitly excludes items such as extracorporeal blood circuits, haemodialysers, haemodiafilters, haemofilters, haemoconcentrators, haemoperfusion devices, vascular access devices, blood pumps and systems or equipment intended solely to perform plasma separation.

Key topics and requirements

• General requirements and normative references for plasmafilters (definitions and terms).
• Design and performance requirements addressing plasma separation function, safety and sterility for single‑use devices.
• Specified test methods to verify performance, integrity and safety (including relevant biological and sterilization considerations).
• Labelling and information for use requirements (packaging, instructions, symbols and warnings).
• References to related biological evaluation and sterilization standards used to support testing and compliance.

Typical use and users

Used by medical device manufacturers, quality and regulatory teams, clinical engineers, hospital procurement and clinical staff involved in therapeutic plasmapheresis. The standard is referenced during design, testing, risk assessment and regulatory submissions for single‑use plasmafilters intended for human therapeutic use.

Related standards

ISO 8637-3 is part of the ISO 8637 series on extracorporeal systems for blood purification. It cross‑references and is commonly used alongside standards for sterilization and biological evaluation such as ISO 11137 (radiation sterilization), ISO 10993 (biological evaluation of medical devices), ISO 15223 (labelling symbols) and other device‑specific parts of ISO 8637 (Parts 1 and 2).

Keywords

plasmafilters; extracorporeal systems; blood purification; plasmapheresis; single‑use medical devices; test methods; labelling; sterility; ISO 8637.

FAQ

Q: What is this standard?

A: ISO 8637-3:2024 is an international standard that specifies requirements and test methods for plasmafilters used in therapeutic plasmapheresis (sterile, single‑use devices for separating plasma from blood).

Q: What does it cover?

A: It covers definitions, general requirements, test methods and labelling for plasmafilters, and lists exclusions (other extracorporeal components and systems). It also points to relevant normative references for biological evaluation and sterilization.

Q: Who typically uses it?

A: Medical device manufacturers, test laboratories, regulatory and quality professionals, procurement specialists and clinical engineers involved in development, testing, conformity assessment and clinical deployment of plasmafilters.

Q: Is it current or superseded?

A: Current — ISO 8637-3:2024 (Edition 2) was published in 2024 and replaces earlier editions; the standard is listed as published and subject to periodic review.

Q: Is it part of a series?

A: Yes — it is Part 3 of the ISO 8637 series (Extracorporeal systems for blood purification). Other parts cover haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (Part 1) and extracorporeal blood circuits (Part 2).

Q: What are the key keywords?

A: Plasmafilter, plasmapheresis, extracorporeal blood purification, single‑use medical device, test methods, sterility, labelling, ISO 8637.