British Standards Institution

Source:: ISO
Committee:: CH/150/2 - Cardiovascular implants
Categories:: Transfusion, infusion and injection equipment
Comment period start date:: 07/07/2025
Comment period end date:: 30/08/2025
Number of comments:: 0

Comment by:

30th Aug

Scope

This document specifies requirements and test methods for plasmafilters, which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to;

— extracorporeal blood circuits;

— haemodialysers, haemodiafilters, haemofilters and haemoconcentrators;

— haemoperfusion devices;

— vascular access devices;

— blood pumps;

— systems or equipment intended to perform plasma separation.

NOTE 1 Requirements for the extracorporeal blood circuit are specified in ISO 8637-2.

NOTE 2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

16/04/2025

3. Public Comments

Public Comments start date:

07/07/2025

Public Comments end date:

30/08/2025

Learn more about the standards development process

Standards Development

BS ISO 8637-3 ISO 8637-3 Extracorporeal systems for blood purification. Part 3: Plasmafilters

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