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

ISO-8637-3 - 2ND EDITION - CURRENT
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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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Document Number

ISO 8637-3:2024

Revision Level

2ND EDITION

Status

Current

Publication Date

May 1, 2024

Committee Number

ISO/TC 150/SC 2