ISO 8637-2; Extracorporeal blood circuit for Haemodialysers, Haemodiafilters and Haemofilters
ISO 8637-2; Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8637-2 Foreword
The first edition of ISO 8637-2:2018 cancels and replaces ISO 8638, which has been technically revised. The following changes have been made: Figure 1, Figure 2, and Figure 3 have been revised.
ISO 8637-2 Introduction
This document is concerned with the extracorporeal blood circuit manufactured for single use and intended for use in conjunction with haemodialysers, haemodiafilters and haemofilters. The requirements specified in this document for the extracorporeal blood circuit will help to ensure safety and satisfactory function.
It was not found practicable to specify materials of construction. This document therefore requires only that materials have been tested and that the methods and results are made available upon request.
The dimensions of the connectors intended for connecting the extracorporeal blood circuit to a haemodialyser, haemodiafilter or haemofilter have been revised and specified to ensure compatibility with these devices, as specified in ISO 8637-1. The design and dimensions have been selected in order to minimize the risk of leakage of blood and ingress of air. Connectors with either fixed or loose locking shells are permitted.
This document reflects the consensus of physicians, manufacturers and other interested parties for devices that are approved for clinical use.
ISO 8637-2 Scope
This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.
This International Standard does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— pressure monitors for the extracorporeal blood circuit;
— air detection devices;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3.
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Original Posting: 10/20/2020
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