ISO 8637-1; Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
ISO 8637-1; Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-1 Foreword
The first edition of ISO 8637-1:2017 cancels and replaces ISO 8637, which has been technically revised. The following changes have been made: Figure 1, Figure 2, and Figure 3 have been revised.
ISO 8637-1 Introduction
This document is concerned with devices intended for haemodialysis, haemodiafiltration, haemofiltration and haemoconcentration in humans. The requirements specified in this document 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 which have been used have been tested and that the methods and results are made available upon request. There is no intention to specify, or to set limits on, the performance characteristics of the devices because such restrictions are unnecessary for the qualified user and would limit the alternatives available when choosing a device for a specific application.
The dimensions of the blood ports and the dialysis fluid or filtrate ports have been specified to ensure compatibility of the device with the extracorporeal blood circuit specified in ISO 8637-2. The design and dimensions have been selected in order to minimize the risk of leakage of blood and the ingress of air.
This document reflects th e consensus of physicians, manufacturers and other interested parties for devices that are approved for clinical use. Conformance with this document is voluntary and it does not supersede any national regulation.
ISO 8637-2 Scope
This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
This International Standard does not apply to:
- extracorporeal blood circuits;
- plasma filters;
- 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
- reprocessing procedures and equipment.
Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
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Original Posting: 10/20/2020
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