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  • BSI
    BS EN ISO 8637-1:2020 Extracorporeal systems for blood purification - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    Edition: 2024
    $442.60
    / user per year

Description of BS EN ISO 8637-1:2020 2024

WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document does not apply to:

  • extracorporeal blood circuits;

  • plasmafilters;

  • 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;

  • reprocessing procedures and equipment.

NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.

WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document does not apply to:

  • extracorporeal blood circuits;

  • plasmafilters;

  • 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;

  • reprocessing procedures and equipment.

NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.



Standard NumberBS EN ISO 8637-1:2020
TitleExtracorporeal systems for blood purification - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
StatusWithdrawn
Publication Date2024-06-04
Withdrawn Date2024-09-30
ReplacesBS EN ISO 8637:2014
Replaced ByBS ISO 8637-1:2024
Identical National Standard OfEN ISO 8637-1, ISO 8637-1:2017
DescriptorsLeak tests, Filtration, Artificial organs, Filters, Disposable, Artificial kidneys, Test equipment, Blood, Concentrators, Fluid outlets, Medical equipment, Fluid inlets, Fluids handling equipment (medical), Dimensions, Haematology, Dialysis, Performance testing, Pipe fittings, Biological filters, Instructions for use, Pressure testing, Sterile equipment
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/2
ISBN978 0 580 92010 3
PublisherBSI
Pages34

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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