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BS EN ISO 8637-2:2018

BS EN ISO 8637-2:2018

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Extracorporeal systems for blood purification Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Available format(s)

Hardcopy , PDF

Superseded date

04-17-2024

Language(s)

English

Published date

10-03-2018

Publisher

British Standards Institution

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

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

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 document does not apply to:

  • haemodialysers, haemodiafilters or haemofilters;

  • 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.

NOTE1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO8637‑1, and requirements for plasmafilters are specified in ISO8637‑3.

NOTE2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

Committee
CH/150/2
DocumentType
Standard
ISBN
9780580920110
Pages
22
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN ISO 8637-2:2018 Identical

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Hardcopy - English
PDF - English
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