BS EN ISO 8637:2014 PDF

Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

First page of standard BS EN ISO 8637:2014

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Title (English):

BS EN ISO 8637:2014

Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Document status:: Withdrawn
Format:: Electronic (PDF)
Publication date:: March 31, 2014
ICS:: 11.040.40
Technical committee:: CEN
SKU:: BS EN ISO 8637:2014

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Abstract

1 Scope This International Standard specifies requirements for haemodialysers , haemodiafilters , haemofilters and haemoconcentrators , hereinafter collectively referred to as “the device”, for use in humans. This International Standard is not applicable 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 used to perform haemodialysis , haemodiafiltration , haemofiltration or haemoconcentration ;

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Abstract

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