BS EN ISO 8638:2014

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Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Published By	Publication Date	Number of Pages
BSI	2014	26

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, BSI

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Description

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as “the device”) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. This International Standard does not apply to:

haemodialysers, haemodiafilters or haemofilters;
plasmafilters;
vascular access devices;
blood pumps;
pressure monitors for the extracorporeal blood circuit;
air detection devices;
systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.

NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.

Additional information

Status	Withdrawn
Title	Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Replaces	BS EN 1283:1996
Publisher	BSI
Committee	CH/150/2
Pages	26
Publication Date	2014-03-31
Withdrawn Date	2018-10-03
Replaced By	BS EN ISO 8637-2:2018
ISBN	978 0 580 82489 0
Standard Number	BS EN ISO 8638:2014
Identical National Standard Of	EN ISO 8638:2014, ISO 8638, ISO 8638:2010
Descriptors	Filtration, Performance testing, Dialysis, Fluid outlets, Artificial organs, Filters, Artificial kidneys, Disposable, Instructions for use, Pipe fittings, Concentrators, Pressure testing, Test equipment, Dimensions, Medical equipment, Fluids handling equipment (medical), Biological filters, Leak tests, Haematology, Sterile equipment, Blood, Fluid inlets
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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BS EN ISO 8638:2014

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