BS EN ISO 8638:2014 - Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

BS EN ISO 8638:2014

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

Status : Superseded, Withdrawn   Published : March 2014 Replaced By : BS EN ISO 8637-2:2018

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ISO 8638:2010 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.




Standard NumberBS EN ISO 8638:2014
TitleCardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
StatusSuperseded, Withdrawn
Publication Date31 March 2014
Withdrawn Date03 October 2018
Normative References(Required to achieve compliance to this standard)ISO 7864, ISO 10993-4:2017, ISO 10993-7, ISO 10993-11, ISO 10993-1, ISO 594-2
Informative References(Provided for Information)ISO 11137-1, ISO 11135-1, ISO 11137-2, ISO 14937, 93/42/EEC, ISO 15223-2, ISO 17665-2, ISO/TS 11135-2, ISO 15223-1, ISO 8637, ISO 7000, ISO 11137-3:2017, ISO 17665-1
Replaced ByBS EN ISO 8637-2:2018
ReplacesBS EN 1283:1996
International RelationshipsISO 8638,EN ISO 8638:2014
Draft Superseded By13/30280722 DC
DescriptorsFluid inlets, Blood, Sterile equipment, Haematology, Leak tests, Biological filters, Fluids handling equipment (medical), Medical equipment, Dimensions, Test equipment, Pressure testing, Concentrators, Pipe fittings, Instructions for use, Disposable, Artificial kidneys, Filters, Artificial organs, Fluid outlets, Dialysis, Performance testing, Filtration
ICS11.040.40
Title in FrenchImplants cardiovasculaires et systèmes extracorporels. Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres
Title in GermanKardiovaskuläre Implantate und extrakorporale Systeme. Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern
CommitteeCH/150/2
ISBN978 0 580 82489 0
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size351 KB
Price£182.00


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