BS EN ISO 8637:2014 - Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

BS EN ISO 8637:2014

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

Status : Withdrawn   Published : March 2014 Replaced By : BS EN ISO 8637-1:2020

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ISO 8637:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.




Standard NumberBS EN ISO 8637:2014
TitleCardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
StatusWithdrawn
Publication Date31 March 2014
Withdrawn Date21 April 2020
Normative References(Required to achieve compliance to this standard)ISO 10993-4:2017, ISO 10993-7, ISO 594-2, ISO 10993-1, ISO 10993-11
Informative References(Provided for Information)ISO 11137-1, ISO 11135-1, ISO 15223-2, ISO 17665-2, ISO 15223-1, ISO/TS 11135-2, ISO 14937, ISO 11137-2, ISO 8638, 93/42/EEC, ISO 7000, ISO 11137-3:2017, ISO 17665-1
Replaced ByBS EN ISO 8637-1:2020
ReplacesBS EN 1283:1996
International RelationshipsISO 8637:2010,ISO 8637,EN ISO 8637:2014
Draft Superseded By13/30280718 DC
DescriptorsSterile equipment, Pressure testing, Instructions for use, Biological filters, Pipe fittings, Performance testing, Dialysis, Haematology, Dimensions, Fluids handling equipment (medical), Fluid inlets, Medical equipment, Fluid outlets, Concentrators, Blood, Test equipment, Artificial kidneys, Disposable, Filters, Artificial organs, Filtration, Leak tests
ICS11.040.40
Title in FrenchImplants cardiovasculaires et systèmes extracorporels. Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs
Title in GermanKardiovaskuläre Implantate und extrakorporale Systeme. Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren
CommitteeCH/150/2
ISBN978 0 580 82488 3
PublisherBSI
FormatA4
DeliveryYes
Pages34
File Size1.307 MB
Price£214.00


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