EN ISO 8638:2014

Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)

Publication date:   Mar 17, 2014

General information

99.60 Withdrawal effective   Aug 22, 2018

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 1283:1996

NOW

WITHDRAWN
EN ISO 8638:2014
99.60 Withdrawal effective
Aug 22, 2018

REVISED BY

WITHDRAWN
EN ISO 8637-2:2018

Relations

Adopted from ISO 8638:2010 IDENTICAL