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EN ISO 8637:2014

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)

Publication date:   Mar 17, 2014

General information

99.60 Withdrawal effective   Apr 15, 2020

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

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 1283:1996

NOW

WITHDRAWN
EN ISO 8637:2014
99.60 Withdrawal effective
Apr 15, 2020

REVISED BY

PUBLISHED
EN ISO 8637-1:2020

Relations

Adopted from ISO 8637:2010 IDENTICAL

Adopted from ISO 8637:2010/Amd 1:2013 IDENTICAL