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ILNAS-EN ISO 8637:2014 Edition 01/2014
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
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  • 36.2 / copy
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Abstract

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

Status

Standard - Superseded

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project      date of ratification (dor)    01/12/2013
end of the vote on the project      date of anouncement (doa)    30/04/2014
start of the vote on the final project    30/05/2013   date of publication (dop)    31/07/2014
end of the vote on the final project    30/10/2013   date of withdrawal (dow)    31/07/2014


Publication Official Journal
of the Grand-Duchy of Luxembourg
06/05/2014
Reference

Relations

Evolutions
ILNAS-EN ISO 8637-2:2018
ILNAS-EN ISO 8637-1:2020

Relations to older standards
ILNAS-EN 1283:1996

International Classification for Standards (ICS codes) :

11.040.40 : Implants for surgery, prosthetics and orthotics

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