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Normas DIN – AENOR
DIN EN ISO 8637:2014-03

DIN EN ISO 8637:2014-03

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01); German version EN ISO 8637:2014

Implants cardiovasculaires et systèmes extracorporels - Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs (ISO 8637:2010, Amendement 1:2013-04-01 inclus); Version allemande EN ISO 8637:2014

Kardiovaskuläre Implantate und extrakorporale Systeme - Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren (ISO 8637:2010, einschließlich Änderung 1:2013-04-01); Deutsche Fassung EN ISO 8637:2014

Fecha Anulación:
2020-10 /Withdrawn
Equivalencias internacionales:

EN ISO 8637 (2014-01)

ISO 8637 AMD 1 (2013-04)

ISO 8637 (2010-07)

TS EN ISO 8637 (2015-05-04)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 8637-1:2020-10

Reemplaza a: DIN EN ISO 8637:2013-06

Reemplaza a: DIN EN 1283:1996-06

Resumen:
This standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans. This standard is not applicable to: - extracorporeal blood circuits; - plasmafilters; - haemoperfusion devices; - vascular access devices; - blood pumps; - pressure monitors for the extracorporeal blood circuit; - air detection devices; - systems to prepare, maintain or monitor dialysis fluid; - systems used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; - reprocessing procedures and equipment. NOTE: Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in EN ISO 8638.
Keywords:
Blood, Blood cleansing, Definitions, Dialysis, Dimensions, Extracorporeal, Haemodiafiltration, Haemodialysers, Haemodialysis equipment, Haemofiltration, Marking, Medical devices, Medical equipment, Medical sciences, Specifications, Testing
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