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Normas DIN – AENOR
DIN EN ISO 8637-2:2018-12

DIN EN ISO 8637-2:2018-12

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018

Systèmes extracorporels pour la purification du sang - Partie 2: Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8637-2:2018); Version allemande EN ISO 8637-2:2018

Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8637-2:2018); Deutsche Fassung EN ISO 8637-2:2018

Fecha:
2018-12 /Active
Equivalencias internacionales:

EN ISO 8637-2 (2018-08)

ISO 8637-2 (2018-07)

Relación con otras normas DIN:
Resumen:
This International Standard specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This standard is not applicable to: - haemodialysers, haemodiafilters or haemofilters; - 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 or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3 NOTE Extracoproreal blood tubing sets may also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.
Keywords:
Accompanying forms, Biological hazards, Blood, Blood cleansing, Circulatory system, Colour codes, Definitions, Dialysis, Dimensions, Extracorporeal, Filters, Haemodiafiltration, Haemodialysers, Haemodialysis equipment, Haemofiltration, Instrument transformers, Marking, Mechanical properties, Medical devices, Medical equipment, Medical sciences, Protective devices, Specification (approval), Specifications, Sterility, Testing
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