DIN EN ISO 8637-1:2020-10
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017); German version EN ISO 8637-1:2020
| Fecha edición: |
2020-10-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| 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 ISO 8637-2. |
| Keywords: | Biological hazards|Blood|Blood cleansing|Definitions|Dialysis|Dimensions|Extracorporeal|Features|Haemodiafiltration|Haemodialysers|Haemodialysis equipment|Haemofiltration|Marking|Mechanical properties|Medical devices|Medical equipment|Medical sciences|Safety|Specifications|Testing |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 8637-1:2020 Idéntica ISO 8637-1:2017 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 8637:2014-03 Reemplaza a DIN EN ISO 8637-1:2016-05 |










