DIN EN ISO 8637-2:2025-08
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2025); German and English version prEN ISO 8637-2:2025 / Note: Date of issue 2025-07-11*Intended as replacement for DIN EN ISO 8637-2 (2024-09).
| Fecha edición: |
2025-08-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration. This document does not apply to: - haemodialysers, haemodiafilters or haemofilters; - plasmafilters; - haemoperfusion devices; - vascular access devices. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1. NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3. |
| Keywords: | Accompanying forms|Biological hazards|Blood|Blood cleansing|Circulation|Circulatory system|Colour codes|Definitions|Dialysis|Dimensions|Extracorporeal|Filters|Haemodiafiltration|Haemodialysers|Haemodialysis equipment|Haemofiltration|Instrument transformers|Liquids|Marking|Mechanical properties|Medical devices|Medical equipment|Medical sciences|Protective devices|Specification (approval)|Specifications|Sterility|Testing |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: |
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