ISO 8637-1:2017
2017-11
Resumen
ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply 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 or equipment intended 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.
Informaciones generales
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Estado: RetiradaFecha de publicación: 2017-11Etapa: Retirada de la Norma Internacional [95.99]
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Edición: 1Número de páginas: 22
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Comité Técnico :ISO/TC 150/SC 2ICS :11.040.40
- RSS actualizaciones
Ciclo de vida
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Anteriormente
RetiradaISO 8637:2010
RetiradaISO 8637:2010/Amd 1:2013
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Ahora
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Revisada por
PublicadoISO 8637-1:2024
