ISO 8637-3:2018
Systèmes extracorporels pour la purification du sang — Partie 3: Filtres pour plasma
Numéro de référence
ISO 8637-3:2018
Edition 1
2018-07
Annulée
ISO 8637-3:2018
69845
Annulée (Edition 1, 2018)

Résumé

This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included.

It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.

This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.

It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.

Informations générales

  •  : Annulée
     : 2018-07
    : Annulation de la Norme internationale [95.99]
  •  : 1
  • ISO/TC 150/SC 2
    11.040.40 
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