Norm

NEN-ISO 8637-3:2018 en

Extracorporale systemen voor bloedzuivering - Deel 3: Plasmafilters

80,61 97,54 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 14
Commissie Chirurgische implantaten
Gepubliceerd op 01-09-2018
Taal Engels
NEN-ISO 8637-3 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.

Details

ICS-code 11.040.40
Nederlandse titel Extracorporale systemen voor bloedzuivering - Deel 3: Plasmafilters
Engelse titel Extracorporeal systems for blood purification - Part 3: Plasmafilters
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