Standard

NEN-ISO 8637-3:2018 en

Extracorporeal systems for blood purification - Part 3: Plasmafilters

80,61 97,54 Incl BTW

About norm

Status Current
Number of pages 14
Committee Chirurgische implantaten
Published on 01-09-2018
Language English
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
Dutch title Extracorporale systemen voor bloedzuivering - Deel 3: Plasmafilters
English title Extracorporeal systems for blood purification - Part 3: Plasmafilters
Replaces

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