ISO/FDIS 8637-3
u
ISO/FDIS 8637-3
86614

Status : Under development

Abstract

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.

General information

  •  : Under development
    : Final text received or FDIS registered for formal approval [50.00]
  •  : 2
     : 18
  • ISO/TC 150/SC 2
    11.040.40 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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