Reference number
ISO 8637-3:2018
© ISO 2025
ISO 8637-3:2018
Extracorporeal systems for blood purification — Part 3: Plasmafilters
Edition 1
2018-07
Withdrawn
Withdrawn (Edition 1, 2018)

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

  • Status
     : Withdrawn
    Publication date
     : 2018-07
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 14
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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