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ISO 8637-3:2018

Extracorporeal systems for blood purification - Part 3: Plasmafilters

standard by International Organization for Standardization , 07/01/2018

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Full Description

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.

 

Product Details

Published:
07/01/2018
File Size:
1 file , 570 KB
Same As:
BS ISO 8637-3:2018
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 8637-3:2018

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    Extracorporeal systems for blood purification - Part 3: Plasmafilters

    • Most Recent

  2. ISO 13960:2010


    Cardiovascular implants and extracorporeal systems - Plasmafilters

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  3. ISO 13960:2003


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