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ISO 8637-3:2018

Extracorporeal systems for blood purification — Part 3: Plasmafilters

Standard Details

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Status : WITHDRAWN
Standard Type: Main
Document No: ISO 8637-3:2018
Document Year: 2018
Pages: 14
Edition: 1
  • Section Volume:
  • ISO/TC 150/SC 2. Cardiovascular implants and extracorporeal systems
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

Life Cycle

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WITHDRAWN
ISO 8637-3:2018
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