ISO 8637-3:2018

Extracorporeal systems for blood purification — Part 3: Plasmafilters

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.

Systèmes extracorporels pour la purification du sang — Partie 3: Filtres pour plasma

General Information

• Status: Withdrawn
• Publication Date: 16-Jul-2018
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
• Drafting Committee: ISO/TC 150/SC 2/WG 5 - Renal replacement, detoxification and apheresis
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 31-May-2024

Relations

• Revised: ISO 8637-3:2024 - Extracorporeal systems for blood purification — Part 3: Plasmafilters
• Effective Date: 25-Feb-2023
• Revises: ISO 13960:2010 - Cardiovascular implants and extracorporeal systems — Plasmafilters
• Effective Date: 05-Nov-2015

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 8637-3
First edition
2018-07
Extracorporeal systems for blood
purification —
Part 3:
Plasmafilters
Systèmes extracorporels pour la purification du sang —
Partie 3: Filtres pour plasma
Reference number
ISO 8637-3:2018(E)
©
ISO 2018

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ISO 8637-3:2018(E)

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ii © ISO 2018 – All rights reserved

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ISO 8637-3:2018(E)

Contents  Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  Requirements . 2
4.1 Biological safety . 2
4.2 Sterility . 3
4.3 Non-pyrogenicity . 3
4.4 Mechanical characteristics. 3
4.4.1 Structural integrity . 3
4.4.2 Blood compartment integrity . 3
4.4.3 Connectors and ports . 3
4.4.4 Volume of the blood compartment . 5
4.4.5 Pressure drop of the blood compartment . 5
4.5 Performance characteristics. 5
4.5.1 Filtration rate . 5
4.5.2 Sieving coefficient . 5
4.5.3 Haemolytic characteristics . 6
4.6 Expiry date.
...