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ISO 8637-2:2018

(Main)

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — plasmafilters; — haemoperfusion devices; — vascular access devices; — blood pumps; — pressure monitors for the extracorporeal blood circuit; — air detection devices; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1, and requirements for plasmafilters are specified in ISO 8637‑3. NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

Systèmes extracorporels pour la purification du sang — Partie 2: Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres

Le présent document spécifie les exigences relatives au circuit sanguin des dispositifs utilisés dans le cadre de thérapies avec filtration du sang extracorporelle, notamment, entre autres, pour l'hémodialyse, l'hémodiafiltration et l'hémofiltration, et pour les protecteurs de transducteur (intégrés et non intégrés) destinés à être utilisés dans de tels circuits. Le présent document ne s'applique pas aux: — hémodialyseurs, hémodiafiltres ou hémofiltres; — filtres pour plasma; — dispositifs d'hémoperfusion; — dispositifs d'accès vasculaire; — pompes sanguines; — moniteurs de pression du circuit sanguin extracorporel; — dispositifs de détection d'air; — systèmes de préparation, de conservation ou de contrôle du liquide de dialyse; — systèmes ou à l'équipement destinés à effectuer une hémodialyse, une hémodiafiltration, une hémofiltration ou une hémoconcentration. NOTE 1 Les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs sont spécifiées dans l'ISO 8637‑1, et les exigences concernant les filtres pour plasma sont indiquées dans l'ISO 8637‑3. NOTE 2 Des tubulures de transfusion extracorporelles peuvent également être utilisées pour d'autres thérapies extracorporelles telles que l'hémoperfusion, la plasmafiltration et l'adsorption de plasma.

General Information

Status
Withdrawn
Publication Date
19-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
08-Apr-2024
Ref Project

Relations

Revised
ISO 8637-2:2024 - Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Effective Date
23-Apr-2020
Revises
ISO 8638:2010 - Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Effective Date
05-Nov-2015

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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 8637-2
First edition
2018-07
Extracorporeal systems for blood
purification —
Part 2:
Extracorporeal blood circuit for
haemodialysers, haemodiafilters and
haemofilters
Systèmes extracorporels pour la purification du sang —
Partie 2: Circuit sanguin extracorporel pour les hémodialyseurs, les
hémodiafiltres et les hémofiltres
Reference number
ISO 8637-2:2018(E)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 8637-2:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 8637-2:2018(E)

Contents  Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
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 Connectors to haemodialyser, haemodiafilter or haemofilter . 3
4.4.3 Connectors to vascular access device . 3
4.4.4 Connectors to ancillary components . 3
4.4.5 Colour coding . 3
4.4.6 Access ports . 5
4.4.7 Blood pathway volume . 5
4.4.8 Air capture chamber fill level . 5
4.4.9 Transducer protectors . 5
4.4.10 Blood pathway flow d
...

NORME ISO
INTERNATIONALE 8637-2
Première édition
2018-07
Systèmes extracorporels pour la
purification du sang —
Partie 2:
Circuit sanguin extracorporel pour les
hémodialyseurs, les hémodiafiltres et
les hémofiltres
Extracorporeal systems for blood purification —
Part 2: Extracorporeal blood circuit for haemodialysers,
haemodiafilters and haemofilters
Numéro de référence
ISO 8637-2:2018(F)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 8637-2:2018(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2018
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
Fax: +41 22 749 09 47
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2018 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 8637-2:2018(F)

Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Exigences . 3
4.1 Sécurité biologique . 3
4.2 Stérilité . 3
4.3 Apyrogénicité . 3
4.4 Caractéristiques mécaniques . 3
4.4.1 Intégrité structurale . 3
4.4.2 Raccords de l’hémodialyseur, de l’hémodiafiltre ou de l’hémofiltre . 3
4.4.3 Raccords du dispositif d’accès vasculaire . 3
4.4.4 Raccords des composants auxiliaires . 3
4.4.5 Code couleur . 4
4.4.6 Orifices d’accès . 5
4.4.7 Volume du compartiment sanguin . 5
4.4.8 Niveau de remplissage de la chambre de capture d’air . 5
4.4.9 Protecteurs de transducteur . 5
4.4.10 Dynamique d’écoulement du compartiment sanguin .
...

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