ISO 8637-2

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — plasmafilters; — haemoperfusion devices; — vascular access devices. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1. NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.

Systèmes extracorporels pour la purification du sang — Partie 2: Circuits sanguins extracorporels et liquidiens pour les hémodialyseurs, les hémodiafiltres, les hémofiltres et les hémoconcentrateurs

Le présent document spécifie les exigences relatives aux circuits sanguins extracorporels et liquidiens jetables et aux accessoires utilisés conjointement avec un appareil d’hémodialyse destiné aux thérapies avec traitement du sang extracorporel, notamment, entre autres, l’hémodialyse, l’hémodiafiltration et l’hémofiltration. Le présent document ne s’applique pas aux: — hémodialyseurs, hémodiafiltres ou hémofiltres; — filtres pour plasma; — dispositifs d’hémoperfusion; — dispositifs d’accès vasculaire. NOTE 1 Les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs sont spécifiées dans l’ISO 8637‑1. NOTE 2 Les exigences relatives aux filtres pour plasma sont spécifiées dans l’ISO 8637‑3.

General Information

• Status: Not Published
• 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: 6000 - International Standard under publication
• Completion Date: 15-Nov-2023

Relations

• Consolidates: ISO 15471:2016 - Surface chemical analysis — Auger electron spectroscopy — Description of selected instrumental performance parameters
• Effective Date: 06-Jun-2022
• Revises: ISO 8637-2:2018 - Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
• Effective Date: 23-Apr-2020

Standards Content (Sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 8637-2
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
2023-09-19
Part 2:
Voting terminates on:
Extracorporeal blood and fluid circuits
2023-11-14
for haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 2: Circuits sanguins extracorporels et liquidiens pour
les hémodialyseurs, les hémodiafiltres, les hémofiltres et les
hémoconcentrateurs
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 8637-2:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 1 ----------------------
ISO/FDIS 8637-2:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 8637-2
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
Part 2:
Voting terminates on:
Extracorporeal blood and fluid circuits
for haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 2: Circuits sanguins extracorporels et liquidiens pour
les hémodialyseurs, les hémodiafiltres, les hémofiltres et les
hémoconcentrateurs
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
ISO/CEN PARALLEL PROCESSING
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 8637-2:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 2 ----------------------
ISO/FDIS 8637-2:2023(E)
Contents  Page
Foreword .v
Introduction . vi
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
4  Requirements . 6
4.1 General . 6
4.2 Biological safety and haemocompatibility . 6
4.3 Sterility . 6
4.4 Non-pyr
...

ISO/FDIS 8637--2:2023(E)
ISO/TC 150/SC 2
Secretariat: ANSI
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid
circuits for haemodialysers, haemodiafilters haemofilters and haemoconcentrators
Systèmes extracorporels pour la purification du sang — Partie 2: Circuit sanguin extracorporel et
fluide pour les Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs
Second edition
Date: 2023-09-04-22

---------------------- Page: 1 ----------------------
ISO/FDIS 8637-2:2023(E)
© ISO 2023
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’sISO'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
Email: [e-mail] [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/FDIS 8637-2:2023(E)
Contents
Foreword . 5
Introduction . 7
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 7
4.1 General . 7
4.2 Biological safety and haemocompatibility . 7
4.3 Sterility . 7
4.4 Non-pyrogenicity . 7
4.5 Mechanical characteristics . 8
4.5.1 Structural integrity . 8
4.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter . 8
4.5.3 Connectors to vascular access device . 12
4.5.4 Connectors to ancillary components . 12
4.5.5 Colour coding . 12
4.5.6 Access ports . 13
4.5.7 Blood pathway volume . 13
4.5.8 Air capture chamber fill level . 13
4.5.9 Transducer protectors . 13
4.6 Functional characteristics . 13
4.6.1 General . 13
4.6.2 Blood pump system performance . 14
4.6.3 Dialysis fluid pump performance . 14
4.6.4 Net fluid removal .
...