ISO 8637-1:2024
(Main)Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to: — extracorporeal blood circuits; — plasmafilters; — haemoperfusion devices; — vascular access devices; — blood pumps; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; — reprocessing procedures and equipment. NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2. NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
Systèmes extracorporels pour la purification du sang — Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs
L'ISO 8637-1:2017 spécifie les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs, collectivement appelés ci-après «dispositifs», utilisables chez l'homme. L'ISO 8637-1:2017 ne s'applique pas: - aux circuits sanguins extracorporels; - aux filtres pour plasma; - aux dispositifs d'hémoperfusion; - aux dispositifs d'accès vasculaire; - aux pompes sanguines; - aux moniteurs de pression du circuit sanguin extracorporel; - aux dispositifs de détection d'air; - aux systèmes de préparation, de conservation ou de contrôle du liquide de dialyse; - aux systèmes ou à l'équipement destinés à effectuer une hémodialyse, une hémodiafiltration, une hémofiltration ou une hémoconcentration; - aux modes opératoires et au matériel de retraitement. NOTE Les exigences relatives au circuit sanguin extracorporel pour les hémodialyseurs, hémodiafiltres et hémofiltres sont spécifiées dans l'ISO 8637‑2.
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International
Standard
ISO 8637-1
Second edition
Extracorporeal systems for blood
2024-05
purification —
Part 1:
Haemodialysers, haemodiafilters,
haemofilters and
haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et
hémoconcentrateurs
Reference number
ISO 8637-1:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
ISO 8637-1:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved
ii
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ISO 8637-1:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 5
4.1 Biological safety and haemocompatibility .5
4.2 Sterility .5
4.3 Non-pyrogenicity .5
4.4 Mechanical characteristics .6
4.4.1 Structural integrity.6
4.4.2 Blood compartment integrity .6
4.4.3 Blood compartment connectors of haemodialysers, haemodiafilters and
haemofilters . .6
4.4.4 Dialysis fluid compartment connectors of haemodialysers and haemodiafilters .7
4.4.5 Filtrate connectors of haemofilters .8
4.4.6 Blood and filtrate connectors of haemoconcentrators.8
4.5 Performance characteristics .9
4.5.1 Solute clearance for haemodialysers and haemodiafilters .9
4.5.2 Sieving coefficients for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators .
...
FINAL DRAFT
International
Standard
ISO/FDIS 8637-1
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
2024-02-23
Part 1:
Haemodialysers, haemodiafilters,
Voting terminates on:
2024-04-19
haemofilters and
haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et
hémoconcentrateurs
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
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.
Reference number
ISO/FDIS 8637-1:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 8637-1:2024(en)
International
Standard
ISO/FDIS 8637-1
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
Part 1:
Haemodialysers, haemodiafilters,
Voting terminates on:
haemofilters and
haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et
hémoconcentrateurs
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 8637-1:2024(en) © ISO 2024
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 8637-1:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 5
4.1 Biological safety and haemocompatibility .5
4.2 Sterility .5
4.3 Non-pyrogenicity .5
4.4 Mechanical characteristics .6
4.4.
...
ISO/DTS 12901-1:2023(E)
Second edition
2023-09-01
ISO/TC 229
Secretariat: BSI
Date: 2024-02-08
Nanotechnologies — Occupational risk management applied to
engineered nanomaterials —
Part 1:
Principles and approaches
Nanotechnologies — Gestion du risque professionnel appliquée aux nanomatériaux manufacturés —
Partie 1: Principes et approches
---------------------- Page: 1 ----------------------
ISO/DTS 12901-1:(en)
© ISO 20232024
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
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/DTS 12901-1:(en)
Contents
Foreword . Error! Bookmark not defined.
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2 Normative references . Error! Bookmark not defined.
3 Terms and definitions . Error! Bookmark not defined.
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...
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