ISO 8637-3:2024
(Main)Extracorporeal systems for blood purification — Part 3: Plasmafilters
Extracorporeal systems for blood purification — Part 3: Plasmafilters
This document specifies requirements and test methods for plasmafilters, which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to; — extracorporeal blood circuits; — haemodialysers, haemodiafilters, haemofilters and haemoconcentrators; — haemoperfusion devices; — vascular access devices; — blood pumps; — systems or equipment intended to perform plasma separation. NOTE 1 Requirements for the extracorporeal blood circuit are specified in ISO 8637-2. NOTE 2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
Systèmes extracorporels pour la purification du sang — Partie 3: Filtres pour plasma
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International
Standard
ISO 8637-3
Second edition
Extracorporeal systems for blood
2024-05
purification —
Part 3:
Plasmafilters
Systèmes extracorporels pour la purification du sang —
Partie 3: Filtres pour plasma
Reference number
ISO 8637-3:2024(en) © ISO 2024
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ISO 8637-3:2024(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 8637-3:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Biological safety and haemocompatibility .3
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 .4
4.5 Performance characteristics .5
4.5.1 Plasma filtration rate .5
4.5.2 Sieving coefficient .6
4.5.3 Blood compartment volume .6
4.5.4 Blood compartment pressure drop .6
4.5.5 Haemolytic characteristics .
...
FINAL DRAFT
International
Standard
ISO/FDIS 8637-3
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
2024-02-23
Part 3:
Plasmafilters
Voting terminates on:
2024-04-19
Systèmes extracorporels pour la purification du sang —
Partie 3: Filtres pour plasma
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 8637-3:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 8637-3:2024(en)
International
Standard
ISO/FDIS 8637-3
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
Part 3:
Plasmafilters
Voting terminates on:
Systèmes extracorporels pour la purification du sang —
Partie 3: Filtres pour plasma
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 8637-3:2024(en) © ISO 2024
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 8637-3:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Biological safety and haemocompatibility .3
4.2 Sterility .3
4.3 Non-pyrogenicity .3
4.4 Mechanical characteristics .3
4.4.1 Structural integrity.3
4.4.2 Blood compa
...
ISO/DISFDIS 8637-1:2023(E)
ISO/TC 150/SC 2/WG 5
Secretariat: ANSI
Date: 2024-02-08
Extracorporeal systems for blood purification — —
Part 1:
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
Second edition
Date: 2023-08-03
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ISO #####-#:####(X)
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs
FDIS stage
2 © ISO #### – All rights reserved
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ISO/FDIS 8637-1:2024(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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved
iii
---------------------- Page: 3 ----------------------
ISO/FDIS 8637-1:2024(en)
Contents
Foreword . Error! Bookmark not defined.
Introduction . Error! Bookmark not defined.
1 Scope . Error! Bookmark not defined.
2 Normative references . Error! Bookmark not defined.
3 Terms and definitions . Error! Bookmark not defined.
4 Requirements . Error! Bookmark not defined.
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5 Test methods . Error! Bookmark not defined.
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6 Expiry date . Error! Bookmark not defined.
7 Labelling . Error! Bookmark not defined.
7.1 Labelling on the device . Error! Bookmark not defined.
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8 Packaging . Error! Bookmark not defined.
(informative) Endotoxin transfer assessment . Error! Bookmark not defined.
Bibliography .
...
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