oSIST prEN ISO 8637-2:2023

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022)

Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO/DIS 8637-2:2022)

Dieses Dokument legt Anforderungen an extrakorporale Blut- und Flüssigkeitskreisläufe und Zubehör für den einmaligen Gebrauch fest, die in Kombination mit Hämodialysegeräten für extrakorporale Blutbehandlungstherapien wie z. B. Hämodialyse, Hämodiafiltration und Hämofiltration verwendet werden, jedoch nicht darauf beschränkt sind.
Dieses Dokument gilt nicht für:
   Hämodialysatoren, Hämodiafilter, Hämofilter;
   Plasmafilter;
   Hämoperfusionsgeräte;
   Geräte für den vaskulären Zugang.
ANMERKUNG 1   Die Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren sind in ISO 8637 1 spezifiziert.
ANMERKUNG 2   Die Anforderungen an Plasmafilter sind in ISO 8637 3 spezifiziert.

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/DIS 8637-2:2022)

Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni in tekočinski obtok za hemodializatorje, hemodiafiltre, hemofiltre in hemokoncentratorje (ISO/DIS 8637-2:2022)

General Information

• Status: Not Published
• Public Enquiry End Date: 14-Jan-2023
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 09-Oct-2023
• Due Date: 27-Nov-2023
• Ref Project: FprEN ISO 8637-2 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/FDIS 8637-2:2023)

Relations

• Revised: SIST EN ISO 8637-2:2018 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
• Effective Date: 25-Dec-2019
• Revised: SIST EN ISO 8637-2:2018 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
• Effective Date: 19-Jan-2023
• Revised: SIST EN ISO 8637-2:2018 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 8637-2:2023
01-januar-2023
Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni in
tekočinski obtok za hemodializatorje, hemodiafiltre, hemofiltre in
hemokoncentratorje (ISO/DIS 8637-2:2022)
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid
circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
(ISO/DIS 8637-2:2022)
Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blutkreislauf bei
Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO/DIS 8637-2:2022)
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/DIS 8637-2:2022)
Ta slovenski standard je istoveten z: prEN ISO 8637-2
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8637-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 8637-2:2023

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oSIST prEN ISO 8637-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8637-2
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-10-24 2023-01-16
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 pour les hémodialyseurs, les hémodiafiltres et les hémofiltres
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8637-2:2022(E)
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 SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 8637-2:2023
ISO/DIS 8637-2:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8637-2
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:

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 pour les hémodialyseurs, les hémodiafiltres et les hémofiltres
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 8637-2:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 8637-2:2023
ISO/DIS 8637-2:2022(E)
Contents Page
Foreword .
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