kSIST FprEN ISO 8536-13:2024

SLOVENSKI STANDARD
oSIST prEN ISO 8536-13:2023
01-november-2023
Nadomešča:
SIST EN ISO 8536-13:2017
Infuzijska oprema za uporabo v medicini - 13. del: Regulatorji graduiranega
pretoka za enkratno uporabo pri stiku s tekočino (ISO/DIS 8536-13:2023)
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use
with fluid contact (ISO/DIS 8536-13:2023)
Infusionsgeräte zur medizinischen Verwendung - Teil 13: Graduierte Durchflussregler
zur einmaligen Verwendung mit Flüssigkeitskontakt (ISO/DIS 8536-13:2023)
Matériel de perfusion à usage médical - Partie 13: Régulateurs de débit gradués non
réutilisables avec contact à fluide (ISO/DIS 8536-13:2023)
Ta slovenski standard je istoveten z: prEN ISO 8536-13
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8536-13:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 8536-13:2023
oSIST prEN ISO 8536-13:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8536-13
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-08-22 2023-11-14
Infusion equipment for medical use —
Part 13:
Graduated flow regulators for single use with fluid contact
Matériel de perfusion à usage médical —
Partie 13: Régulateurs de débit gradués non réutilisables avec contact à fluide
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
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NATIONAL REGULATIONS.
ISO/DIS 8536-13:2023(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 2023

oSIST prEN ISO 8536-13:2023
ISO/DIS 8536-13:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8536-13
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:

Infusion equipment for medical use —
Part 13:
Graduated flow regulators for single use with fluid contact
Matériel de perfusion à usage médical —
Partie 13: Régulateurs de débit gradués non réutilisables avec contact à fluide
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
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
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 8536-13:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 8536-13:2023
ISO/DIS 8536-13:2023(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Design . 2
5 Materials . 2
6 Physical requirements . 2
6.1 Graduated scale . . 2
6.2 Particulate contamination . 2
6.3 Tensile strength . 3
6.4 Leakage . 3
6.5 Flow rates . 3
7 Chemical requirements . 3
Annex A (informative) Physical tests . 4
Bibliography . 6
iii
oSIST prEN ISO 8536-13:2023
ISO/DIS 8536-13:2023(E)
Foreword
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This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection
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