prEN ISO 8536-13

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO/DIS 8536-13:2023)

ISO 8536-13:2016 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.

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)

ISO 8536-13:2016 spécifie les exigences applicables aux régulateurs de débit gradués non stériles, non réutilisables, utilisés en tant que sous-composants dans les ensembles de perfusion stérilisés non réutilisables pour contrôler le débit des solutions de perfusion intraveineuses avec contact à fluide, à alimentation par gravité.
Dans certains pays, la pharmacopée nationale ou d'autres réglementations nationales présentent un caractère obligatoire et peuvent prévaloir sur l'ISO 8536-13:2016.

Infuzijska oprema za uporabo v medicini - 13. del: Regulatorji graduiranega pretoka za enkratno uporabo pri stiku s tekočino (ISO/DIS 8536-13:2023)

General Information

• Status: Not Published
• Publication Date: 16-Mar-2025
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 4060 - Closure of enquiry - Enquiry
• Start Date: 14-Nov-2023
• Completion Date: 14-Nov-2023
• Ref Project: oSIST prEN ISO 8536-13:2023 - Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO/DIS 8536-13:2023)

Relations

• Revises: EN ISO 8536-13:2016 - Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

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.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 8536-13:2023

---------------------- Page: 2 ----------------------
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
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 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

---------------------- Page: 3 ----------------------
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.
COPYRIGHT PROTECTED DOCUMENT
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
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
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
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 8536-13:2023(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 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 4 ----------------------
oSIST prEN ISO 8536-13:2023
ISO/DIS 8536-13:2023(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references .
...