Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)

ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.

Infusionsgeräte zur medizinischen Verwendung - Teil 14: Klemmen und Durchflussregler für Transfusions- und Infusionsgeräte ohne Flüssigkeitskontakt (ISO 8536-14:2016)

Matériel de perfusion à usage médical - Partie 14: Clamps et limiteurs de débit pour appareils de transfusion et de perfusion sans contact à fluide (ISO 8536-14:2016)

ISO 8536-14:2016 spécifie les exigences applicables aux clamps non stériles et aux limiteurs de débit utilisés en tant que sous-composants pour réguler le débit des solutions intraveineuses et/ou des composants sanguins dans les appareils de perfusion et de transfusion sanguine stérilisés et dans les poches de sang sans contact à fluide.
Dans certains pays, la pharmacopée nationale ou d'autres réglementations nationales présentent un caractère obligatoire et peuvent prévaloir sur l'ISO 8536-14:2016.

Infuzijska oprema za uporabo v medicini - 14. del: Sponke in regulatorji pretoka transfuzijskih in infuzijskih naprav brez stika s tekočino (ISO 8536-14:2016)

Ta del standarda ISO 8536 določa zahteve za naprave, ki se uporabljajo za nadzor pretoka intravenoznih raztopin in/ali krvnih sestavin prek kompletov za infuzijo in transfuzijo krvi ter sestavov vrečk za kri brez stika s tekočino. Takšne komponente so lahko sestavni del medicinskega pripomočka ali »samostojne« komponente.

General Information

Status
Published
Publication Date
06-Feb-2018
Withdrawal Date
27-Feb-2021
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
07-Feb-2018
Completion Date
07-Feb-2018

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-14:2018
01-april-2018
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO6SRQNHLQUHJXODWRUMLSUHWRND
WUDQVIX]LMVNLKLQLQIX]LMVNLKQDSUDYEUH]VWLNDVWHNRþLQR ,62
Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion
and infusion equipment without fluid contact (ISO 8536-14:2016)
Infusionsgeräte zur medizinischen Verwendung - Teil 14: Klemmen und Durchflussregler
für Transfusions- und Infusionsgeräte ohne Flüssigkeitskontakt (ISO 8536-14:2016)
Matériel de perfusion à usage médical - Partie 14: Clamps et limiteurs de débit pour
appareils de transfusion et de perfusion sans contact à fluide (ISO 8536-14:2016)
Ta slovenski standard je istoveten z: EN ISO 8536-14:2018
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-14:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 8536-14:2018

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

SIST EN ISO 8536-14:2018


EN ISO 8536-14
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2018
EUROPÄISCHE NORM
ICS 11.040.20
English Version

Infusion equipment for medical use - Part 14: Clamps and
flow regulators for transfusion and infusion equipment
without fluid contact (ISO 8536-14:2016)
Matériel de perfusion à usage médical - Partie 14: Infusionsgeräte zur medizinischen Verwendung - Teil
Clamps et limiteurs de débit pour appareils de 14: Klemmen und Durchflussregler für Transfusions-
transfusion et de perfusion sans contact à fluide (ISO und Infusionsgeräte ohne Flüssigkeitskontakt (ISO
8536-14:2016) 8536-14:2016)
This European Standard was approved by CEN on 19 December 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-14:2018 E
worldwide for CEN national Members.

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SIST EN ISO 8536-14:2018
EN ISO 8536-14:2018 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

2

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SIST EN ISO 8536-14:2018
EN ISO 8536-14:2018 (E)
European foreword
This document (EN ISO 8536-14:2018) has been prepared by Technical Committee ISO/TC 76
“Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2018, and conflicting national standards shall
be withdrawn at the latest by February 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
Acc
...

SLOVENSKI STANDARD
oSIST prEN ISO 8536-14:2015
01-september-2015
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO6SRQNHLQUHJXODWRUMLSUHWRND
WUDQVIX]LMVNLKLQLQIX]LMVNLKQDSUDYEUH]VWLNDVWHNRþLQR ,62',6
Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion
and infusion equipment without fluid contact (ISO/DIS 8536-14:2015)
Infusionsgeräte zur medizinischen Verwendung - Teil 14: Klemmen und Durchflussregler
für Transfusions- und Infusionsgeräte ohne Flüssigkeitskontakt (ISO/DIS 8536-14:2015)
Matériel de perfusion à usage médical - Partie 14 : Crochets et limiteur de débit pour
appareils de transfusion et infusion sans contact à fluide (ISO/DIS 8536-14:2015)
Ta slovenski standard je istoveten z: prEN ISO 8536-14
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8536-14:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 8536-14:2015

---------------------- Page: 2 ----------------------
oSIST prEN ISO 8536-14:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8536-14
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2015-06-25 2015-09-25
Infusion equipment for medical use —
Part 14:
Clamps and flow regulators for transfusion and infusion
equipment without fluid contact
Matériel de perfusion à usage médical —
Partie 14: Crochets et limiteur de débit pour appareils detransfusion et infusion sans contact à fluide
ICS: 11.040.20
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
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 8536-14:2015(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 2015

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oSIST prEN ISO 8536-14:2015
ISO/DIS 8536-14:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 8536-14:2015
ISO/DIS 8536-14:2015(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Design .
...

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