SIST EN ISO 8536-14:2018

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

This part of ISO 8536 specifies requirements for devices used to control the flow of intravenous solutions and/or blood components through infusion and blood transfusion sets and blood bag assemblies without fluid contact. Such components may be an integral part of a medical device or a ‘stand-alone’ component.

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
• Public Enquiry End Date: 19-Sep-2015
• Publication Date: 18-Feb-2018
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 03-Jan-2017
• Due Date: 10-Mar-2017
• Completion Date: 19-Feb-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 8536-14:2018 - Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)

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.

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SIST EN ISO 8536-14:2018

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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.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the United Kingdom.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA”, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between normative references and dated EN and ISO standards
Normative references as listed in
Equivalent dated standard
Clause 2 of the ISO standard
 EN ISO or IEC
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
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SIST EN ISO 8536-14:2018
EN ISO 8536-14:2018 (E)
Endorsement notice
The text of ISO 8536-14:2016 has been approved by CEN as EN ISO 8536-14:2018 without any
modification.

4

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SIST EN ISO 8536-14:2018
EN ISO 8536-14:2018 (E)
Annex ZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission's standardization request [M/295
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169]
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC. This means that risks have to be
reduced “as far as possible”, “to a minimum”, “to the lowest possible level”, “minimized” or “removed”, according
to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
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SIST EN ISO 8536-14:2018
EN ISO 8536-14:2018 (E)
Table ZA.1 — Correspondence between this European standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/subclause(s) of this
Remarks/Notes
Directive 93/42/EEC EN
7.2 4, 5, 6 Clause 4 covers ER 7.2 in respect
of controlling fluid flow and
avoiding puncturing of flexible
tubing only.
Clause 5 covers ER 7.2 in respect
of material physical performance
as follows:
• Tubing specifications
• Operating temperature
• Construction
• Flow rates
Clause 6 covers ER 7.2 in respect
of the following items only:
• Tubing specifications
• Operating temperature
• Construction
• Flow rates
The part of ER 7.2 relating to
packaging is not addressed.
7.5 6.3, A.1 Clause 6.3 covers ER 7.5, first
para, first sentence in respect of
controlling the flow rate of
substances being delivered via
the infusion set only.
A.1 covers ER 7.5, first para, first
sentence in respect of
controlling the flow rate of
substances being delivered via
the infusion set only.
ER 7.5, first para, second
sentence and ER 7.5, paragraphs
two and three are not covered.
7.6 6.3, A.1 ER 7.6 is covered by Clause 6.3
but only to the extent that the
clamp must ensure complete
occlusion of the fluid pathway.
ER 7.6 is covered by A.1 but only
to the extent that the clamp must
ensure complete occlusion of the
fluid pathway.
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SIST EN ISO 8536-14:2018
EN ISO 8536-14:2018 (E)
9.1 4 ER 9.1 is covered by Clause 4 in
respect of the design of the
clamp so that accidental
operation of the clamp is
avoided and flexible tubing is not
damaged during operation only.
12.7.1 4 ER 12.7.1 is covered by Clause 4
in respect of the design of the
clamp so that accidental
operation of the clamp is
avoided and flexible tubing is not
damaged during operation only.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to the European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.

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SIST EN ISO 8536-14:2018

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SIST EN ISO 8536-14:2018
INTERNATIONAL ISO
STANDARD 8536-14
First edition
2016-11-15
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: Clamps et limiteurs de débit pour appareils de transfusion
et de perfusion sans contact à fluide
Reference number
ISO 8536-14:2016(E)
©
ISO 2016

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SIST EN ISO 8536-14:2018
ISO 8536-14:2016(E)

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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2016 – All rights reserved

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SIST EN ISO 8536-14:2018
ISO 8536-14:2016(E)

Contents Page
Foreword .iv
1 Scope .
...