Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)

This part of ISO 8536 specifies requirements for single use, gravity feed graduated flow regulators used to control the flow of intravenous infusion solutions.

Infusionsgeräte zur medizinischen Verwendung - Teil 13: Graduierte Durchflussregler zur einmaligen Verwendung mit Flüssigkeitskontakt (ISO 8536-13:2016)

Matériel de perfusion à usage médical - Partie 13: Régulateurs de débit gradués non réutilisables avec contact à fluide (ISO 8536-13:2016)

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 s tekočinskim stikom (ISO 8536-13:2016)

Ta del standarda ISO 8536 določa zahteve za regulatorje graduiranega pretoka za enkratno uporabo za nadzorovanje pretoka intravenoznih infuzijskih raztopin.

General Information

Status
Published
Public Enquiry End Date
19-Sep-2015
Publication Date
28-Nov-2016
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
27-Oct-2016
Due Date
01-Jan-2017
Completion Date
29-Nov-2016

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SLOVENSKI STANDARD
SIST EN ISO 8536-13:2017
01-januar-2017
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SUHWRND]DHQNUDWQRXSRUDERVWHNRþLQVNLPVWLNRP ,62

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use

with fluid contact (ISO 8536-13:2016)

Infusionsgeräte zur medizinischen Verwendung - Teil 13: Graduierte Durchflussregler zur

einmaligen Verwendung mit Flüssigkeitskontakt (ISO 8536-13:2016)

Matériel de perfusion à usage médical - Partie 13: Régulateurs de débit gradués non

réutilisables avec contact à fluide (ISO 8536-13:2016)
Ta slovenski standard je istoveten z: EN ISO 8536-13:2016
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-13:2017 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-13:2017
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SIST EN ISO 8536-13:2017
EN ISO 8536-13
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Infusion equipment for medical use - Part 13: Graduated
flow regulators for single use with fluid contact (ISO 8536-
13:2016)

Matériel de perfusion à usage médical - Partie 13: Infusionsgeräte zur medizinischen Verwendung - Teil

Régulateurs de débit gradués non réutilisables avec 13: Graduierte Durchflussregler zur einmaligen

contact à fluide (ISO 8536-13:2016) Verwendung mit Flüssigkeitskontakt (ISO 8536-

13:2016)
This European Standard was approved by CEN on 17 September 2016.

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, 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: Avenue Marnix 17, B-1000 Brussels

© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-13:2016 E

worldwide for CEN national Members.
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SIST EN ISO 8536-13:2017
EN ISO 8536-13:2016 (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

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SIST EN ISO 8536-13:2017
EN ISO 8536-13:2016 (E)
European foreword

This document (EN ISO 8536-13:2016) 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 April 2017, and conflicting national standards shall be

withdrawn at the latest by April 2017.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN [and/or CENELEC] 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, 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 ISO or

IEC standard, as listed in Table 1.

NOTE The way in which these referenced documents are cited in normative requirements determines the

extent (in whole or in part) to which they apply.
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SIST EN ISO 8536-13:2017
EN ISO 8536-13:2016 (E)

Table 1 — Correlations between undated 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 8536-4 EN ISO 8536-4:2013 + ISO 8536-4:2010 +
A1:2013 Amd.1:2013
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 80000-4 EN ISO 80000-4:2013 ISO 80000-4:2006
Endorsement notice

The text of ISO 8536-13:2016 has been approved by CEN as EN ISO 8536-13:2016 without any

modification.
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SIST EN ISO 8536-13:2017
EN ISO 8536-13:2016 (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 Council 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 as amended by 2007/47/EC. 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.
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 5, 6, 7, 8 Clause 7 and Clause 8 refer to
ISO 8536-4.
The part of ER 7.2 relating to
packaging is not addressed.
7.3 5, 6, 7, 8 Sections 7 and 8 refer to
ISO 8536-4.
ER covered by biological
evaluation.
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SIST EN ISO 8536-13:2017
EN ISO 8536-13:2016 (E)
7.5 6.3, 6.4, A.2, A.3 Only the first sentence is
covered.
Presumption of conformity with
the Essential Requirements
relating to the biological
evaluation can only be provided
if the manufacturer chooses to
apply the ISO 10993- series
standards.
7.6 6.2, 6.3, 6.4, A.1, A.2, A.3
8.1 6.2, 6.3, 6.4, 7, 8, A.1, A.2, A.3 Sections 7 and 8 refer to
ISO 8536-4.
The part of ER 8.1 relating to
handling is not addressed.
Manufacturing processes are not
covered.
The reduction of the risk of
infection is not fully covered.
8.5 6.2, A.1 ER 8.5 is covered by 6.2 only for
particulate contamination.
9.1 4 The second sentence of ER 9.1 is
not addressed.
12.7 6.3, A.2 Only 12.7.1 is addressed.
Only tensile strength is
addressed.

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this 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 8536-13:2017
INTERNATIONAL ISO
STANDARD 8536-13
First edition
2016-10-01
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
Reference number
ISO 8536-13:2016(E)
ISO 2016
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SIST EN ISO 8536-13:2017
ISO 8536-13:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, 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 2016 – All rights reserved
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SIST EN ISO 8536-13:2017
ISO 8536-13:2016(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Design .........................................................................................................................................................

...

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