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SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 11608-2:2012
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 2. del:
Dvostranske igle (ISO 11608-2:2022)
Needle-based injection systems for medical use - Requirements and test methods - Part
2: Double-ended pen needles (ISO 11608-2:2022)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 2: Kanülen mit beidseitigem Anschliff (ISO 11608-2:2022)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 2: Aiguilles à deux extrémités pour stylos-injecteurs (ISO 1608-2:2022)
Ta slovenski standard je istoveten z: EN ISO 11608-2:2022
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11608-2
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 11608-2:2012
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 2: Double-ended
pen needles (ISO 11608-2:2022)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 2: Aiguilles à Verwendung - Anforderungen und Prüfverfahren - Teil
deux extrémités pour stylos-injecteurs (ISO 1608- 2: Kanülen mit beidseitigem Anschliff (ISO 11608-
2:2022) 2:2022)
This European Standard was approved by CEN on 2 January 2022.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-2:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11608-2:2022) has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and catheters" 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 November 2022, and conflicting national standards
shall be withdrawn at the latest by November 2022.
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 supersedes EN ISO 11608-2:2012.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11608-2:2022 has been approved by CEN as EN ISO 11608-2:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 11608-2
Third edition
2022-04
Needle-based injection systems for
medical use — Requirements and test
methods —
Part 2:
Double-ended pen needles
Systèmes d'injection à aiguille pour usage médical — Exigences et
méthodes d'essai —
Partie 2: Aiguilles à deux extrémités pour stylos-injecteurs
Reference number
ISO 11608-2:2022(E)
ISO 11608-2:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii
ISO 11608-2:2022(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 3
5 Requirements . 3
5.1 Needle tube requirements . 3
5.1.1 General . 3
5.1.2 Needle tubing materials . . . 4
5.1.3 Tubing characteristics . 4
5.2 Double-ended pen needle requirements . 4
5.2.1 General . 4
5.2.2 Biocompatibility . 4
5.2.3 Dimensions for double-ended pen needle assembly . 4
5.2.4 Needle points . 5
5.2.5 Freedom from defects . 5
5.2.6 Flow rate through the needle. 5
5.2.7 Bond between hub and needle tube . 6
5.2.8 Dislocation of measuring point at patient end . 7
5.2.9 Ease of assembly . 7
5.2.10 Sterility . 7
5.2.11 Pyrogenicity . 8
5.3 Functional compatibility with NISs . 8
5.3.1 General . 8
5.3.2 Dose delivery . 8
5.3.3 Needle removal torque . 9
6 Sampling .10
7 Preconditioning of needles .13
7.1 Preconditioning in a dry-heat, cold storage and damp heat atmosphere .13
7.2 Preconditioning in a cyclical atmosphere . 13
8 Standard atmosphere and test apparatus .13
8.1 Standard test atmosphere .13
8.2 Test gauge . 13
8.3 Test apparatus. 14
9 Test methods .14
9.1 Bond between hub and needle tube . 14
9.2 Determination of dislocation of measuring point at patient end . 14
9.3 Ease of assembly .15
9.4 Functional compatibility with NISs . 15
9.4.1 Sample quantity requirements . 15
9.4.2 Test procedures for testing dose delivery . 16
9.4.3 Procedure for testing needle hub removal torque . 17
10 Packaging.17
11 Information supplied with the needle(s) .
...