EN ISO 11608-2:2022
(Main)Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (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)
This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1.
This document is not applicable to the following:
— needles for dental use;
— pre-attached syringe needles;
— hypodermic needles;
— needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);
— materials that form the medicinal product contact surfaces of the primary container closure.
However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them.
NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608‑3, and hypodermic needles provided separately are covered in ISO 7864.
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 2: Kanülen mit beidseitigem Anschliff (ISO 11608-2:2022)
Dieses Dokument legt Anforderungen und Prüfverfahren für sterile Kanülen mit beidseitigem Anschliff fest, die für den Einmalgebrauch in einigen kanülenbasierten Injektionssystemen (NISs, en: needle-based injection systems) vorgesehen sind, bei denen in Übereinstimmung mit ISO 11608 1 eine nicht integrierte Kanüle mit beidseitigem Anschliff verwendet wird.
Dieses Dokument ist für folgende Produkte nicht anzuwenden:
— Kanülen zum zahnärztlichen Gebrauch;
— vorab befestigte Spritzenkanülen;
— Subkutankanülen;
— Kanülen, die für unterschiedliche Verabreichungswege (z. B. intravenös, intrathekal, intraokular) bestimmt sind;
— Werkstoffe, welche die Kontaktflächen des Primärbehälters zum Arzneimittel bilden.
Auch wenn dieses Dokument bestimmungsgemäß nicht direkt auf diese Kanülenprodukte anzuwenden ist, so enthält es dennoch Anforderungen und Prüfverfahren, die bei deren Entwicklung und Evaluierung unterstützend genutzt werden können.
ANMERKUNG Kanülen, die vom Hersteller in die Flüssigkeitsbahn oder den Behälter integriert bereitgestellt werden, werden in ISO 11608 3 und Subkutankanülen, die separat geliefert werden, werden in ISO 7864 behandelt.
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)
Le présent document spécifie les exigences et les méthodes d'essai pour les aiguilles à deux extrémités pour stylos-injecteurs non réutilisables destinées à être utilisées avec certains systèmes d'injection à aiguille (NIS) utilisant une aiguille à deux extrémités non intégrée conformément à l'ISO 11608-1.
Le présent document ne s'applique pas aux éléments suivants:
— aux aiguilles dentaires;
— aux aiguilles pour seringues prémontées;
— aux aiguilles hypodermiques;
— aux aiguilles destinées à des voies d'administration différentes (par exemple intraveineuses, intrathécales, intraoculaires);
— aux matériaux qui constituent les surfaces de contact du conditionnement primaire du médicament.
Toutefois, bien que le présent document ne soit pas destiné à s'appliquer directement à ces produits à aiguille, il comprend des exigences et des méthodes d'essai qui peuvent être utilisées pour aider à les concevoir et à les évaluer.
NOTE Les aiguilles fournies par le fabricant et intégrées dans le chemin de fluide ou le conteneur sont traitées dans l'ISO 11608-3, et les aiguilles hypodermiques fournies séparément sont traitées dans l'ISO 7864.
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 2. del: Dvostranske igle (ISO 11608-2:2022)
Ta dokument določa zahteve in preskusne metode za dvostranske sterilne igle za enkratno uporabo, ki so predvidene za uporabo skupaj z nekaterimi peresi za injiciranje (NIS), pri katerih se uporablja neintegrirana dvostranska igla v skladu s standardom ISO 11608-1. Ta dokument se ne uporablja za: igle za zobozdravstveno uporabo; – igle, predhodno nameščene na injekcijsko brizgo; – podkožne igle; – igle, namenjene drugim dovajalnim potem (npr. intravenozno, intratekalno, intraokularno); – materiale, iz katerih so izdelane površine primarnega sistema zapiranja vsebnika, ki pridejo v stik z zdravilom. Ta dokument se sicer ne navezuje neposredno na zgoraj navedene igle, vendar pa vsebuje zahteve in preskusne metode, ki jih je mogoče uporabiti kot pomoč pri njihovi zasnovi in ocenjevanju. OPOMBA: Igle, ki jih dobavi proizvajalec in so integrirane v pot tekočine ali vsebnik, obravnava standard ISO 11608-3, ločeno dobavljene podkožne igle pa obravnava standard ISO 7864.
General Information
Relations
Standards Content (Sample)
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
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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) .
...
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