EN ISO 11608-3:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)

This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).
This document is not applicable to the following products:
—    sterile hypodermic needles;
—    sterile hypodermic syringes;
—    sterile single-use syringes, with or without needle, for insulin;
—    containers that can be refilled multiple times;
—    containers intended for dental use;
—    catheters or infusion sets that are attached or assembled separately by the user.

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 3: Behälter und integrierte Flüssigkeitsbahnen (ISO 11608-3:2022, korrigierte Fassung 2023-01)

Dieses Dokument legt Anforderungen und Prüfverfahren für die Designverifizierung von Behältern und integrierten Flüssigkeitsbahnen fest, die mit kanülenbasierten Injektionssystemen (NISs, en: needle-based injection systems) nach ISO 11608 1 verwendet werden.
Es ist anwendbar auf Einzeldosis- und Mehrfachdosisbehälter, die entweder vom Hersteller (Primärbehälter) oder vom Endanwender befüllt (Vorratsbehälter) (z. B. Karpulen, Spritzen) werden, sowie für Flüssigkeitsbahnen, die am Ort der Herstellung in das NIS integriert werden.
Dieses Dokument ist auch anzuwenden für vorgefüllte Spritzen (siehe ISO 11040 8), wenn sie zusammen mit einem NIS verwendet werden (siehe auch den Anwendungsbereich von ISO 11608 1:2022).
Dieses Dokument ist für folgende Produkte nicht anzuwenden:
—   sterile Subkutankanülen;
—   sterile Injektionsspritzen;
—   sterile Spritzen zum Einmalgebrauch, mit oder ohne Kanüle, für Insulin;
—   Behälter, die mehrere Male befüllt werden können;
—   zum zahnärztlichen Gebrauch vorgesehene Behälter;
—   Katheter oder Infusionssets, die vom Benutzer angebracht oder separat zusammengesetzt werden.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 3: Conteneurs et chemins de fluide intégrés (ISO 11608-3:2022, Version corrigée 2023-01)

Le présent document spécifie les exigences et les méthodes d'essai pour vérification de la conception des conteneurs et des chemins de fluide intégrés utilisés avec les systèmes d'injection à aiguille (NIS) conformément à l'ISO 11608-1.
Il est applicable aux conteneurs à dose unique et multidoses, soit remplis par le fabricant (conditionnement primaire) soit par l'utilisateur final (réservoir) (par exemple, cartouches, seringues) et aux chemins de fluide intégrés au NIS au stade de fabrication.
Le présent document est également applicable aux seringues préremplies (voir l'ISO 11040-8) lorsqu'elles sont utilisées avec un NIS (voir également le domaine d'application de l'ISO 11608-1:2022).
Le présent document ne s'applique pas aux produits suivants:
—    aux aiguilles hypodermiques stériles;
—    aux seringues hypodermiques stériles;
—    aux seringues à insuline, stériles, non réutilisables, avec ou sans aiguille;
—    aux conteneurs pouvant être remplis plusieurs fois;
—    aux conteneurs à usage dentaire;
—    aux cathéters ou appareils de perfusion attachés ou assemblés séparément par l'utilisateur.

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 3. del: Vsebniki in integrirane fluidne poti (ISO 11608-3:2022)

Ta dokument določa zahteve in preskusne metode za overjanje zasnove vsebnikov in integriranih poti tekočine, ki se uporabljajo skupaj s peresi za injiciranje (NIS) v skladu s standardom ISO 11608-1. Uporablja se za vsebnike za enega ali več odmerkov, ki jih napolni proizvajalec (primarni sistem zapiranja vsebnika) ali končni uporabnik (rezervoar) (npr. ampule, brizge), ter za poti tekočine, integrirane v peresa za injiciranje v času njihove proizvodnje. Ta dokument se uporablja tudi za predhodno napolnjene brizge (glej standard ISO 11040-8), kadar se te uporabljajo skupaj s peresom za injiciranje (glej tudi področje uporabe standarda ISO 11608-1:2022). Ta dokument se ne uporablja za naslednje izdelke: – sterilne podkožne igle; – sterilne podkožne injekcijske brizge; – sterilne injekcijske brizge za inzulin za enkratno uporabo, z iglo ali brez nje; – vsebniki, ki jih je mogoče napolniti večkrat; – vsebniki za zobozdravstveno uporabo; – katetri in infuzijski seti, ki jih uporabnik pritrdi ali sestavi posebej.

General Information

• Status: Published
• Publication Date: 03-May-2022
• Withdrawal Date: 29-Nov-2022
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 04-May-2022
• Completion Date: 04-May-2022
• Ref Project: SIST EN ISO 11608-3:2022 - Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)

Relations

• Replaces: EN ISO 11608-3:2012 - Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
• Effective Date: 11-May-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 11608-3:2013
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 3. del:
Vsebniki in integrirane fluidne poti (ISO 11608-3:2022)
Needle-based injection systems for medical use - Requirements and test methods - Part
3: Containers and integrated fluid paths (ISO 11608-3:2022)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 3: NIS-Behälter und integrierte Flüssigkeitspfade (ISO 11608-
3:2022)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 3: Conteneurs et chemins de fluide intégrés (ISO 11608-3:2022)
Ta slovenski standard je istoveten z: EN ISO 11608-3:2022
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 11608-3
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 11608-3:2012
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 3: Containers and
integrated fluid paths (ISO 11608-3:2022)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 3: Conteneurs et Verwendung - Anforderungen und Prüfverfahren - Teil
chemins de fluide intégrés (ISO 11608-3:2022) 3: NIS-Behälter und integrierte Flüssigkeitspfade (ISO
11608-3:2022)
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 11608-3:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11608-3:2022) 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 11608-3:2012.
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 11608-3:2022 has been approved by CEN as EN ISO 11608-3:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 11608-3
Third edition
2022-04
Needle-based injection systems for
medical use — Requirements and test
methods —
Part 3:
Containers and integrated fluid paths
Systèmes d'injection à aiguille pour usage médical — Exigences et
méthodes d'essai —
Partie 3: Conteneurs et chemins de fluide intégrés
Reference number
ISO 11608-3:2022(E)
ISO 11608-3:2022(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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 11608-3:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 General . 3
4.2 Container integrity . 4
4.2.1 Container Closure Integrity (CCI) . 4
4.2.2 Resealability — All multi-dose cartridges or reservoirs with discs . 4
4.2.3 Fragmentation (disc coring) – cartridges or reservoirs with discs. 4
4.3 Cannula requirements (as part of the fluid path) . 5
4.3.1 Rigid needles . 5
4.3.2 Soft cannulas . 5
4.4 Fluid line connections . 5
4.5 Medicinal product compatibility . 5
4.5.1 General . 5
4.5.2 Medicinal product compatibility with reservoir and integrated fluid path
materials . 6
4.5.3 Reservoir and integrated fluid path particulate matter . 6
4.5.4 Reservoir and fluid path pyrogenicity . 6
4.5.5 Reservoir and integrated fluid path leachables. 7
4.5.6 Sterilization of the reservoir and/or integrated fluid path . 7
4.6 Medicinal product leakage . 8
5 Test methods . 8
5.1 Resealability for multi-dose cartridges or reservoirs . 8
5.2 Fragmentation (disc coring) – cartridges or reservoirs . 9
5.3 Sub-visible particulates . 10
5.4 Visible particulates . 10
6 Information supplied with the container .10
6.1 General . 10
6.2 Marking on the unit packaging . 10
Annex A (informative) Medicinal product compatibility references – Requirements,
guidance, standards or compendia material .11
Annex B (informative) Historical references to previous editions .14
Annex C (informative) Theoretical support for resealability requirements .17
Annex D (informative) Reservoir and integrated fluid path leachables .20
Annex E (informative) Medicinal product compatibility .22
Annex F (informative) Primary container closure as compared to reservoir and fluid path .24
Bibliography .27
iii
ISO 11608-3:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent r
...