EN ISO 11608-3:2012

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)

This part of ISO 11608 specifies the functional and design considerations for containers to be used with
needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and
multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser
integrated in the NIS or assembled with the NIS at the time of use.
This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use
in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential
containers, including syringes to be used with a NIS.
This part of ISO 11608 is not applicable to cartridges intended for dental use.
Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this
part of ISO 11608.
NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 3: Fertigbehälter (ISO 11608-3:2012)

Dieser Teil der ISO 11608 legt die Überlegungen zu Funktionsweise und Gestaltung für Behälter zur Verwendung mit kanülenbasierten Injektionssystemen (NIS) fest, die die Spezifikationen der ISO 11608 1 erfüllen. Sie ist anwendbar auf Einzeldosis  und Mehrfachdosisbehälter (befüllt durch den Hersteller oder den Endanwender), die dem Endanwender bereits in das NIS integriert oder zum Einfügen in das NIS zum Zeitpunkt der Verwendung zur Verfügung gestellt werden können.
Dieser Teil der ISO 11608 schließt Spezifikationen und Prüfverfahren zum Beschreiben und Bewerten von Kartuschen zur Verwendung in NIS mit Pen Nadeln (wie in ISO 11608 2 definiert) ein und umreißt die Gestaltungsüberlegungen für weitere mögliche Behälter, einschließlich Spritzen, sofern sie mit einem NIS zu verwenden sind.
Dieser Teil der ISO 11608 gilt nicht für Kartuschen, die für den zahnärztlichen Gebrauch bestimmt sind.
Getrennt verkaufte und nicht für die Benutzung in einem NIS vorgesehene Spritzen und Kanülen liegen nicht im Anwendungsbereich dieses Teils der ISO 11608.
ANMERKUNG   Siehe ISO 7864 (Kanülen), ISO 8537 (Insulinspritzen) und ISO 7886-1 (Spritzen zum manuellen Gebrauch).

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 3: Conteneurs prêts à l'emploi (ISO 11608-3:2012)

La présente partie de l'ISO 11608 spécifie les considérations fonctionnelles et de conception des conteneurs
à utiliser avec les systèmes d'injection à base d'aiguille (NIS) qui satisfont aux spécifications de l'ISO 11608‑1.
Elle s'applique aux conteneurs à dose unique ou multidoses (remplis par le fabricant ou par l'utilisateur final)
pouvant être fournis à l'utilisateur final intégrés dans le NIS ou assemblés avec le NIS au moment de l'utilisation.
La présente partie de l'ISO 11608 comprend des spécifications et méthodes d'essai pour décrire et évaluer
les cartouches destinées à être utilisées dans les NIS avec des aiguilles à stylos (telles que définies dans
l'ISO 11608‑2) et indique des considérations de conception pour les autres conteneurs potentiels, y compris
les seringues lorsqu'elles sont destinées à être utilisées avec un NIS.La présente partie de l'ISO 11608 ne
s'applique pas aux cartouches pour usage dentaire.
Les seringues et les aiguilles vendues séparément et non destinées à être utilisées dans un NIS sont exclues
du domaine d'application de la présente partie de l'ISO 11608.
NOTE Voir l'ISO 7864 (aiguilles), l'ISO 8537 (seringues à insuline) et l'ISO 7886-1 (seringues manuelles).

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 3. del: Končna embalaža (ISO 11608-3:2012)

Ta del standarda ISO 11608 določa obravnavo funkcij in izdelave posodic, ki se uporabljajo za peresa za injiciranje (NIS), ki izpolnjujejo specifikacije standarda ISO 11608-1. Uporablja se pri posodicah za enega ali več odmerkov (lahko jih napolni proizvajalec ali uporabnik), ki se lahko ponudijo končnemu uporabniku in so vsebovane v peresih za injiciranje ali se jih sestavi ob času uporabe. Ta del standarda ISO 11608 vsebuje specifikacije in preskusne metode za opis in oceno vložkov, ki se uporabljajo za peresa za injiciranje z iglami (kot je določeno v standardu ISO 11608-2) ter določa smernice za izdelavo drugih možnih posodic, vključno z brizgalkami za uporabo s peresi za injiciranje. Ta del standarda ISO 11608 se ne uporablja za vložke za zobozdravniško uporabo. Brizgalke in igle, ki se prodajajo posebej in niso namenjene uporabi s peresi za injiciranje, v tem delu standarda ISO 11608 niso obravnavane.

General Information

• Status: Withdrawn
• Publication Date: 30-Sep-2012
• Withdrawal Date: 03-May-2022
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 04-May-2022
• Ref Project: SIST EN ISO 11608-3:2013 - Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)

Relations

• Replaces: EN ISO 11608-3:2000 - Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods (ISO 11608-3:2000)
• Effective Date: 22-Dec-2008
• Replaced By: 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)
• Effective Date: 11-May-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11608-3:2013
01-januar-2013
1DGRPHãþD
SIST EN ISO 11608-3:2001
3HUHVD]DLQMLFLUDQMH]DXSRUDERYPHGLFLQL=DKWHYHLQSUHVNXVQHPHWRGHGHO
.RQþQDHPEDODåD,62
Needle-based injection systems for medical use - Requirements and test methods - Part
3: Finished containers (ISO 11608-3:2012)
Pen-Injektoren zur medizinischen Anwendung - Teil 3: Fertigkarpulen - Anforderungen
und Prüfverfahren (ISO 11608-3:2012)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 3: Réservoirs finis (ISO 11608-3:2012)
Ta slovenski standard je istoveten z: EN ISO 11608-3:2012
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11608-3:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11608-3:2013

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SIST EN ISO 11608-3:2013


EUROPEAN STANDARD
EN ISO 11608-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2012
ICS 11.040.25 Supersedes EN ISO 11608-3:2000
English Version
Needle-based injection systems for medical use - Requirements
and test methods - Part 3: Finished containers (ISO 11608-
3:2012)
Systèmes d'injection à aiguille pour usage médical - Nadelbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 3: Conteneurs prêts Verwendung - Anforderungen und Prüfverfahren - Teil 3:
à l'emploi (ISO 11608-3:2012) Fertigbehälter (ISO 11608-3:2012)
This European Standard was approved by CEN on 29 September 2012.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-3:2012: E
worldwide for CEN national Members.

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SIST EN ISO 11608-3:2013
EN ISO 11608-3:2012 (E)
Contents Page
Foreword .3

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SIST EN ISO 11608-3:2013
EN ISO 11608-3:2012 (E)
Foreword
This document (EN ISO 11608-3:2012) has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and intravascular 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 April 2013, and conflicting national standards shall be withdrawn at the
latest by April 2013.
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 supersedes EN ISO 11608-3:2000.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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.
Endorsement notice
The text of ISO 11608-3:2012 has been approved by CEN as a EN ISO 11608-3:2012 without any
modification.

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