EN ISO 11608-3:2012
(Main)Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
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.
INTERNATIONAL ISO
STANDARD 11608-3
Second edition
2012-10-01
Needle-based injection systems for medical
use — Requirements and test methods —
Part 3:
Finished containers
Systèmes d’injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 3: Conteneurs prêts à l’emploi
Reference number
ISO 11608-3:2012(E)
©
ISO 2012
ISO 11608-3:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
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Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 11608-3:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11608-3 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.
This second edition cancels and replaces the first edition (ISO 11608-3:2000), which has been technically revised.
ISO 11608 consists of the following parts, under the general title Needle-based injection systems for medical
use — Requirements and test methods:
— Part 1: Needle-based injection systems
— Part 2: Needles
— Part 3: Finished containers
— Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
— Part 5: Automated functions
ISO 11608-3:2012(E)
Introduction
This part of ISO 11608 is applicable to containers that are provided pre-filled, or that are to be filled by the user
with medicinal products intended by the manufacturer to be used with needle-based injection systems (NIS),
as covered by ISO 11608.
The previous edition of this part of ISO 11608 introduced the concept of interchangeability and the labelling
designation of Type A (i.e. interchangeable) and non-Type A for needles and containers.
Since its publication, experience has shown that the complexity of these systems makes it very difficult to
ensure functional compatibility as defined in this International Standard, particularly when products are made
by different manufacturers and the design is not verified as a system. The “Type A” designation, therefore,
does not represent adequate guidance to the user in making decisions on the compatibility of needles and
containers with specific NIS. As such, the labelling designation of “Type A” has been removed.
The previous edition of this part of ISO 11608 also only addressed cartridges as the drug container. This was
consistent with the scope of ISO 11608 (all parts), which was previously restricted to cartridge-based injection
pens. The scope of the latest revision of ISO 11608 (all parts) has been expanded beyond pen injectors and
now includes all NIS, resulting in additional possibilities for compatible containers, including syringes to be
used with NIS, and potentially other containers not yet defined. In order to preserve this information, this part
of ISO 11608 maintains those specifications, requirements and dimensions. It is important to stress that the
design requirements related to system function have been maintained as a guide to assist manufacturers
during the design phase in supporting the achievement of cross-platform compatibility. However, these design
requirements are an insufficient replacement for system testing of the components and, where possible, direct
communication and/or quality agreements between system component manufacturers. Given the patient
convenience benefits associated with cross-platform compatibility, it is helpful if manufacturers of needles,
containers and NIS label their products with the specific system components that have been tested and
demonstrated to be functionally compatible.
For containers other than cartridges, this part of ISO 11608 can be used as a guide to understand the
parameters and design criteria to be considered in the selection and/or design of containers that will be used
with NIS. It provides performance requirements regarding essential aspects so that variations of design are
not unnecessarily restricted.
The sampling plans for inspection selected for this part of ISO 11608 are intended for design verification at a
high confidence level. The sampling plans for inspection do not replace the more general manufacturing quality
systems that appear in standards on quality management systems, such as the ISO 9000 series and ISO 13485.
There are other international and national standards, guidance materials and, in some countries, national
regulations that are applicable to medical devices and pharmaceuticals; their requirements might supersede or
complement this part of ISO 11608. Developers and manufacturers of NIS are encouraged to investigate and
determine if there are any other requirements relevant to the safety or marketability of their products.
iv © ISO 2012 – All rights reserved
INTERNATIONAL STANDARD ISO 11608-3:2012(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 3:
Finished containers
1 Scope
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 end-
user 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).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11040-3, Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
ISO 11608-1, Needle-based injection systems for medical use — Requirements and test methods — Part 1:
Needle-based injection systems
ISO 11608-2, Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles
ISO 13926-1:2004, Pen systems — Part 1: Glass cylinders for pen-injectors for medical use
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
cap
component which attaches the disc to the cartridge
3.2
cartridge
primary container for the medicinal product
ISO 11608-3:2012(E)
3.3
cylinder
main body of the container
3.4
deliverable volume
contents of the container which are accessible by utilizing the delivery device in accordance with the
instructions for use
NOTE Deliverable volume can be less than fill volume.
3.5
disc
component which seals the end of the container opposite the plunger
3.6
initiating force
break-loose force
force required to dislodge the plunger from its resting position
3.7
label
identification of the contents of the container
3.8
particle-free water
water that has passed through 0,2 micron pore-size filter media
3.9
plunger
component which seals one end of the container and interfaces with the plunger rod of the delivery device
3.10
plunger rod
delivery device mechanism which advances the plunger to deliver the medicinal product
3.11
sustaining force
force required
...
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