SIST 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 doubleended 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
SIST EN ISO 11608-2:2022
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
SIST EN ISO 11608-2:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11608-2:2022
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SIST EN ISO 11608-2:2022
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.
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SIST EN ISO 11608-2:2022
EN ISO 11608-2:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11608-2:2022
EN ISO 11608-2:2022 (E)
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.
3
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SIST EN ISO 11608-2:2022
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SIST EN ISO 11608-2:2022
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 2022
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SIST EN ISO 11608-2:2022
ISO 11608-2:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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SIST EN ISO 11608-2:2022
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) .17
11.1 General . 17
11.2 Marking . 18
11.2.1 Marking on the unit packaging . 18
11.2.2 Marking on the user packaging . 19
11.3 Instructions for use . 20
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SIST EN ISO 11608-2:2022
ISO 11608-2:2022(E)
Annex A (normative) Determination of flow rate through needle .21
Annex B (informative) Needle bonding strength test method .24
Annex C (informative) Additional background for requirements .25
Bibliography .30
iv
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SIST EN ISO 11608-2:2022
ISO 11608-2:2022(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 rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 11608-2:2012), which has been
technically revised.
The main changes are as follows:
— terminology for ‘needles’ was updated throughout the document and in the title of the document to
‘double-ended pen needles’ in order to more precisely describe the subject of the document;
— where possible, references to other parts of ISO 11608 (all parts) have been made instead of
repeating the content in this document (for example, conditions for preconditioning). Additionally,
changes have been made to align with ISO 11608-1 (e.g. sample sizes and test case matrix) ;
— content within this document has been reorganized to create a separate clause for symbols and
abbreviated terms, to delineate needle tube requirements, double-ended pen needle requirements
and requirements for functional compatibility with needle-based injection systems (NISs), to group
the test method sections into defined sections;
— new figures have been added to more precisely illustrate the dimensions of the double-ended pen
needle and test gauge referred to in this document;
— requirements for biocompatibility and pyrogenicity introduced and acceptance criteria for flow
rate through the needle have been added;
— testing requirements necessary to establish functional compatibility between a specific NIS and
a specific double-ended pen needle were revised to include dose delivery and needle hub removal
force testing;
v
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SIST EN ISO 11608-2:2022
ISO 11608-2:2022(E)
— new annexes have been introduced which provide an example method for testing needle bond force
(Annex B) and additional background for the requirements in this document (Annex C).
A list of all parts in the ISO 11608 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
vi
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SIST EN ISO 11608-2:2022
ISO 11608-2:2022(E)
Introduction
This document covers sterile double-ended needles intended for single use in conjunction with needle-
based injection systems (e.g. pen injectors). These needles are often referred to as pen needles.
The devices described in this document are designed to be used with the devices described in
ISO 11608-1 and ISO 11608-3. This document is intended to be used in conjunction with ISO 11608-1.
The first edition of this document, i.e. ISO 11608-2:2000, introduced the concept of interchangeability
and the labelling designations “Type A” (i.e., interchangeable) and “non-Type A” for needles and
container closure systems. Since its promulgation, experience has shown that the complexity of these
systems makes it very difficult to ensure functional compatibility as defined in the different clauses
of this document, particularly when products are made by different manufacturers and the design
is not verified as a system. Based on this experience, it is believed that the Type A designation does
not represent adequate guidance to the user in making decisions on the compatibility of needles and
container closures with specific needle-based injection systems (NIS). As such, the labelling designation
“Type A” has been removed.
The second edition of this document, i.e. ISO 11608-2:2012, addressed functional compatibility of the
system through testing in accordance with Clause 11 (functional compatibility testing is in Clause 9
in this document). Flow rate was introduced as a new parameter. The sampling plans for inspection
selected for this document and outlined in ISO 11608-1 are intended to verify the design, at a high
confidence level. The sampling plan does not replace the more general manufacturing quality systems,
including lot release, which appear in quality management systems, e.g. ISO 9001 or ISO 13485.
This document refers to ISO 11608-1 for dose accuracy requirements for functional compatibility
and includes requirements for double-ended pen needle device adapted from ISO 7864:2016 and new
requirements for cleanliness (as part of the freedom from defects requirement), biocompatibility and
pyrogenicity testing. After the experience gained through testing for functional compatibility with the
second edition of this document, the testing approach was reassessed to ensure that the appropriate
tests were included. Following a rigorous review of anonymized dose accuracy data generated by
manufacturers over several years, assessing the relationship of dose accuracy and the flow rate through
the pen needle, it was determined that there is no relationship between the pen needle flow rate and
dose accuracy. This further supports the understanding that the primary contributors to dose accuracy
in the NIS system are the NIS and the cartridge.
The needle provides the fluid path from the cartridge to the subcutaneous tissue and its influence
on dose accuracy is mainly affected by the correct position of the needle bevel inside the cartridge, a
possible leakage and indirectly over the injection force and injection time by the flow rate. The inner
diameter has an influence on the time that is needed to deliver the entire volume but not directly to the
precision of the dosage. Additionally, a prescribed holding time may be specified in the NIS IFU, which
provides for completion of dose delivery during expansion and or relaxation of soft parts within the
NIS and cartridge. Therefore, the testing requirements necessary to establish functional compatibility
between a specific NIS and a specific pen needle were revised in this edition to include dose delivery
and needle hub removal force testing. Dose delivery may be demonstrated either through dose accuracy
testing or through confirmation of dose delivery, which includes demonstrating that the needle bevel is
positioned inside the cartridge, visual verification that the dose is expelled and inspection for absence
of leakage at the base of the non-patient end of the cannula.
vii
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SIST EN ISO 11608-2:2022
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SIST EN ISO 11608-2:2022
INTERNATIONAL STANDARD ISO 11608-2:2022(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 2:
Double-ended pen needles
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 9626:2016, Stainless steel needle tubing for the manufacture of medical devices — Requirements and
test methods
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 11608-1:2022, Needle-based injection systems for medical use — Requirements and test methods —
Part 1: Needle-based injection systems
ISO 11608-3:2022, Needle-based injection systems for medical use — Requirements and test methods —
Part 3: Containers and integrated fluid paths
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11608-1 and the following
apply.
1
© ISO 2022 – All rights reserved
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SIST EN ISO 11608-2:2022
ISO 11608-2:2022(E)
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
double-ended pen needle
single-use, double-ended, sterile needles with attachment system specific for some NISs which use a
non-integrated needle
Note 1 to entry: See Figure 1.
Key
1 seal (3.2) l patient-end needle length
1
2 means of needle assembly attachment l cartridge-end needle length
2
3 needle hub l distance from the surface of the seal to the underside of the thread
3
4 needle container l depth of the needle hub
4
5 needle shield (if included) l distance from the underside of the thread to the surface of the
5
hub base
6 needle tube h needle hub union length
1
7 jointing medium (if used) d diameter of needle hub union
1
Figure 1 — Example presentation of double-ended pen needle assembly
3.2
seal
removable barrier which maintains the sterility of the needle inside the needle container
2
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SIST EN ISO 11608-2:2022
ISO 11608-2:2022(E)
3.3
unit packaging
needle container, together with the seal (3.2) forming the packaging of the device, that maintains the
sterility of the needle
3.4
user packaging
device or collection of devices in their respective unit packaging (3.3) provided to the user
4 Symbols
α
Angular distance
1,min
λ
Average wavelength of the visual light
C Calibration constant (used for calculating flow rate using the Extended Hagen–Poiseuille
equation)
d Maximum allowable dislocation
max
D Diameter of the pupil of the eye, where the light is deflected
pupil
D Nominal outside diameter of the needle tube, expressed in millimetres
out
D Outer diameter of the needle tube at the hub (for tapered needles)
out,hub
D Outer diameter of needle tube at the first full diameter from the tip (for tapered needles)
out,tip
...
SLOVENSKI STANDARD
oSIST prEN ISO 11608-2:2020
01-april-2020
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 2. del:
Igle (ISO/DIS 11608-2:2020)
Needle-based injection systems for medical use - Requirements and test methods - Part
2: Needles (ISO/DIS 11608-2:2020)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 2: Kanülen (ISO/DIS 11608-2:2020)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 2: Aiguilles à deux extrémités (ISO/DIS 11608-2:2020)
Ta slovenski standard je istoveten z: prEN ISO 11608-2
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 11608-2:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11608-2:2020
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oSIST prEN ISO 11608-2:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11608-2
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2020-02-18 2020-05-12
Needle-based injection systems for medical use —
Requirements and test methods —
Part 2:
Double-ended needles
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Needle component requirements . 3
4.1.1 General. 3
4.1.2 Materials . 3
4.1.3 Tubing characteristics . 3
4.1.4 Dimensions for needle assembly . 3
4.1.5 Positioning of needle bevel inside the cartridge . 4
4.1.6 Needle points . 4
4.1.7 Freedom from defects. 5
4.1.8 Lubrication . 5
4.1.9 Cleanliness . 5
4.1.10 Limits for acidity or alkalinity . 5
4.1.11 Limits for extractable metals. 5
4.1.12 Patency of lumen . 5
4.2 Pen needle requirements . 6
4.2.1 General. 6
4.2.2 Bond between hub and needle tube . 6
4.2.3 Dislocation of measuring point at patient end . 6
4.2.4 Ease of assembly . 6
4.2.5 Sterility . 6
4.2.6 Flow rate through the needle . 7
4.3 Functional compatibility with needle-based injection systems . 7
4.3.1 General. 7
4.3.2 Needle hub assembly force . 8
4.3.3 Dose delivery . 8
4.3.4 Needle removal force . 8
4.3.5 Leakage . 8
5 Sampling . 8
6 Pre-conditioning of needles .12
6.1 Pre-conditioning in a dry-heat, cold storage and damp heat atmosphere .12
6.2 Pre-conditioning in a cyclical atmosphere .12
7 Standard atmosphere and apparatus for test .12
7.1 General .12
7.2 Standard test atmosphere .12
7.3 Test gauge .12
8 Test Methods .13
8.1 Determination of dislocation of measuring point at patient end .13
8.2 Bond between hub and needle tube .13
8.3 Ease of assembly .13
9 Functional compatibility between needles and injector systems .14
9.1 Principle .14
9.2 Apparatus and equipment .14
9.3 Sample quantity requirements .14
9.4 Test procedures .14
9.4.1 Procedure for testing the needle hub assembly force .14
9.4.2 Procedure for testing the dose accuracy .15
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
9.4.3 Procedure for testing delivery of doses .15
9.4.4 Procedure for testing needle hub torque removal .15
9.4.5 Procedure for testing leakage .15
10 Packaging .15
11 Information supplied by the manufacturer .16
11.1 General .16
11.2 Marking .16
11.2.1 General.16
11.2.2 Marking on the unit packaging .17
11.2.3 Marking on the user packaging .17
11.3 Instructions for use .18
Annex A (normative) Determination of flow rate through needle .19
Annex B (informative) Needle bonding strength test method .21
Annex C (normative) Method for preparation of extracts .22
Bibliography .23
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(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 rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.
The committee responsible for this document is ISO/TC 84 Devices for administration of medicinal
products and catheters.
This third edition cancels and replaces the second edition (ISO 11608-2:2012), which has been
technically revised.
Information about the revision history of the ISO 11608 series can be found in ISO 11608-1:20##.
A list of all parts in the ISO 11608 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
Introduction
This document covers sterile double-ended needles intended for single use in conjunction with needle-
based injection systems (e.g. pen injectors). These needles are often referred to as pen needles.
The devices described in this document are designed to be used with the devices described in
ISO 11608-1 and ISO 11608-3. ISO 11608-1 is the umbrella document. All other parts, including this
document, are used in conjunction with ISO 11608-1.
The first edition of this document introduced the concept of interchangeability and the labelling
designations “Type A” (i.e. interchangeable) and “non-Type A” for needles and container closure
systems. Since its promulgation, experience has shown that the complexity of these systems makes it
very difficult to ensure functional compatibility as defined in the different parts of this International
Standard, particularly when products are made by different manufacturers and the design is not verified
as a system. Based on this experience, it is believed that the Type A designation does not represent
adequate guidance to the user in making decisions on the compatibility of needles and container
closures with specific needle-based injection systems (NIS). As such, the labelling designation “Type A”
has been removed.
The second edition of this document addressed functional compatibility of the system through testing
in accordance with Clause 11. Flow rate was introduced as a new parameter. The sampling plans for
inspection selected for this document and outlined in 11608-1 are intended to verify the design, at a high
confidence level. The sampling plan does not replace the more general manufacturing quality systems,
including lot release, which appear in standards on quality systems, e.g. ISO 9001 or ISO 13485.
This document does not specify requirements or test methods for freedom from biological hazards
because no international agreement on the methodology and the pass/fail criteria has been reached.
Guidance on biological tests relevant to double-ended needles is given in ISO 10993-1, and it is suggested
that manufacturers take this guidance into account when evaluating products. Such evaluation should
include the effects of the sterilization process. However, national regulations might exist in some
countries, which might take precedence over the guidance in ISO 10993-1.
In some countries, national regulations exist, and their requirements might supersede or complement
this document.
Guidance on transition periods for implementing the requirements of this document is given in
ISO/TR 19244.
Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-
ended needles
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oSIST prEN ISO 11608-2:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 11608-2:2020(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 2:
Double-ended needles
1 Scope
This document specifies requirements, test methods and compatibility requirements for single-
use, double-ended, sterile needles used with needle-based injection systems (NISs) that fulfil the
specifications of ISO 11608-1.
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.
This document is not applicable to:
— needles for dental use;
— pre-filled syringe needles;
— needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 9626:2016, Stainless steel needle tubing for the manufacture of medical devices — Requirements and
test methods
1)
ISO 11608-1, Needle-based injection systems for medical use — Requirements and test methods — Part 1:
Needle-based injection systems
ISO 11608-3, Needle-based injection systems for medical use — Requirements and test methods — Part 3:
NIS containers and fluid paths
ISO 13926-2, Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11608-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
1) To be published (revises ISO 11608-1:2012). Stage at time of publication: ISO/DIS 11608-1:2020.
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
3.1
pen needle
single-use, double-ended, sterile needles with attachment system specific for needle-based injection
systems (NISs)
Note 1 to entry: See Figure 1.
Key
1 seal (3.2) l1 patient-end needle length
2 means of needle assembly attachment l2 cartridge-end needle length
3 needle hub l3 distance from the surface of the seal (3.2) to the underside of
the thread
4 needle container l4 depth of the needle hub
5 needle shield (if included) l5 distance from the underside of the thread to the surface of the
hub base
6 needle tube h1 needle hub union length
7 jointing medium (if used) d1 diameter of needle hub union
Figure 1 — Example presentation of pen needle assembly
3.2
seal
removable barrier which is intended to maintain the sterility of the needle inside the needle container
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
3.3
unit packaging
needle container, together with the seal (3.2) forming the packaging of the device, that maintains the
sterility of the needle
3.4
user packaging
what is provided to the user with one or a collection of devices, in their unit packaging (3.3), of the same
item and from the same manufacturing batch
4 Requirements
4.1 Needle component requirements
4.1.1 General
These requirements relate to the needle component included in the pen needle device.
4.1.2 Materials
The needle shall be made of tubing materials specified in ISO 9626:2016, Clause 4.
4.1.3 Tubing characteristics
The tubing characteristics used in needles shall meet the requirements of ISO 9626. If the size of
tubing is not covered in ISO 9626, the requirements for stiffness and breakage shall be adapted to
corresponding requirements for the defined sizes.
4.1.4 Dimensions for needle assembly
The dimensions of the needle assembly attachment part shall be such that the needle fits and functions
with NISs that meet the requirements specified in ISO 11608-1. Needles shall fit the test apparatus
specified in 7.3. Dimensions shall be in accordance with Table 1.
Table 1 — Dimensional requirements of needle assembly
Measurements Dimensions
mm
l specified length ±1,25
1
l 5,7 to 7,0
2
l <6,0
3
l <7,5
4
l <3,7
5
h 0 to 1,0
1
d 0 to 3,0
1
Needle manufacturers shall consider the risk of not delivering to the target tissue when setting the
specifications per Table 1, e.g. for needles of less than 6 mm in length.
Needles may be deliberately designed not to fit the test gauge described in 7.3 and not to meet the
dimensional requirements given in Table 1. In such cases, a dedicated test gauge for the specific design
shall be created in order to perform the test in 4.8. In addition, the remaining requirements, other than
those in 4.2.2, shall apply. In cases where the dimensional requirements of 4.2.2 are not met, the needle
labelling shall list the NIS(s) and accessories for which it has been designed and tested.
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
4.1.5 Positioning of needle bevel inside the cartridge
When the needle is applied to the NIS with a torque of (0,08 ± 0,02) Nm the needle bevel shall be placed
behind the septum (L > 0 mm).
6
NOTE Verification of this requirement can be based on calculations of worst case (e.g. taking into account
impact by tolerance, impact by deformation of the septum due to friction between needle and septum).
Key
L cartridge-end needle length
2
L gap between bevel and septum
6
L bottom thickness of cartridge holder
7
L thickness of septum (According to ISO 13926-2)
8
L length of bevel cut
9
NOTE LL=− LL++L
()
62,,minmin 98,,maxmax 7,max
Figure 2 — Positioning of needle bevel inside the cartridge
4.1.6 Needle points
When visually examined by normal or corrected to normal vision under magnification of ×2,5 and
illuminance of 215 ±20 lx at a reading distance of between 30 cm and 70 cm needle points shall appear
sharp and free from feather edges, burrs and hooks.
NOTE The resolution of the human eye is approximately 5µm. Based on this, burrs of around 0,05 mm can be
detected.
1 D
U==08, 2
λ
1,min
where
U is resolution;
α is angular distance;
1,min
D is circular opening of the pupil, where the light is deflected:
λ is average wavelength of the visual light.
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
The needle point at the cartridge end shall be designed so as to minimize coring and fragmentation
when penetrating the cartridge septum. Test procedure as specified in ISO 11608-3:20##, 5.2.
4.1.7 Freedom from defects
When inspected by normal or corrected-to-normal vision without magnification under an illuminance
of 215 ±20 lx at a reading distance of between 30 cm and 70 cm, the outer surface of the tubing shall be
smooth and free from defects.
4.1.8 Lubrication
The needle tube shall be lubricated at both the patient end and the cartridge end. The lubricant shall
not, under normal or corrected-to-normal vision (and illuminance of 215 ±20 lx at a reading distance of
between 30 cm and 70 cm), be visible as droplets of fluid on the outside surface of the needle tube.
4.1.9 Cleanliness
When inspected by normal or corrected-to-normal vision without magnification under an illuminance
of 300 lx to 700 lx, the surface of the needle tube (patient end and cartridge end) shall appear free from
particles and extraneous matter.
When examined under 2,5× magnification, the hub socket (fluid path surface) shall appear free from
particles and extraneous matter.
4.1.10 Limits for acidity or alkalinity
When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an
extract prepared in accordance with Annex C shall be within one unit of pH of that of the control fluid.
4.1.11 Limits for extractable metals
When tested by a recognized microanalytical method, for example by an atomic absorption method,
an extract prepared in accordance with Annex C shall, when corrected for the metals content of the
control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium
content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than
0,1 mg/l.
4.1.12 Patency of lumen
As appropriate, depending on the needle size and geometry of the needle, patency of the lumen shall be
determined by either:
a) a stainless steel stylet of the appropriate diameter selected from the diameters given in Table 2
shall pass through the needle;
b) the flow rate of water through the needle shall not be less than 80 % of an unprocessed needle
tube of equivalent outer diameter and length having a minimum inner diameter in accordance with
ISO 9626 when tested under the same pressure.
For needles tapered inside,
...
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