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 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
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
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) .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
iii
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
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
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
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
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.
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
2 means of needle assembly attachment l cartridge-end needle length
3 needle hub l distance from the surface of the seal to the underside of the thread
4 needle container l depth of the needle hub
5 needle shield (if included) l distance from the underside of the thread to the surface of the
hub base
6 needle tube h needle hub union length
7 jointing medium (if used) d diameter of needle hub union
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
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
Q Flow rate
ρ Density of the fluid
Q Minimum flow rate
min
U Resolution of the eye
∆P Pressure difference
r Inner radius (equal to ½ of the inner diameter)
η Viscosity of the test fluid
V Dose pre-set as ≥90 % of the NIS maximum dosage (expressed as a volume, in millilitres)
high
V Dose pre-set as ≤10 % of the NIS maximum dosage (expressed as a volume, in millilitres)
low
NOTE V can be set as equal to the minimum dosage of the NIS.
low
5 Requirements
5.1 Needle tube requirements
5.1.1 General
The following requirements relate to the needle tube component included in the double-ended pen
needle device.
ISO 11608-2:2022(E)
5.1.2 Needle tubing materials
The needle tubing shall be made of tubing materials specified in ISO 9626:2016, Clause 4.
5.1.3 Tubing characteristics
The tubing characteristics used in needles shall meet the requirements of ISO 9626:2016, Clause 5.
5.2 Double-ended pen needle requirements
5.2.1 General
The following requirements relate to the double-ended pen needle device. Testing shall be performed
using samples that have been exposed to all manufacturing processes, including sterilization, if
applicable.
5.2.2 Biocompatibility
Biocompatibility of the pen needle shall be established in accordance with ISO 10993-1 (see also
ISO 11608-1:2022, Annex C).
5.2.3 Dimensions for double-ended pen needle assembly
Dimensions of the double-ended pen needle assembly shall be in accordance with Table 1 (the
dimensions are shown in Figure 1).
Table 1 — Dimensional requirements of double-ended pen needle
Measurements Dimensions
mm
l specified length ±1,25
l 5,7 to 7,0
l <6,0
l <7,5
l <3,7
h 0 to 1,0
d 0 to 3,0
Needle manufacturers shall consider the risks of not delivering to the target tissue (e.g. specified length
appropriate for the target tissue) and of the cartridge end of the double-ended pen needle assembly
interfering with delivery of the medicinal product (e.g. bevel not clearing septum, too much dead space
in cartridge) when setting the specifications in accordance with Table 1.
The dimensions of the means of attachment part of the double-ended pen needle (see Figure 1,
dimension 2) shall be such that the needle fits and functions with the NIS for which it is intended. Pen
needles shall fit the test gauge specified in 8.2.
Pen needles can be deliberately designed not to fit the test gauge described in 8.2 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 tests in Clause 9. In addition, the remaining requirements, other
than those in 5.2.3, shall apply. In cases where the dimensional requirements of 5.2.3 are not met, the
needle labelling shall list the NIS(s) and accessories for which it has been designed and tested.
ISO 11608-2:2022(E)
5.2.4 Needle points
When visually inspected by normal or corrected to normal vision under magnification of 2,5x and at
environmental lighting conditions of ≥750 lx needle points shall appear sharp and free from feather
edges, burrs and hooks.
NOTE The resolution of the human eye is approximately 5 µm. Considering a safety factor of 10, burrs
of around 0,05 mm can be detected using the inspection conditions above. Where the criteria are lower than
0,05 mm, alternate inspection conditions can be used (see Annex C).
The needle point at the cartridge end shall be designed so as to minimize coring and fragmentation
when penetrating the cartridge septum. Test according to the procedure specified in ISO 11608-3:2022,
5.2.
5.2.5 Freedom from defects
When inspected by normal or corrected-to-normal vision without magnification and at environmental
lighting conditions of ≥750 lx and from a reading distance of between 30 cm and 70 cm, the double-
ended pen needle shall meet the following requirements:
a) the outer surface of the tubing shall be smooth and free from defects;
b) lubricant shall not be visible as droplets of fluid on the outside surface of the needle tube;
c) the surface of the needle tube (patient end and cartridge end) shall appear free from particles and
extraneous matter.
5.2.6 Flow rate through the needle
5.2.6.1 Non-tapered needle flow rate
For non-tapered needles, the flow rate through the needle shall demonstrate patency of the lumen,
determined by either method a) or method b):
a) Measure the flow rate of water through the needle in accordance with Annex A to determine the
minimum flow rate through the needle, in ml/min (expressed to a tenth of a ml/min). The measured
flow rate shall be made available on request.
The flow rate measured for each gauge size 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, or shall not be less than 80 % of the minimum flow
rate as calculated based on the Extended Hagen–Poiseuille equation, presented in C.3.5, which has
the following dependency: QQ= rl,,ηρ,,ΔpC,
()
When acceptance criteria are based upon the Extended Hagen-Poiseuille equation, the validity of
the equation shall be ensured when calculating the theoretical flow rate. See C.3.5 for details about
the validity of the equation.
b) Demonstrate that a stainless steel stylet of the appropriate diameter selected from the diameters
given in Table 2 shall pass through the needle.
It is recommended to use method a) for needles with designated metric sizes below 0,30 mm and hence
no stylets are listed in Table 2 for designated metric sizes below 0,30 mm.
ISO 11608-2:2022(E)
Table 2 — Size of stylet to test patency of lumen
Outer diameter of stylet
Designated
mm
metric size of
Needle
needle
for needle of regu- for needle of for needle of extra- for needle of ultra-
Gauge
lar walled tubing thin-walled thin-walled tubing thin-walled tubing
mm
tubing
0,30 30 0,11 0,13 0,15 0,19
0,33 29 0,11 0,15 0,19 0,21
0,36 28 0,11 0,15 — —
0,40 27 0,15 0,19 — —
0,45 26 0,18 0,23 — —
0,50 25 0,18 0,23 — —
0,55 24 0,22 0,27 — —
0,60 23 0,25 0,29 0,30 —
0,70 22 0,30 0,35 0,37 —
0,80 21 0,40 0,42 0,44 —
0,90 20 0,48 0,49 0,50 —
1,10 19 0,58 0,60 0,68 —
1,20 18 0,70 0,73 0,83 —
5.2.6.2 Tapered needle flow rate
For tapered needles, the patency of lumen shall be verified by measuring the flow rate of water through
the needle in accordance with Annex A to determine the minimum flow rate through the needle, in ml/
min (expressed to a tenth of a ml/min). The measured flow rate shall be made available on request.
The flow rate measured for each gauge size shall not be less than 80 % of an unprocessed needle tube
with minimum inner diameter at both the tip and hub corresponding to their respective designations
from ISO 9626, when tested under the same pressure.
5.2.7 Bond between hub and needle tube
The union of the hub and needle tube shall withstand at least the minimum force specified in Table 3
at standard atmosphere and following preconditioning in accordance with Clause 7 in dry heat, cold
storage, damp heat and cyclical atmospheres when tested in accordance with 9.1. The minimum force
shall be based on the metric size designation of the needle. For tapered needles, the minimum force
given in Table 3 shall be determined by the outer diameter of the needle tube at the hub (D ).
out-hub
ISO 11608-2:2022(E)
Table 3 — Minimum force for bond between hub and needle tube
Designated metric size Needle gauge Minimum force
of needle
N
mm
0,18 34 11
0,20 33
0,23 32
0,25 31
0,30 30
0,33 29 22
0,36 28
0,40 27
0,45 26
0,50 25
0,55 24 34
0,60 23
0,70 22 40
0,80 21 44
0,90 20 54
1,10 19 69
1,20 18
NOTE Table adapted from ISO 7864:2016, Table 2, with gauge from
9626:2016, Table 1.
5.2.8 Dislocation of measuring point at patient end
Dislocation of the cannula point (d ) at the patient end shall be in accordance with:
max
dl=×00,,70+ 3
max 1
where
d is maximum allowable dislocation, expressed in millimetres;
max
l is patient-end needle length (see Figure 1), expressed in millimetres.
when tested in accordance with 9.2.
5.2.9 Ease of assembly
Attachment of the needle to the NIS shall be possible without removing the needle from its opened unit
packaging, when tested in accordance with 9.3.
5.2.10 Sterility
The needle in its unit packaging shall have been subjected to a validated sterilization process, e.g. in
accordance with ISO 11135 or ISO 11137-1.
ISO 11608-2:2022(E)
5.2.11 Pyrogenicity
The pen needle shall be non-pyrogenic, demonstrated by fulfilling the following requirements for
endotoxin-mediated pyrogenicity and material-mediated pyrogenicity:
a) the pen needle device shall not exceed the lesser of 0,5 EU/ml (endotoxin units) or 20 EU per device
when tested, for example, in accordance with relevant pharmacopeia such as US Pharmacopeia
<161>;
b) the pen needle device shall conform to ISO 10993-11 for material-mediated pyrogenicity.
5.3 Functional compatibility with NISs
5.3.1 General
When the labelling claims that the needle is compatible with a NIS, the following functional compatibility
requirements shall be fulfilled:
a) dose delivery in accordance with 5.3.2 to confirm integrity of a clinically relevant fluid pathway;
b) needle removal torque as specified in 5.3.3.
when tested in accordance with the test methods for functional compatibility provided in 9.4.
Bracketing and matrixing of needle sizes, flow rates or other parameters may be applied, if justified.
NOTE 1 Bracketing and matrixing is typically only appropriate within a given needle manufacturer, with
consideration of the geometry of the needle hub.
NOTE 2 Dose accuracy of the combination NIS, cartridge and needle is mainly driven by 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 which is needed to deliver the entire volume but not directly to the precision of the dosage.
Additionally, a prescribed holding time can 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.
5.3.2 Dose delivery
5.3.2.1 General
The needle and the NIS shall deliver the doses set verified by either
a) dose accuracy as specified in 5.3.2.2, or
b) confirmation of dose delivery as specified in 5.3.2.3.
The sample quantity requirements specified in 9.4.1 shall apply.
5.3.2.2 Dose accuracy
When the dose accuracy testing specified in 9.4.2.2 is selected for verification of dose delivery, the
accuracy requirements in ISO 11608-1:2022, 7.4.2, shall apply.
5.3.2.3 Confirmation of dose delivery
When the qualitative confirmation of dose delivery approach is selected for verification of dose delivery,
the following shall apply:
a) When tested in accordance with the method specified in 9.4.2.3, fluid shall be expelled from the
NIS and confirmed visually.
ISO 11608-2:2022(E)
b) When tested in accordance with the method specified in 9.4.2.3, the needle when detached from
the NIS following expelling a dose shall not have visible fluid present at the base of the non-patient
end of the cannula (see intersection of l and h in Figure 1).
2 1
c) The needle bevel shall be positioned behind the septum (l > 0 mm) inside the cartridge when the
pen needle is applied to the NIS with a torque of (0,07 ± 0,01) Nm. An example for positioning of the
needle bevel inside the cartridge is illustrated in Figure 2. For calculations, see Annex C.
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). The calculations may differ for alternative designs, including other means of cartridge
support in the cartridge holder (e.g. cartridge shoulder).
Key
l cartridge-end needle length
l gap between bevel and septum
l bottom thickness of cartridge holder
l thickness of septum
l length of bevel cut
h needle hub union length
As there can be additional influences on dimensions, such as due to crimping processes, it is recommended to
measure the dimension l and l for the NIS that the manufacturer intends to claim conformance to in order to
7 8
determine l .
Figure 2 — Example of positioning of needle bevel inside the cartridge
5.3.3 Needle removal torque
The needle hub peak removal torque shall be determined for the combination of the needle and the NIS
with which compatibility is sought. Testing shall be performed in accordance with 9.4.3.
The needle hub peak removal torque shall be less than 0,100 Nm. If the needle has no thread, applicable
assembly and disassembly testing shall be adapted to the corresponding requirements:
a) if three or more needles result in a peak (removal) torque of 0,100 Nm or more, the test is rejected;
b) if zero, one or two needles result in a peak (removal) torque of 0,100 Nm or more, the test results
are accepted.
ISO 11608-2:2022(E)
6 Sampling
Table 4 summarizes test requirements for double-ended pen needles devices intended to be used with
NISs.
Table 5 summarizes test requirements when demonstrating functional compatibility between double-
ended pen needles and NISs.
Each test case can have more than one characteristic (e.g. needle removal force plus others) that needs to
be tested. The sample size here is for each characteristic to be tested, although multiple characteristics
can be tested on the same set of samples, and potentially at the same time.
Other sample sizes may be chosen. However, if smaller than the recommended sample size, it shall be
justified that the sample size is appropriate for the risk associated with the characteristic.
Either dose accuracy or confirmation of dose delivery methods may be used to satisfy the dose delivery
requirement (5.3.2).
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