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 (en: needle-based injection systems, NISs) 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)

General Information

Status
Published
Public Enquiry End Date
19-Apr-2020
Publication Date
15-Jun-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
20-May-2022
Due Date
25-Jul-2022
Completion Date
16-Jun-2022

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 11608-2:2022
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 11608-2:2022
EN ISO 11608-2:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 11608-2:2022
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
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

iii
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
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

© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
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;
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
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.
© ISO 2022 – All rights reserved
---------------------- Page: 12 ----------------------
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
© ISO 2022 – All rights reserved
---------------------- Page: 13 ----------------------
SIST EN ISO 11608-2:2022
---------------------- Page: 14 ----------------------
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.
© ISO 2022 – All rights reserved
---------------------- Page: 15 ----------------------
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
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 2022 – All rights reserved
---------------------- Page: 16 ----------------------
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
Angular distance
1,min
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.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 11608-2:2020
---------------------- Page: 2 ----------------------
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
ISO/CEN PARALLEL PROCESSING
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.
ISO/DIS 11608-2:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
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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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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

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
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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
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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
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 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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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).

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
L gap between bevel and septum
L bottom thickness of cartridge holder
L thickness of septum (According to ISO 13926-2)
L length of bevel cut
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
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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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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