kSIST FprEN ISO 11608-2:2021

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO/FDIS 11608-2:2021)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 2: Kanülen mit beidseitigem Anschliff (ISO/FDIS 11608-2:2021)

Dieses Dokument legt Anforderungen und Kompatibilitätsanforderungen an sowie Prüfverfahren für sterile Kanülen mit beidseitigem Anschliff fest, die für den Einmalgebrauch in kanülenbasierten Injektionssystemen (en: needle-based injection systems, NISs) vorgesehen sind, die die Festlegungen von ISO 11608 1 erfüllen.
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.
Dieses Dokument gilt nicht für:
   Kanülen zum zahnärztlichen Gebrauch;
   Kanülen von vorgefüllten Spritzen;
   Kanülen, die für unterschiedliche Verabreichungswege (z. B. intravenös, intrathekal, intraokular) bestimmt sind.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 2: Aiguilles à deux extrémités (ISO/FDIS 11608-2:2021)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 2. del: Dvostranske igle (ISO/FDIS 11608-2:2021)

General Information

• Status: Not Published
• Public Enquiry End Date: 19-Apr-2020
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 13-Oct-2021
• Due Date: 01-Dec-2021
• Completion Date: 27-Oct-2021
• Ref Project: FprEN ISO 11608-2 - Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO/FDIS 11608-2:2021)

RELATIONS

• Revised: SIST EN ISO 11608-2:2012 - Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
• Effective Date: 01-Apr-2020

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 11608-2:2020
01-april-2020

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 2. del:

Igle (ISO/DIS 11608-2:2020)

Needle-based injection systems for medical use - Requirements and test methods - Part

2: Needles (ISO/DIS 11608-2:2020)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und

Prüfverfahren - Teil 2: Kanülen (ISO/DIS 11608-2:2020)

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -

Partie 2: Aiguilles à deux extrémités (ISO/DIS 11608-2:2020)
Ta slovenski standard je istoveten z: prEN ISO 11608-2
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 11608-2:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11608-2:2020
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oSIST prEN ISO 11608-2:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11608-2
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2020-02-18 2020-05-12
Needle-based injection systems for medical use —
Requirements and test methods —
Part 2:
Double-ended needles
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
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Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 3

4.1 Needle component requirements ........................................................................................................................................... 3

4.1.1 General...................................................................................................................................................................................... 3

4.1.2 Materials ................................................................................................................................................................................. 3

4.1.3 Tubing characteristics ................................................................................................................................................. 3

4.1.4 Dimensions for needle assembly ....................................................................................................................... 3

4.1.5 Positioning of needle bevel inside the cartridge .................................................................................. 4

4.1.6 Needle points ...................................................................................................................................................................... 4

4.1.7 Freedom from defects.................................................................................................................................................. 5

4.1.8 Lubrication ............................................................................................................................................................................ 5

4.1.9 Cleanliness ............................................................................................................................................................................ 5

4.1.10 Limits for acidity or alkalinity .............................................................................................................................. 5

4.1.11 Limits for extractable metals................................................................................................................................. 5

4.1.12 Patency of lumen ............................................................................................................................................................. 5

4.2 Pen needle requirements ............................................................................................................................................................... 6

4.2.1 General...................................................................................................................................................................................... 6

4.2.2 Bond between hub and needle tube ............................................................................................................... 6

4.2.3 Dislocation of measuring point at patient end ....................................................................................... 6

4.2.4 Ease of assembly .............................................................................................................................................................. 6

4.2.5 Sterility ..................................................................................................................................................................................... 6

4.2.6 Flow rate through the needle ................................................................................................................................ 7

4.3 Functional compatibility with needle-based injection systems ................................................................... 7

4.3.1 General...................................................................................................................................................................................... 7

4.3.2 Needle hub assembly force ..................................................................................................................................... 8

4.3.3 Dose delivery ....................................................................................................................................................................... 8

4.3.4 Needle removal force ................................................................................................................................................... 8

4.3.5 Leakage .................................................................................................................................................................................... 8

5 Sampling ........................................................................................................................................................................................................................ 8

6 Pre-conditioning of needles ...................................................................................................................................................................12

6.1 Pre-conditioning in a dry-heat, cold storage and damp heat atmosphere .......................................12

6.2 Pre-conditioning in a cyclical atmosphere ...................................................................................................................12

7 Standard atmosphere and apparatus for test .....................................................................................................................12

7.1 General ........................................................................................................................................................................................................12

7.2 Standard test atmosphere ..........................................................................................................................................................12

7.3 Test gauge .................................................................................................................................................................................................12

8 Test Methods ..........................................................................................................................................................................................................13

8.1 Determination of dislocation of measuring point at patient end .............................................................13

8.2 Bond between hub and needle tube ..................................................................................................................................13

8.3 Ease of assembly .................................................................................................................................................................................13

9 Functional compatibility between needles and injector systems ..................................................................14

9.1 Principle .....................................................................................................................................................................................................14

9.2 Apparatus and equipment .........................................................................................................................................................14

9.3 Sample quantity requirements ..............................................................................................................................................14

9.4 Test procedures ...................................................................................................................................................................................14

9.4.1 Procedure for testing the needle hub assembly force ..................................................................14

9.4.2 Procedure for testing the dose accuracy ..................................................................................................15

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oSIST prEN ISO 11608-2:2020
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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
ISO/DIS 11608-2:2020(E)
3.1
pen needle

single-use, double-ended, sterile needles with attachment system specific for needle-based injection

systems (NISs)
Note 1 to entry: See Figure 1.
Key
1 seal (3.2) l1 patient-end needle length
2 means of needle assembly attachment l2 cartridge-end needle length
3 needle hub l3 distance from the surface of the seal (3.2) to the underside of
the thread
4 needle container l4 depth of the needle hub

5 needle shield (if included) l5 distance from the underside of the thread to the surface of the

hub base
6 needle tube h1 needle hub union length
7 jointing medium (if used) d1 diameter of needle hub union
Figure 1 — Example presentation of pen needle assembly
3.2
seal

removable barrier which is intended to maintain the sterility of the needle inside the needle container

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oSIST prEN ISO 11608-2:2020
ISO/DIS 11608-2:2020(E)
3.3
unit packaging

needle container, together with the seal (3.2) forming the packaging of the device, that maintains the

sterility of the needle
3.4
user packaging

what is provided to the user with one or a collection of devices, in their unit packaging (3.3), of the same

item and from the same manufacturing batch
4 Requirements
4.1 Needle component requirements
4.1.1 General

These requirements relate to the needle component included in the pen needle device.

4.1.2 Materials

The needle shall be made of tubing materials specified in ISO 9626:2016, Clause 4.

4.1.3 Tubing characteristics

The tubing characteristics used in needles shall meet the requirements of ISO 9626. If the size of

tubing is not covered in ISO 9626, the requirements for stiffness and breakage shall be adapted to

corresponding requirements for the defined sizes.
4.1.4 Dimensions for needle assembly

The dimensions of the needle assembly attachment part shall be such that the needle fits and functions

with NISs that meet the requirements specified in ISO 11608-1. Needles shall fit the test apparatus

specified in 7.3. Dimensions shall be in accordance with Table 1.
Table 1 — Dimensional requirements of needle assembly
Measurements Dimensions
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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oSIST prEN ISO 11608-2:2020
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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,
...