SIST EN ISO 11608-2:2012

SLOVENSKI STANDARD
SIST EN ISO 11608-2:2012
01-september-2012
1DGRPHãþD
SIST EN ISO 11608-2:2001
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 2. del:
Igle (ISO 11608-2:2012)
Needle-based injection systems for medical use - Requirements and test methods - Part
2: Needles (ISO 11608-2:2012)
Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 2: Nadeln (ISO 11608-2:2012)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 2: Aiguilles (ISO 11608-2:2012)
Ta slovenski standard je istoveten z: EN ISO 11608-2:2012
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11608-2:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11608-2:2012

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SIST EN ISO 11608-2:2012


EUROPEAN STANDARD
EN ISO 11608-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2012
ICS 11.040.25 Supersedes EN ISO 11608-2:2000
English Version
Needle-based injection systems for medical use - Requirements
and test methods - Part 2: Needles (ISO 11608-2:2012)
Systèmes d'injection à aiguille pour usage médical - Nadelbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 2: Aiguilles (ISO Verwendung - Anforderungen und Prüfverfahren - Teil 2:
11608-2:2012) Nadeln (ISO 11608-2:2012)
This European Standard was approved by CEN on 31 March 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-2:2012: E
worldwide for CEN national Members.

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SIST EN ISO 11608-2:2012
EN ISO 11608-2:2012 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 11608-2:2012
EN ISO 11608-2:2012 (E)
Foreword
This document (EN ISO 11608-2:2012) has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and intravascular catheters" in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2012, and conflicting national standards shall be withdrawn at
the latest by October 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11608-2:2000.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11608-2:2012 has been approved by CEN as a EN ISO 11608-2:2012 without any
modification.

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SIST EN ISO 11608-2:2012

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SIST EN ISO 11608-2:2012
INTERNATIONAL ISO
STANDARD 11608-2
Second edition
2012-04-01
Needle-based injection systems for medical
use — Requirements and test methods —
Part 2:
Needles
Systèmes d’injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 2: Aiguilles
Reference number
ISO 11608-2:2012(E)
©
ISO 2012

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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Materials . 3
4.2 Dimensions . 3
4.3 Determination of flow rate through the needle. 3
4.4 Bond between hub and needle tube . 3
4.5 Needle points . 4
4.6 Freedom from defects . 4
4.7 Lubrication . 4
4.8 Dislocation of measuring point at patient end . 4
4.9 Determination of functional compatibility with needle-based injection systems . 4
4.10 Ease of assembly and disassembly . 4
4.11 Sterility . 4
5 Sampling . 4
6 Pre-conditioning of needles . 5
6.1 Pre-conditioning in a dry-heat atmosphere . 5
6.2 Pre-conditioning in a cold-storage atmosphere . 5
6.3 Pre-conditioning in a cyclical atmosphere . 5
7 Standard atmosphere and apparatus for tests . 6
7.1 General . 6
7.2 Standard test atmosphere . 6
7.3 Test gauge . 6
8 Determination of dislocation of measuring point at patient end . 7
9 Bond between hub and needle tube . 8
10 Packaging . 8
11 Test method for validating the compatibility of needles and injector systems . 8
11.1 Principle . 8
11.2 Apparatus and equipment . 9
11.3 Sample quantity requirements . 9
11.4 Procedure . 9
11.5 Acceptance criteria . 11
11.6 Test report .12
12 Information supplied by the manufacturer .12
12.1 General .12
12.2 Marking .12
12.3 Instructions for use .14
Annex A (normative) Determination of flow rate through needle .15
Bibliography .17
© ISO 2012 – All rights reserved iii

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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11608-2 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.
This second edition cancels and replaces the first edition (ISO 11608-2:2000), which has been technically revised.
ISO 11608 consists of the following parts, under the general title Needle-based injection systems for medical
use — Requirements and test methods:
— Part 1: Needle-based injection systems
— Part 2: Needles
— Part 3: Finished containers
— Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
— Part 5: Automated functions
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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
Introduction
This part of ISO 11608 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 part of ISO 11608 are designed to be used with the devices described in
ISO 11608-1 and ISO 11608-3.
The first edition of this part of ISO 11608 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.
This second edition of ISO 11608-2 addresses functional compatibility of the system through testing in
accordance with Clause 11. Flow rate is introduced as a new parameter. The sampling plans for inspection
selected for this part of ISO 11608 are intended to verify, at a high confidence level, the manufacturer’s ability
to manufacture one “lot” of needles that conforms to the critical product attributes. The sampling plans for
inspection do not replace the more general manufacturing quality systems that appear in standards on quality
systems, for example ISO 9000.
This part of ISO 11608 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 part
of ISO 11608.
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SIST EN ISO 11608-2:2012

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SIST EN ISO 11608-2:2012
INTERNATIONAL STANDARD ISO 11608-2:2012(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 2:
Needles
1 Scope
This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles
for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.
It is not applicable to:
— needles for dental use;
— pre-filled syringe needles;
— needles pre-assembled by the manufacturer;
— needles not requiring assembly or attachment to the NIS.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices
ISO 11608-1, Needle-based injection systems for medical use — Requirements and test methods — Part 1:
Needle-based injection systems
IEC 60068-2-30:2005, Environmental testing — Part 2-30: Tests — Test Db: Damp heat, cyclic (12 h + 12 h cycle)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
NIS
needle-based injection system
system intended for parenteral administration by injection of medicinal products using a multi-dose or single-
dose container
See Figure 1.
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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
1
l4
h1
3
4
5
6
l2
2
l1
l5
l3
7
Key
1 seal
2 means of needle assembly attachment
3 needle hub
4 needle container
5 needle shield (not required)
6 needle tube
7 jointing medium (if used)
NOTE The needle container may serve as a needle shield.
Figure 1 — Example presentation of needle assembly for a NIS
3.2
seal
removable barrier which is intended to maintain the sterility of the needle inside the needle container
3.3
unit packaging
needle container, together with the seal 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, of the same item and
from the same manufacturing batch
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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
4 Requirements
4.1 Materials
The needle shall be made of tubing materials specified in ISO 9626 or ISO 15510. The requirements in
ISO 9626 apply.
4.2 Dimensions
4.2.1 General
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 11608-1.
The tubing characteristics used in needles shall meet the requirements of ISO 9626. If the tubing is not covered
in that International Standard, the requirements for stiffness and breakage shall be adapted to corresponding
requirements for the defined sizes.
4.2.2 Dimensions for needles
Needles shall fit the test apparatus specified in 7.3. Dimensions shall be in accordance with Table 1.
Table 1 — Dimensional requirements of needle assembly
Measurements Dimensions
mm
l specified length ±1,25
1
l 5,7 to 7,0
2
l <6,0
3
l <7,5
4
l <3,7
5
h 0 to 1,0
1
d 0 to 3,0
1
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 labelling shall state that the needle be
used exclusively with the NIS designed for, and tested with, this needle.
4.3 Determination of flow rate through the needle
The needle shall be tested in accordance with Annex A to determine the flow rate through the needle, in
millilitres per minute. In addition to complying with the labelling requirements of Clause 12, the flow rate shall
be made available on request.
NOTE The flow rate parameter is not a strict requirement of Clause 12, but may be of interest for a NIS manufacturer or
other party. Flow rate is an important factor in the overall NIS system performance, as is the injection force and injection time.
4.4 Bond between hub and needle tube
The union of the hub and needle tube shall not break when tested in accordance with Clause 9.
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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
4.5 Needle points
When examined under a magnification of ×2,5, needle points shall appear sharp and free from feather edges,
burrs and hooks.
The needle point at the cartridge end shall be designed so as to minimize coring and fragmentation when
penetrating the cartridge septum.
4.6 Freedom from defects
The needle tube shall fulfil the requirements of ISO 7864:1993, 11.3.
4.7 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, be visible as droplets of fluid on the outside surface of the needle tube.
4.8 Dislocation of measuring point at patient end
Dislocation of the cannula point at the patient end shall be in accordance with Table 2 when tested in accordance
with Clause 8.
Table 2 — Maximum allowable dislocation at patient end
Patient-end needle length Maximum allowable dislocation
l d
1 max
mm mm
8 0,9
12 1,1
16 1,4
Others 0,07 × l + 0,3
1
4.9 Determination of functional compatibility with needle-based injection systems
Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11. Functional
requirements are also defined in other parts of ISO 11608 and in the instructions for use of the NIS.
4.10 Ease of assembly and disassembly
Attachment of the needle shall be possible without removing the needle from its opened unit packaging.
Compliance is checked according to the requirements of Clause 11.
4.11 Sterility
The needle in its unit packaging shall have been subjected to a validated sterilization process.
5 Sampling
Select 350 needles.
Use 50 needles for the first sample test cycle (sample 1). If two or more needles do not meet the test criteria, the
needle type in question is rejected. However, the needle type cannot be accepted based on this first sample alone.
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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
If the needle type is not rejected on the first sample test cycle, perform a test cycle incorporating a second
sample of 50 needles (sample 2). If three or more needles fail the test, the batch shall be rejected. If no needles
fail the test, the needle type is accepted.
If two needles for sample 1 or three needles for sample 2 fail the test, select a third sample of 50 needles and
continue down the table, using the acceptance and rejection test criteria shown in Table 3.
Table 3 — Sampling plan and acceptance/rejection criteria
Sample number Sample size Cumulative Acceptance Rejection
a a
sample size criteria criteria
b
1 50 50 N/A 2
2 50 100 0 3
3 50 150 0 3
4 50 200 1 4
5 50 250 2 4
6 50 300 3 5
7 50 350 4 5
NOTE  The numbers in the table are derived from the original version in ISO 2859-1.
a
Number of needles.
b
Acceptance not permitted at this stage.
6 Pre-conditioning of needles
6.1 Pre-conditioning in a dry-heat atmosphere
Place the needle within its unit packaging in a test chamber for at least 96 h in the following atmosphere:
— temperature: (70 ± 2) °C;
— relative humidity: (50 ± 10) %RH.
6.2 Pre-conditioning in a cold-storage atmosphere
Place the needle within its unit packaging in a test chamber for at least 96 h in the following atmosphere:
— temperature: (−40 ± 3) °C.
6.3 Pre-conditioning in a cyclical atmosphere
Place the needle within its unit packaging in a test chamber. Carry out conditioning in accordance with
IEC 60068-2-30 as follows:
— variant 1 [see IEC 60068-2-30:2005, Figure 2 a)];
— lower temperature: (25 ± 3) °C (no humidity requirement);
— upper temperature: (55 ± 2) °C;
— six cycles.
NOTE The relevant clauses of IEC 60068-2-30:2005 are Clause 4 (testing chamber), Clause 7 (conditioning) and
Clause 9 (recovery).
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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
7 Standard atmosphere and apparatus for tests
7.1 General
Any suitable test system can be used provided that the required accuracy (calibration) and precision (Gauge
R&R) can be obtained. The repeatability and reproducibility (Gauge R&R) of the test apparatus shall not
exceed 20 % of the allowed tolerance range for any given measurement. For destructive test measurements,
the Gauge R&R shall not exceed 30 % of the allowed tolerance range. At a minimum, the Gauge R&R should
cover ±2 standard deviations (thereby covering approximately 95 % of the variation).
EXAMPLE A measurement system with a measurement specification limit of ±0,01 ml (range of 0,02 ml) comes out of
the Gauge R&R with a Gauge R&R to tolerance range ratio of 20 %, which means that the Gauge R&R (four standard
uncertainties) equals 0,02 ml/5 ml = 0,004 ml. The uncertainty of the measurement is ±2 standard deviations (see ISO
Guide 98-1), which equals 0,002 ml.
Some of the requirements in this part of ISO 11608 only have one-sided limits, in which case the Gauge R&R
should only be used to find the R&R standard deviation. The measurement uncertainties are calculated as
twice the Gauge R&R standard deviations.
For such measurements in this part of ISO 11608, the maximum measurement uncertainty requirements are:
— 0,01 mm for dimensions;
— 0,001 Nm for torques;
— 0,001 bar for pressures;
— 0,25 s for time;
— 0,001 g for mass.
All doses, V, delivered are recorded gravimetrically, m (expressed in grams). These recordings are converted
to volumes, m, by using the density, ρ, (expressed in grams per millilitre) for the test liquid at environmental
conditions. The following equation can be used to convert gravimetric measurements to volumetric:
m
V =
meas
ρ
7.2 Standard test atmosphere
Unless otherwise specified, measurements shall be performed in the following atmosphere:
— temperature from 18 °C to 28 °C,
— relative humidity from 25 %RH to 75 %RH,
after having been subjected to storage for at least 4 h in this atmosphere.
7.3 Test gauge
The test gauge shall be made out of hardened steel, e.g. W1.803. The dimensions shall be in accordance
with Figure 2.
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SIST EN ISO 11608-2:2012
ISO 11608-2:2012(E)
Dimensions in millimetres


a
An adjacent part of the mandrel shall replace face A and be adapted to the test tool.
Figure 2 — Test gauge for needles
Needles may be deliberately designed not to fit the test gauge shown in Figure 2 and not to meet the dimensional
requirements given in Table 1.
8 Determination of dislocation of measuring point at patient end
Select samples in accordance with Clause 5.
Tighten the needle to the test gauge (see Figure 2) with a torque of (0,07 ± 0,01) Nm.
Place the test gauge upon a “V-block” that is affixed to the cross-slide of an optical comparator.
Align the top edge of the cylindrical part of the test gauge outer diameter with the x-axis of the comparator.
Move the “V-block” upwards by half the outer diameter of the test gauge. This will align the test gauge centre
line with the x-axis of the comparator.
Rotate the test gauge by hand and record the maximum dislocation (positive or negative) of the centre of the
lumen at the level of the measuring point shown in Figure 3 relative to the x-axis of the comparator.
NOTE Methods other than the non-contact method are acceptable to determine dislocation.
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SIST EN ISO 11608-2:2012
ISO 11608
...