SIST EN ISO 11608-1:2001

Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods (ISO 11608-1:2000)

Specifies accuracy, performance and interchangeability dimensions of pen- injectors for use with insulin and other drugs

Pen-Injektoren zur medizinischen Anwendung - Teil 1: Pen-Injektoren - Anforderungen und Prüfverfahren (ISO 11608- 1:2000)

Diese Internationale Norm legt Anforderungen und Prüfverfahren für Pen-Injektoren fest, die zur Verwendung mit Kanülen und austauschbaren oder nichtaustauschbaren mit vorgefüllten Karpulen bestimmt sind. Pen-Injektoren, die nicht elektrisch angetrieben werden, abet mit elektronischen Bauteilen bestückt sind, werden durch diese Norm erfaßt. Hochdruck-Injektoren und elektrisch angetriebene Injektoren werden nicht durch die Norm erfaßt.

Stylos-injecteurs a usage médical - Partie 1: Stylos-injecteurs -Exigences et méthodes d'essai (ISO 11608-1:2000)

La présente partie de l'ISO 11608 spécifie les exigences et les méthodes d'essai des stylos-injecteu rs destinés à être utilisés avec des aiguilles et des cartouches préremplies remplaçables ou non remplaçables. La présente partie de l'ISO 11608 est également applicable aux stylos- i njecteu rs qui ne sont pas actionnés électriquement mais qui sont pourvus de composants électroniques. La présente partie de l'ISO 11608 ne s'applique pas aux injecteurs haute pression ni aux injecteurs actionnés électriquement.

Peresa za injiciranje za uporabo v medicini - 1. del: Peresa za injiciranje - Zahteve in preskusne metode (ISO 11608-1:2000)

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-2001
• Withdrawal Date: 01-Aug-2012
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Aug-2012
• Due Date: 24-Aug-2012
• Completion Date: 02-Aug-2012
• Ref Project: EN ISO 11608-1:2000 - Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods (ISO 11608-1:2000)

Relations

• Child: SIST EN ISO 11608-2:2001 - Pen-injectors for medical use - Part 2: Needles - Requirements and test methods (ISO 11608-2:2000)
• Effective Date: 22-Dec-2008
• Child: SIST EN ISO 11608-3:2001 - Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods (ISO 11608-3:2000)
• Effective Date: 22-Dec-2008
• Replaced By: SIST EN ISO 11608-1:2012 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012)
• Effective Date: 01-Sep-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11608-1:2001
01-november-2001
Peresa za injiciranje za uporabo v medicini - 1. del: Peresa za injiciranje - Zahteve
in preskusne metode (ISO 11608-1:2000)
Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods
(ISO 11608-1:2000)
Pen-Injektoren zur medizinischen Anwendung - Teil 1: Pen-Injektoren - Anforderungen
und Prüfverfahren (ISO 11608- 1:2000)
Stylos-injecteurs a usage médical - Partie 1: Stylos-injecteurs -Exigences et méthodes
d'essai (ISO 11608-1:2000)
Ta slovenski standard je istoveten z: EN ISO 11608-1:2000
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11608-1:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11608-1:2001

---------------------- Page: 2 ----------------------

SIST EN ISO 11608-1:2001

---------------------- Page: 3 ----------------------

SIST EN ISO 11608-1:2001

---------------------- Page: 4 ----------------------

SIST EN ISO 11608-1:2001

---------------------- Page: 5 ----------------------

SIST EN ISO 11608-1:2001

---------------------- Page: 6 ----------------------

SIST EN ISO 11608-1:2001
INTERNATIONAL ISO
STANDARD 11608-1
First edition
2000-12-15
Pen-injectors for medical use —
Part 1:
Pen-injectors — Requirements and test
methods
Stylos-injecteurs à usage médical —
Partie 1: Stylos-injecteurs — Exigences et méthodes d'essai
Reference number
ISO 11608-1:2000(E)
©
ISO 2000

---------------------- Page: 7 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not
be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this
file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this
area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters
were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event
that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2000
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 [e-mail]
Web www.iso.ch
Printed in Switzerland
ii © ISO 2000 – All rights reserved

---------------------- Page: 8 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Symbols and abbreviations.3
5 General requirements.4
6 Test conditions .5
6.1 Standard atmosphere.5
6.2 Cool atmosphere.5
6.3 Hot atmosphere.5
7 Preconditioning of pen-injectors .6
7.1 Preconditioning in dry heat atmosphere.6
7.2 Preconditioning in cold storage atmosphere .6
7.3 Preconditioning in cyclical atmosphere.6
7.4 Preconditioning by free fall .6
7.5 Preconditioning by vibration for pen-injectors with electronic components .7
8 Reagent and apparatus .7
9 Determination of dose accuracy .7
9.1 Dose accuracy.7
9.2 Dose accuracy requirements.12
10 Freedom from defects .14
10.1 Defects after being subjected to cyclical preconditioning.14
10.2 Freedom from defects after being subjected to vibration.14
10.3 Freedom from defects after being subjected to free fall .14
11 Determination of electromagnetic compatibility .14
11.1 Electromagnetic compatibility (EMC) .14
11.2 Electrostatic discharge .15
11.3 Radiated radio frequency (RF) fields.15
12 Visual inspection .15
13 Functional inspection.16
13.1 Replaceable cartridge .16
13.2 Nonreplaceable cartridge.16
13.3 Accuracy.16
14 Test report .16
15 Information supplied by the manufacturer .16
15.1 General.16
15.2 Marking .17
15.3 Instructions for use .17
Annex A (informative) Two-sided tolerance limit factors (k) .19
Bibliography.25
© ISO 2000 – All rights reserved iii

---------------------- Page: 9 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(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 3.
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 part of ISO 11608 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 11608-1 was prepared by Technical Committee ISO/TC 84, Medical devices for
injections.
ISO 11608 consists of the following parts, under the general title Pen-injectors for medical use:
� Part 1: Pen-injectors — Requirements and test methods
� Part 2: Needles — Requirements and test methods
� Part 3: Finished cartridges — Requirements and test methods
Annex A of this part of ISO 11608 is for information only.
iv © ISO 2000 – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
Introduction
This part of ISO 11608 covers pen-injectors primarily intended for human use. It provides performance
requirements regarding essential aspects, so that variations of design are not unnecessarily restricted.
The devices described in this part of ISO 11608 are designed to be used with devices described in ISO 11608-2
and ISO 11608-3.
It is recognized that interchangeability of the components (pen-injector, needle and cartridge) is desirable for some
medicinal products and to be avoided for other medicinal products, and that future design may change the current
concepts. Therefore, ISO 11608-2 and ISO 11608-3 encourage interchangeability by establishing certain specific
requirements for interchangeable needles (Type A) and interchangeable cartridges (Type A) respectively.
Performance requirements are imposed on both Type A (interchangeable) and non-Type A needles and cartridges.
Additional dimensional requirements are imposed on Type A needles and cartridges and hereby indirectly on pen-
injectors intended for either Type A needles and/or Type A cartridges.
Information as to whether the components are interchangeable (Type A) or not should be given on the unit
container.
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 pen-injectors 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, e.g. the ISO 9000 series.
Materials to be used for the construction are not specified, as their selection to some extent will depend upon the
design, the intended use and the process of manufacture by individual manufacturers. All materials should be
resistant to the medicinal product intended to be injected with the pen-injector.
In some countries national regulations exist, and their requirements may supersede or complement this part of
ISO 11608.
© ISO 2000 – All rights reserved v

---------------------- Page: 11 ----------------------

SIST EN ISO 11608-1:2001

---------------------- Page: 12 ----------------------

SIST EN ISO 11608-1:2001
INTERNATIONAL STANDARD ISO 11608-1:2000(E)
Pen-injectors for medical use —
Part 1:
Pen-injectors — Requirements and test methods
1 Scope
This part of ISO 11608 specifies requirements and test methods for pen-injectors intended to be used with needles
and with replaceable or non-replaceable prefilled cartridges.
This part of ISO 11608 is also applicable to pen-injectors which are not electrically driven, but are equipped with
electronic components.
This part of ISO 11608 is not applicable to high-pressure injectors and electrically driven injectors.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 11608. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 11608 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 11608-2:2000, Pen-injectors for medical use — Part 2: Needles — Requirements and test methods.
ISO 11608-3:2000, Pen-injectors for medical use — Part 3: Finished cartridges — Requirements and test methods.
IEC 60068-2-6:1995, Environmental testing — Part 2: Tests. Test Fc: Vibration (sinusoidal).
IEC 60068-2-6:1995, Corr. 1.
IEC 60068-2-30:1980, Environmental testing — Part 2: Tests. Test Db and guidance: Damp heat, cyclic (12 + 12-
hour cycle).
IEC 60068-2-30, Amendment No. 1:1985.
IEC 61000-4-2:1999, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement techniques —
Electrostatic discharge immunity test.
IEC 61000-4-3:1998, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques —
Radiated, radio-frequency, electromagnetic field immunity test.
3 Terms and definitions
For the purposes of this part of ISO 11608, the following terms and definitions apply.
© ISO 2000 – All rights reserved 1

---------------------- Page: 13 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
The nomenclature of some components of pen-injectors is illustrated in Figure 1.
3.1
pen-injector
medical device intended for parenteral administration by injection of medicinal products from a multidose cartridge
NOTE The doses may be pre-set by manufacturer or user.
3.2
connector
mechanical arrangement allowing the connection between the needle and the cartridge
3.3
cartridge
primary container for the medicinal product
3.4
injection mechanism
mechanism which performs the parenteral injection of the pre-set dose
3.5
release mechanism
mechanism which initiates the parenteral injection of the pre-set dose
3.6
injection stroke
that portion of a parenteral injection involving movement of the injection mechanism following initiation by the
release mechanism
NOTE It does not include the subsequent relaxation of the system components required for the complete injection of the
pre-set dose.
3.7
mechanism holder
part of the body of the injector containing the injection mechanisms
3.8
selector
mechanism which allows pre-setting of a dose
3.9
increment
smallest possible difference to be selected between two dose amounts
3.10
indicator
means by which the amount of pre-set dose is shown
3.11
residual scale
graduated scale which indicates the remainder of medicinal product in the cartridge
3.12
dose accuracy
accuracy with which the pen-injector delivers a pre-set dose of medicinal products
3.13
cap
part of the pen-injector intended to protect the system
2 © ISO 2000 – All rights reserved

---------------------- Page: 14 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
3.14
pre-setting
procedure by which individual amounts of medicinal product can be selected for injection by the user
3.15
unit container
package intended for customer use
3.16
Type A
classification of needles and cartridges for pen-injectors which fulfil certain specific requirements providing
interchangeability
3.17
non-Type A
classification of needles and cartridges which are not classified as Type A
Key
1Cap
2 Injection system
3 Connector
4 Residual scale
5 Window
6 Cartridge holder
7 Mechanism holder
8 Release mechanism
Figure 1 — Schematic presentation of a pen-injector
4 Symbols and abbreviations
V One of the three pre-set doses (expressed as a volume, in millilitres) used in determining the dose
set
accuracy for a given pen-injector. V is defined as one of the following:
set
a) minimum dose (V = V ) (specified in the instructions for use);
set min
b) maximum dose (V = V ) (specified in the instructions for use);
set max
c) midpoint dose (V = V ), where V is defined as the injector setting closest to (V + V )/2.
set mid mid min max
NOTE Recommended doses as specified in the instruction for use may differ from those doses that can be set.
V The volumetric measurement value for a given V
meas set
G The gravimetric measurement value for a given V
meas set
© ISO 2000 – All rights reserved 3

---------------------- Page: 15 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
� Density, expressed in grams per millilitre
p Probability content
Y Number of pens required for a given test
R Number of replicates required for a given test. A replicate is a random sequence of V , V , and V
min mid max.
There are six possible replicates.
n Number of measurements (V ) to be made for each V
meas set
x The sample mean; when based on a random sample, an estimate of the true mean:
xV� /n
� meas
s The sample standard deviation; when based on a random sample, an estimate of the true standard
deviation:
1/ 2
��
sV��()x ² /(n� 1)
meas
�
��
k Tolerance Limit Factor, determined from the confidence level (95 %), probability content (p)and the
number of accuracy measurements (n) conducted at each dose setting
� Absolute error (millilitres) used to define the upper and lower specification limits for a pre-set dose in
absolute terms
� Relative error (%) used to define the upper and lower specification limits for a pre-set dose in relative
terms
TP The transition point volume (millilitres) at which the definition of the upper and lower specification limits for
V changes from absolute terms to relative terms:
set
TP��(100 ��)/
U Upper specification limit for a given V
set
L Lower specification limit for a given V
set
5 General requirements
When the pen-injector is ready for injection, the cartridge holder shall allow visibility of the deliverable volume. It
shall be possible to determine whether sufficient medicinal product remains in order to administer the maximum
pre-settable dose.
The pen-injector shall be designed such that it is able to deliver the labelled volume from the cartridge for which it is
designed.
The pen-injector shall be designed such that the last dose delivered from a cartridge satisfies requirements for
dose accuracy.
The pen-injector shall indicate the pre-set dose.
The pen-injector shall indicate, at least by visual means, that it is ready for injection. There shall be an indication of
the pre-setting procedure by tactile or audible means, or both.
4 © ISO 2000 – All rights reserved

---------------------- Page: 16 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
The state of the pen-injector, when ready to deliver a dose, shall be different to its state when the dose has been
delivered. The difference shall be visible.
The pen-injector shall indicate, by visual, audible or tactile means or any combination of these, that the injection
stroke has been completed.
If the pen-injector is designed for variable doses, it shall be so designed that it is impossible to deliver a second
dose after delivery of the first dose without a second pre-setting.
The pen-injector shall be so designed that it:
� does not allow a larger dose to be pre-set than is left in the cartridge; or
� does not allow dose delivery if the pre-set amount exceeds the amount of medicinal product left in the
cartridge; or
� indicates the amount of medicinal product delivered; or
� indicates the amount of medicinal product not delivered of the pre-set dose.
The pen-injector shall be designed to function with a needle fulfilling the specifications of ISO 11608-2.
If the pen-injector is designed to function with a single-compartment cartridge, it shall be designed to function with a
cartridge fulfilling the specifications of ISO 11608-3.
6 Test conditions
6.1 Standard atmosphere
Unless otherwise specified, measurements shall be performed in the following atmosphere:
� temperature: from 18 �Cto28 �C;
� relative humidity: from 25 % RH to 75 % RH;
after having been subjected to storage for at least 4 h in this atmosphere.
6.2 Cool atmosphere
The assembled pen-injector with the cartridge and needle is placed in a test chamber for at least 4 h in the
following cool atmosphere:
� temperature: (5� 3) �C.
6.3 Hot atmosphere
The assembled pen-injector with the cartridge and needle is placed in a test chamber for at least 4 h in the
following hot atmosphere:
� temperature: (40 � 2) �C;
� relative humidity: (50 � 10) % RH.
© ISO 2000 – All rights reserved 5

---------------------- Page: 17 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
7 Preconditioning of pen-injectors
7.1 Preconditioning in dry heat atmosphere
The pen-injector without the cartridge and needle is placed in a test chamber for at least 96 h in the following hot
atmosphere:
� temperature: (70 � 2) �C;
� relative humidity: (50 � 10) % RH.
7.2 Preconditioning in cold storage atmosphere
The pen-injector without the cartridge and needle is placed in a test chamber for at least 96 h in the following cold
atmosphere:
� temperature: (�40 � 3)�C.
7.3 Preconditioning in cyclical atmosphere
The pen-injector with the cartridge and without the needle is placed in a test chamber. Conditioning in accordance
with IEC 60068-2-30 is carried out as follows:
� variant 1 (see IEC 60068-2-30, Figure 2a);
� upper temperature: (55 � 2) �C; and
� 6cycles.
NOTE The relevant clauses of IEC 60068-2-30:1980 are: clauses 3, 6 and 8.
7.4 Preconditioning by free fall
Prepare the pen-injector according to the instructions for use with a new cartridge and proceed as follows:
a) Pen-injectors with replaceable cartridges
1) Expel the air.
2) Take off the needle and put on the cap.
3) Drop each pen-injector three times by free fall from a height of 1 000 mm onto the test surface (see 8.3),
o
once horizontally and twice vertically, the pen-injector being rotated 180 between the two vertical drops.
Care shall be taken that the pen-injector is released in a non-turbulent way.
4) If a cartridge breaks such that it is obvious to the user, replace the cartridge and continue until all three
drops have been performed.
b) Pen-injectors with non-replaceable cartridges
1) Expel the air.
2) Take off the needle and put on the cap.
3) Drop the pen-injectors by free fall from a height of 1 000 mm onto the test surface (see 8.3) in accordance
with i), ii) and iii), as follows:
6 © ISO 2000 – All rights reserved

---------------------- Page: 18 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
i) Horizontal
Drop a minimum of 10 new pen-injectors in a non-turbulent way. If a cartridge breaks such that it is
obvious to the user, exclude the pen-injector from further testing.
ii) Vertical A
Drop a minimum of 10 new pen-injectors in a non-turbulent way. If a cartridge breaks such that it is
obvious to the user, exclude the pen-injector from further testing.
iii) Vertical B [180° from orientation ii)]
Drop a minimum of 10 new pen-injectors in a non-turbulent way. If a cartridge breaks such that it is
obvious to the user, exclude the pen-injector from further testing.
7.5 Preconditioning by vibration for pen-injectors with electronic components
Vibrate the pen-injector with its cartridge and needle in each of three axes in accordance with IEC 60068-2-6 and
Table 1.
Table 1 — Vibration amplitudes with lower cross-over frequency: IEC 60068-2-6:1995, Table IV and Figure 1
a
Displacement/Acceleration
Number of sweeps
Frequency range
(peak value)
per direction
3Hzto8 Hz 7,5mm 4
8Hzto300Hz 2g 4
a
The sweep speed shall be 1 octave per minute.
8 Reagent and apparatus
8.1 Test liquid, i.e. the original medicinal product intended to be injected by the pen-injector or a liquid which
gives the same results.
8.2 Balance, with a maximum tolerance of 1 % of the minimum dose delivery.
8.3 Test surface, smooth, hard, rigid steel of 3 mm thickness backed by wood of between 10 mm and 19 mm
thickness.
8.4 Needle connector for connecting the needle to a tube.
9 Determination of dose accuracy
9.1 Dose accuracy
9.1.1 General
Dose accuracy is determined by selecting and testing a variable number of pen-injectors. The number of pen-
injectors depends upon the cartridge and accuracy requirements for a given test. Assuming that the accuracy
measurements are normally distributed and that each measurement is independent, the following method enables
accuracy measurements to be used as the basis for determining a statistical tolerance interval for three dose
settings (the minimum, midpoint and maximum dose settings for a given pen-injector), i.e. an interval such that
there is a fixed probability (confidence level) that the interval will contain at least a proportion (p, probability content)
© ISO 2000 – All rights reserved 7

---------------------- Page: 19 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
of the true population from which the sample is taken. The statistical tolerance interval is two-sided, and the limits
of the interval are called “statistical tolerance limits” or “natural limits of the process”.
To pass the dose accuracy requirement, there shall be a 95 % confidence that at least p of all doses delivered will
fall within the proposed upper and lower specification limits for the three dose settings.
The two-sided statistical tolerance interval is calculated using the mean ( x ) plus or minus the standard deviation
(s) multiplied by a tolerance limit factor (k):
xk��s
where
x is the mean of the sample;
k is the tolerance limit factor;
s is the standard deviation of the sample.
The factor is determined based upon the confidence level (95 %), probability content (p), and the number of
[1]
measurements (n) taken for each of the three dose settings. ISO 3207:1975 , Table 8, lists the tolerance limit
factors for the construction of two-sided statistical tolerance intervals when the true population mean and standard
deviation are not known. Annex A contains a more comprehensive two-sided tolerance limit for the 95 %
confidence level.
9.1.2 Accuracy assessment (expressed in millilitres)
If V u TP, then:
set
U = V +�;
set
L = V ��.
set
If V > TP, then:
set
U = V +(� · V ) / 100;
set set
L = V � (� · V ) / 100.
set set
A pen-injector population's accuracy satisfies the requirements when, for a given V , the following are fulfilled:
set
xk��()s uU; and
xk��().s WL
9.1.3 Example of accuracy limit calculation
In the following an example of calculation (volumes expressed as millilitres) is given for a single-compartment
cartridge:
If V :
set
V =0,02ml;
min
V =0,16ml;
mid
V =0,30ml;
max
8 © ISO 2000 – All rights reserved

---------------------- Page: 20 ----------------------

SIST EN ISO 11608-1:2001
ISO 11608-1:2000(E)
and:
� =0,01ml;
� =5%;
then:
TP =(100� 0,01 ml)/5 = 0,20 ml;
For V u TP: U = (0,02 + 0,01) ml = 0,030 ml;
min
L = (0,02� 0,01) ml = 0,010 ml;
For V u TP: U = (0,16 + 0,01) ml = 0,170 ml;
mid
L = (0,16� 0,01) ml = 0,150 ml;
For V > TP: U=0,30ml+ (5 × 0,30 ml)/100 = 0,315 ml;
max
L =0,30ml� (5 × 0,30 ml)/100 = 0,285 ml.
9.1.4 Procedure
9.1.4.1 General
All doses (V ) delivered are recorded gravimetrically (G , expressed in grams). These recordings are
set meas
converted to volumes (V )by using the density (�, expressed in grams per millilitre) for the test fluid. The
meas
following equation can be used to convert gravimetric measurements to volumetric:
V = G / �
meas meas
9.1.4.2 Accuracy requiremen
...