Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods (ISO 11608-3:2000)

Specifies performance and interchangeability dimensions of single use cartridges for drugs for use with pen-injectors

Pen-Injektoren zur medizinischen Anwendung - Teil 3: Fertigkarpulen - Anforderungen und Prüfverfahren (ISO 11608-3:2000)

Diese Internationale Norm legt die Leistung und das Prüfverfahren für Einkammer-Mehrfachdosierungskarpulen (vorgefüllte Fertigkarpulen), die als Primärbehälter in Pen-Injektoren dienen und die die Festlegungen von ISO 11608-1 erfüllen, fest. Diese Norm gilt nicht für Mehrkammerkarpulen, vom Anwender zu füllende Karpulen und für Karpulen, die zur zahnmedizinischen Anwendung vorgesehen sind.

Stylos-injecteurs à usage médical - Partie 3: Cartouches prêtes à l'emploi - Exigences et méthodes d'essai (ISO 11608-3:2000)

La présente partie de l'ISO 11608 spécifie les performances et les méthodes d'essai relatives aux cartouches préremplies multidoses à chambre simple servant d'emballages primaires dans les stylos-injecteurs conformes aux spécifications de l'ISO 11608. Elle spécifie la conception et les dimensions relatives aux cartouches de type A. La présente partie de l'ISO 11608 ne s'applique pas aux cartouches multichambres, les cartouches que l'utilisateur remplit lui-même ni les cartouches pour usage dentaire.

Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods (ISO 11608-3:2000)

General Information

Status
Withdrawn
Publication Date
14-Dec-2000
Withdrawal Date
30-Sep-2012
Current Stage
9960 - Withdrawal effective - Withdrawal
Due Date
01-Oct-2012
Completion Date
01-Oct-2012

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SLOVENSKI STANDARD
SIST EN ISO 11608-3:2001
01-november-2001

Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test

methods (ISO 11608-3:2000)

Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test

methods (ISO 11608-3:2000)

Pen-Injektoren zur medizinischen Anwendung - Teil 3: Fertigkarpulen - Anforderungen

und Prüfverfahren (ISO 11608-3:2000)

Stylos-injecteurs a usage médical - Partie 3: Cartouches pretes a l'emploi - Exigences et

méthodes d'essai (ISO 11608-3:2000)
Ta slovenski standard je istoveten z: EN ISO 11608-3:2000
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11608-3:2001 en

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

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SIST EN ISO 11608-3:2001
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SIST EN ISO 11608-3:2001
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SIST EN ISO 11608-3:2001
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SIST EN ISO 11608-3:2001
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SIST EN ISO 11608-3:2001
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SIST EN ISO 11608-3:2001
INTERNATIONAL ISO
STANDARD 11608-3
First edition
2000-12-15
Pen-injectors for medical use —
Part 3:
Finished cartridges — Requirements
and test methods
Stylos-injecteurs à usage médical —
Partie 3: Cartouches prêtes à l'emploi — Exigences et méthodes d'essai
Reference number
ISO 11608-3:2000(E)
ISO 2000
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SIST EN ISO 11608-3:2001
ISO 11608-3:2000(E)
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ii © ISO 2000 – All rights reserved
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SIST EN ISO 11608-3:2001
ISO 11608-3:2000(E)
Contents Page

Foreword.....................................................................................................................................................................iv

Introduction.................................................................................................................................................................v

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

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

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

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

4.1 Freedom from leakage ..................................................................................................................................3

4.2 Initiating force ................................................................................................................................................3

4.3 Sustaining force.............................................................................................................................................3

4.4 Dimensions.....................................................................................................................................................3

4.5 Eccentricity.....................................................................................................................................................4

4.6 Visibility of the medicinal product ...............................................................................................................4

4.7 Meniscus.........................................................................................................................................................5

4.8 Resealability...................................................................................................................................................5

4.9 Cap ..................................................................................................................................................................5

4.10 Plunger and disc............................................................................................................................................5

4.11 Material of the cylinder..................................................................................................................................5

4.12 Lubrication .....................................................................................................................................................5

4.13 Dose accuracy................................................................................................................................................5

4.14 Deliverable volume and last-dose accuracy...............................................................................................5

5 Test methods..................................................................................................................................................6

5.1 Test apparatus ...............................................................................................................................................6

5.2 Test conditions ..............................................................................................................................................6

5.3 Test fluid.........................................................................................................................................................7

5.4 Analytical approach.......................................................................................................................................7

5.5 Leakage (attribute).........................................................................................................................................7

5.6 Forces required to initiate and sustain plunger movement (attribute) ....................................................8

5.7 Dimensions (attribute)...................................................................................................................................8

5.8 Eccentricity (attribute)...................................................................................................................................8

5.9 Meniscus (attribute).....................................................................................................................................11

5.10 Resealability (attribute) ...............................................................................................................................11

5.11 Dose accuracy (variable) ............................................................................................................................11

5.12 Deliverable volume (attribute) ....................................................................................................................12

5.13 Last-dose accuracy (variable) ....................................................................................................................12

6 Information supplied by the manufacturer ...............................................................................................13

Bibliography..............................................................................................................................................................14

© ISO 2000 – All rights reserved iii
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SIST EN ISO 11608-3:2001
ISO 11608-3:2000(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 11608-3 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
iv © ISO 2000 – All rights reserved
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SIST EN ISO 11608-3:2001
ISO 11608-3:2000(E)
Introduction

This part of ISO 11608 covers finished cartridges filled with medicinal products 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 11608-1

and ISO 11608-2.

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 designs 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 interchangeable (Type A) and non-interchangeable (non-Type A)

cartridges. Additional dimensional requirements are imposed on interchangeable cartridges (Type A).

Information as to whether the components are interchangeable (Type A) or not will be given on the secondary

container.

It is desirable that non-Type A cartridges do not fit pen-injectors intended for type A cartridges.

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 finished cartridges 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.

Regulatory authorities, pharmacopoeia and relevant trade associations should recognize the need for further

testing, especially regarding compatibility between the medicinal products and cartridge as they are in contact for

prolonged periods.

In some countries, national pharmacopoeia or government regulations exist and their requirements may take

precedence over or complement this part of ISO 11608. In particular, materials in contact with the medicinal

product shall comply with all relevant pharmacopoeia requirements.
© ISO 2000 – All rights reserved v
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SIST EN ISO 11608-3:2001
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SIST EN ISO 11608-3:2001
INTERNATIONAL STANDARD ISO 11608-3:2000(E)
Pen-injectors for medical use —
Part 3:
Finished cartridges — Requirements and test methods
1 Scope

This part of ISO 11608 specifies performance and test methods for multidose, single-chamber, pre-filled, finished

cartridges used as primary containers in pen-injectors fulfilling the specifications of ISO 11608-1. Design and

dimensions are specified for Type A cartridges.

This part of ISO 11608 is not applicable to multichamber cartridges, cartridges that are filled by the user, and

cartridges intended for dental use.
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 3207, Statistical interpretation of data — Determination of a statistical tolerance interval.

ISO 11608-1:2000, Pen-injectors for medical use — Part 1: Pen-injectors — Requirements and test methods.

ISO 13926-1:1998, Pen systems — Part 1: Glass cylinders for pen-injectors for medical use.

3 Terms and definitions

For the purposes of this part of ISO 11608, the following terms and definitions apply.

The nomenclature of some of the cartridge components is illustrated in Figure 1.
3.1
cartridge
primary container for the medicinal product
3.2
unit container
package intended for customer use
3.3
cylinder
main body of the cartridge
© ISO 2000 – All rights reserved 1
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SIST EN ISO 11608-3:2001
ISO 11608-3:2000(E)
3.4
plunger

component which seals one end of the cartridge and interfaces with the plunger rod of the del

...

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