EN ISO 11608-1:2000
(Main)Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods (ISO 11608-1:2000)
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 à 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
ISO 11608-1:2000(E)
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ii © ISO 2000 – All rights reserved
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 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
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.
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: Need
...
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