SIST EN ISO 11608-4:2008
(Main)Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for single-use or multiple-use. The injector system is intended to deliver medication to an end-user by self-administration or with assistance. This part of ISO 11608 is neither applicable for needle-free injectors (as covered in ISO 21649) nor infusion pumps (as covered in IEC 60601-2-24). This part of ISO 11608 is not applicable for devices that are capable of operating while connected to an external power supply.
Pen-Injektoren zur medizinischen Anwendung - Teil 4: Anforderungen an und Prüfverfahren für elektronische und elektromechanische Pen-Injektoren (ISO 11608-4:2006)
Dieser Teil der ISO 11608 legt Anforderungen und Prüfverfahren für elektromechanisch angetriebene Injektoren fest, die zur Verwendung mit Kanülen und austauschbaren oder nichtaustauschbaren Karpulen bestimmt sind. Der Injektor kann für den Einmal- oder Mehrfachgebrauch vorgesehen sein. Das Injektor¬system ist dazu vorgesehen, die Arzneigabe durch Eigenanwendung oder mit Unterstützung an einen Endver¬braucher abzugeben.
Dieser Teil der ISO 11608 gilt weder für nadelfreie Injektoren (wie in ISO 21649 behandelt) noch für Infusions¬pumpen (wie in IEC 60601-2-24 behandelt).
Dieser Teil der ISO 11608 ist nicht anwendbar auf Geräte, die betrieben werden können, während sie an eine externe Energiezufuhr angeschlossen sind.
Stylos-injecteurs à usage médical - Partie 4: Exigences et méthodes d'essai pour stylos-injecteurs électroniques et électro-mécaniques (ISO 11608-4:2006)
L'ISO 11608-4:2006 spécifie les exigences et les méthodes d'essai relatives aux stylos-injecteurs destinés à être utilisés avec des aiguilles et des cartouches remplaçables ou non remplaçables. Le stylo-injecteur peut servir pour un usage unique ou pour un usage multiple. Le système d'injection est destiné à délivrer le médicament à l'utilisateur final par auto-administration ou grâce à une aide.
Peresa za injiciranje za uporabo v medicini - 4. del: Zahteve in preskusne metode za elektronska in elektromehanska peresa za injiciranje (ISO 11608-4:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11608-4:2008
01-april-2008
Peresa za injiciranje za uporabo v medicini - 4. del: Zahteve in preskusne metode
za elektronska in elektromehanska peresa za injiciranje (ISO 11608-4:2006)
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and
electromechanical pen-injectors (ISO 11608-4:2006)
Pen-Injektoren zur medizinischen Anwendung - Teil 4: Anforderungen an und
Prüfverfahren für elektronische und elektromechanische Pen-Injektoren (ISO 11608-
4:2006)
Stylos-injecteurs à usage médical - Partie 4: Exigences et méthodes d'essai pour stylos-
injecteurs électroniques et électro-mécaniques (ISO 11608-4:2006)
Ta slovenski standard je istoveten z: EN ISO 11608-4:2007
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11608-4:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 11608-4:2008
---------------------- Page: 2 ----------------------
SIST EN ISO 11608-4:2008
EUROPEAN STANDARD
EN ISO 11608-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2007
ICS 11.040.25
English Version
Pen-injectors for medical use - Part 4: Requirements and test
methods for electronic and electromechanical pen-injectors (ISO
11608-4:2006)
Stylos-injecteurs à usage médical - Partie 4: Exigences et Pen-Injektoren zur medizinischen Anwendung - Teil 4:
méthodes d'essai pour stylos-injecteurs électroniques et Anforderungen an und Prüfverfahren für elektronische und
électro-mécaniques (ISO 11608-4:2006) elektromechanische Pen-Injektoren (ISO 11608-4:2006)
This European Standard was approved by CEN on 9 August 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-4:2007: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11608-4:2008
EN ISO 11608-4:2007 (E)
Foreword
The text of ISO 11608-4:2006 has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and intravascular catheters” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 11608-4:2007 by
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 February 2008, and conflicting national
standards shall be withdrawn at the latest by February 2008.
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.
ISO 11608-4 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
— Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
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, 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 and the United
Kingdom.
Endorsement notice
The text of ISO 11608-4:2006 has been approved by CEN as EN ISO 11608-4:2007 without any
modifications.
2
---------------------- Page: 4 ----------------------
SIST EN ISO 11608-4:2008
INTERNATIONAL ISO
STANDARD 11608-4
First edition
2006-03-15
Pen-injectors for medical use —
Part 4:
Requirements and test methods for
electronic and electromechanical
pen-injectors
Stylos-injecteurs à usage médical —
Partie 4: Exigences et méthodes d'essai pour stylos-injecteurs
électroniques et électro-mécaniques
Reference number
ISO 11608-4:2006(E)
©
ISO 2006
---------------------- Page: 5 ----------------------
SIST EN ISO 11608-4:2008
ISO 11608-4:2006(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 2006
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 2006 – All rights reserved
---------------------- Page: 6 ----------------------
SIST EN ISO 11608-4:2008
ISO 11608-4:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Symbols and abbreviated terms . 2
5 General requirements. 2
6 Test conditions . 2
7 Preconditioning of pen-injectors . 2
8 Reagent and apparatus . 5
9 Determination of dose accuracy . 5
10 Freedom from defects . 6
11 Determination of electromagnetic compatibility . 7
12 Electrical safety. 7
13 Visual inspection . 8
14 Functional inspection. 8
15 Test report . 8
16 Information supplied by the manufacturer .9
Bibliography . 10
© ISO 2006 – All rights reserved iii
---------------------- Page: 7 ----------------------
SIST EN ISO 11608-4:2008
ISO 11608-4:2006(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 11608-4 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.
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
⎯ Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
iv © ISO 2006 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11608-4:2008
ISO 11608-4:2006(E)
Introduction
This part of ISO 11608 covers electro-mechanical driven injectors not covered by part 1 of ISO 11608. These
injectors are mainly intended to administer medicinal products to humans. This part of ISO 11608 provides
performance requirements regarding essential aspects of the design so that variations of such injectors are
not unnecessarily restricted.
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 injectors that conforms to the critical
product attributes. These sampling plans for inspection do not intend to replace the more general
manufacturing quality systems practices widely used in production, e.g. the ISO 9000 series.
Materials to be used for the construction of these injectors are not specified, as their selection, to some extent,
will depend upon the design, the intended use and the manufacturing process selected by the manufacturer.
All materials used in these injectors which come in contact with the end-user must be non-toxic and
biocompatible. In some countries, national regulations may exist and their requirements may supersede or
add up to this part of ISO 11608.
In relation to specification limits and dose accuracy, the ISO directives (Part 2, A3 and A13) require that the
[1] [2]
VIM and GUM principles are used and incorporated in all future standards and future revisions of existing
standards. The reorganization to be done in relation to this will not affect the technical content of the
standards, and only the terminology shall be changed to correspond to VIM, and the principles shall be
changed to correspond to GUM.
However, with this part of ISO 11608, ISO/TC 84 has decided to await the revision of the ISO 11608 series
where the principles will be incorporated in all parts to conform to applicable requirements.
© ISO 2006 – All rights reserved v
---------------------- Page: 9 ----------------------
SIST EN ISO 11608-4:2008
---------------------- Page: 10 ----------------------
SIST EN ISO 11608-4:2008
INTERNATIONAL STANDARD ISO 11608-4:2006(E)
Pen-injectors for medical use —
Part 4:
Requirements and test methods for electronic and
electromechanical pen-injectors
1 Scope
This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors
intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for
single-use or multiple-use. The injector system is intended to deliver medication to an end-user by
self-administration or with assistance.
This part of ISO 11608 is neither applicable for needle-free injectors (as covered in ISO 21649) nor infusion
pumps (as covered in IEC 60601-2-24).
This part of ISO 11608 is not applicable for devices that are capable of operating while connected to an
external power supply.
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 11608-1:2000, Pen-injectors for medical use — Part 1: Pen-injectors — Requirements and test methods
IEC 60068-2-27:1987, Environmental testing — Part 2: Tests. Test Ea and guidance: Shock
IEC 60068-2-30:1980, Environmental testing — Part 2-30: Tests — Test Db: Damp heat, cyclic (12 h + 12 h
cycle)
IEC 60068-2-64:1993, Environmental testing — Part 2: Test methods — Test Fh: Vibration, broad-band
random (digital control) and guidance
IEC 60529:2001, Degrees of protection provided by enclosures (IP Code)
IEC 60601-1:1988, Edition 2: Medical electrical equipment — Part 1: General requirements for safety
(+ AMD 1:1991 + AMD. 2: 1995)
IEC 60601-1-1:2000, Medical electrical equipment — Part 1-1: General requirements for safety — Collateral
standard: Safety requirements for medical ele
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.