EN ISO 11608-4:2007

Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)

ISO 11608-4:2006 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.

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

• Status: Withdrawn
• Publication Date: 28-Aug-2007
• Withdrawal Date: 03-May-2022
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 04-May-2022
• Ref Project: SIST EN ISO 11608-4:2008 - Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)

Relations

• Replaced By: EN ISO 11608-4:2022 - Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
• Effective Date: 11-May-2022
• Revised: prEN ISO 11608-4 - Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)
• Effective Date: 08-Jun-2022

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.

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SIST EN ISO 11608-4:2008

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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.

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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.
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