EN ISO 11608-5:2012
(Main)Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
ISO 11608-5:2012 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.
Kanülenbasierte Injektionssysteme zur medizinischen Anwendung - Anforderungen und Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2012)
Dieser Teil der ISO 11608 legt Anforderungen an und Prüfverfahren für die automatisierten Funktionen von kanülenbasierten Injektionssystemen mit automatisierten Funktionen (NIS AUTO) zur Verabreichung von Arzneimitteln an Menschen fest, die Folgendes umfassen, jedoch nicht allein darauf beschränkt sind:
a) Arzneimittelzubereitung (z. B. Rekonstitution);
b) Vorbereitung der Kanüle;
c) Entlüftung;
d) Betriebsbereitmachen;
e) Einstellen der Dosis;
f) Betätigung;
g) Einführen der Kanüle;
h) Injizieren des Arzneimittels;
i) Deaktivieren des NIS AUTOs;
j) Einziehen der Kanüle;
k) Schutzschild der Kanüle;
l) Verdeckung (Sichtschutz) der Injektionskanüle;
m) Schutz vor Schnitt und Stichverletzungen;
n) Entfernen der Kanüle.
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 5: Fonctions automatisées (ISO 11608-5:2012)
L'ISO 11608-5:2012 spécifie les exigences et méthodes d'essai pour les fonctions automatisées des systèmes d'injection à aiguille dotés de fonctions automatisées (NIS‑AUTO) pour l'administration de produits médicaux chez l'homme.
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del: Avtomatizirane funkcije (ISO 11608-5:2012)
Ta del standarda ISO 11608 določa zahteve in poskusne metode za avtomatizirane funkcije peres za injiciranje z avtomatiziranimi funkcijami (NIS-AUTO), ki so namenjene upravljanju z zdravstvenimi izdelki pri ljudeh in med drugim vključujejo tudi:
a) pripravo zdravil (npr. obnova);
b) pripravo igel;
c) odstranitev zraka;
d) vbrizgavanje;
e) priprava odmerka;
f) odmerjanje;
g) vstavljanje igle;
h) vbrizg zdravstvenega izdelka;
i) onemogočanje peresa za injiciranje z avtomatiziranimi funkcijami;
j) izvlečenje igle;
k) zaščito igle;
l) prikrivanje igle;
m) zaščito pred poškodbami zaradi ostrih predmetov;
n) odstranitev igle.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11608-5:2013
01-januar-2013
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del:
Avtomatizirane funkcije (ISO 11608-5:2012)
Needle-based injection systems for medical use - Requirements and test methods - Part
5: Automated functions (ISO 11608-5:2012)
Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2012)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 5: Fonctions automatisées (ISO 11608-5:2012)
Ta slovenski standard je istoveten z: EN ISO 11608-5:2012
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11608-5:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11608-5:2013
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SIST EN ISO 11608-5:2013
EUROPEAN STANDARD
EN ISO 11608-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2012
ICS 11.040.25
English Version
Needle-based injection systems for medical use - Requirements
and test methods - Part 5: Automated functions (ISO 11608-
5:2012)
Systèmes d'injection à aiguille pour usage médical - Nadelbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 5: Fonctions Verwendung - Anforderungen und Prüfverfahren - Teil 5:
automatisées (ISO 11608-5:2012) Automatisierte Funktionen (ISO 11608-5:2012)
This European Standard was approved by CEN on 29 September 2012.
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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-5:2012: E
worldwide for CEN national Members.
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SIST EN ISO 11608-5:2013
EN ISO 11608-5:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 11608-5:2013
EN ISO 11608-5:2012 (E)
Foreword
This document (EN ISO 11608-5:2012) has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and intravascular catheters" in collaboration with 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 April 2013, and conflicting national standards shall be withdrawn at the
latest by April 2013.
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.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Es
...
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