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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
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, 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 the United Kingdom.
Endorsement notice
The text of ISO 11608-5:2012 has been approved by CEN as a EN ISO 11608-5:2012 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical Devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
on medical devices
Clause(s)/subclause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
European Standard Directive 93/42/EEC
Clauses 4.1 to 4.3, all parts 1 Clause 10, all parts of ISO 11608-1
addresses pre-conditioning
Clauses 4.1 to 4.4, all parts 2 Clause 10, all parts of ISO 11608-1
addresses pre-conditioning
Clauses 4.1 to 4.3, 5, 6, all parts 3 All clauses of ISO 11608-1 are
applicable
NA 4
NA 5
Clause 4.1 parts E and G, clause 6
4.3 all parts
Clauses 4.2.2 and 5.1.1 7 Only 7.3 is addressed
Clause 4.1 parts D 8 Only 8.3 is addressed
Clauses 4.1 to 4.4, all parts 9 9.3 is not addressed
Clause 10, all parts of ISO 11608-1
addresses pre-conditioning
Clauses 4.2.5, 4.3.3.3, 4.3.5.1, 10 All clauses of ISO 11608-1 are
5.1.4, 5.1.7, 5.1.8.1 and 5.2 applicable
NA 11
NA 12
Clause 7 13 13.5 is not addressed
Clause 5.4, part D and Q and
Clause 13, all parts of ISO 11608-1
address ER 13
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 11608-5
First edition
2012-10-01
Needle-based injection systems for medical
use — Requirements and test methods —
Part 5:
Automated functions
Systèmes d’injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 5: Fonctions automatisées
Reference number
ISO 11608-5:2012(E)
©
ISO 2012
ISO 11608-5:2012(E)
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
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E-mail copyright@iso.org
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Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 11608-5:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 General requirements . 3
4.2 Preparation . 4
4.3 Injection . 5
4.4 Risk analysis requirements . 8
5 Test methods . 8
5.1 General . 8
5.2 Dose specification requirements . 11
5.3 Uncertainty of measurements and conformance with specifications .12
6 Test report .12
7 Information to be supplied by the manufacturer .12
Annex A (informative) Rationale for requirements .13
Bibliography .15
ISO 11608-5:2012(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 11608-5 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 Needle-based injection systems for medical
use — Requirements and test methods:
— Part 1: Needle-based injection systems
— Part 2: Needles
— Part 3: Finished containers
— Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
— Part 5: Automated functions
iv © ISO 2012 – All rights reserved
ISO 11608-5:2012(E)
Introduction
This part of ISO 11608 is applicable to needle-based injection systems with automated functions (NIS-
AUTO), primarily intended to administer medicinal products to humans. Because of the anticipated variation
in the designs of NIS-AUTOs, this part of ISO 11608 is promulgated more as a “horizontal” than a “vertical”
standard. Thus, it tends to specify the results of the design effort instead of the physical and construction
requirements used as the basis for NIS-AUTO design, so that innovation in achieving the intended purposes is
not unnecessarily restricted.
This part of ISO 11608 intentionally avoids addressing more than the most basic elements regarding the safety
and performance of NIS-AUTOs in humans. Any intended labelling of such NIS-AUTOs indicating their use to
deliver medicinal products into the body or into specified tissue strata thereof (e.g. intramuscular, subcutaneous
or intradermal), or for the administration of specific pharmaceutical drugs or vaccines, falls under the authority
of national governments or supranational agencies regulating the manufacture and marketing of medical NIS-
AUTOs and pharmaceutical products.
This part of ISO 11608 is expected to be supplemented by additio
...
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