EN ISO 11608-1:2015

SLOVENSKI STANDARD
01-marec-2015
1DGRPHãþD
SIST EN ISO 11608-1:2012
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 1. del:
Peresa za injiciranje (ISO 11608-1:2014)
Needle-based injection systems for medical use - Requirements and test methods - Part
1: Needle-based injection systems (ISO 11608-1:2014)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 1: Kanülenbasierte Injektionssysteme (ISO 11608-1:2014)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 1: Systèmes d'injection à aiguille (ISO 11608-1:2014)
Ta slovenski standard je istoveten z: EN ISO 11608-1:2015
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 11608-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2015
ICS 11.040.25 Supersedes EN ISO 11608-1:2012
English Version
Needle-based injection systems for medical use - Requirements
and test methods - Part 1: Needle-based injection systems (ISO
11608-1:2014)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 1: Systèmes Verwendung - Anforderungen und Prüfverfahren - Teil 1:
d'injection à aiguille (ISO 11608-1:2014) Kanülenbasierte Injektionssysteme (ISO 11608-1:2014)
This European Standard was approved by CEN on 11 October 2014.

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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-1:2015 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 11608-1:2015) has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and 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 July 2015, and conflicting national standards shall be withdrawn at the
latest by July 2015.
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 supersedes EN ISO 11608-1:2012.
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 organizations 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 11608-1:2014 has been approved by CEN as EN ISO 11608-1:2015 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC, 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 normative clauses of
this standard confers, within the limits of the scope of this standard, a presumption of conformity with the
relevant Essential Requirements of that Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 11608-1
Third edition
2014-12-15
Needle-based injection systems for
medical use — Requirements and
test methods —
Part 1:
Needle-based injection systems
Systèmes d’injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 1: Systèmes d’injection à aiguille
Reference number
ISO 11608-1:2014(E)
©
ISO 2014
ISO 11608-1:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
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Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 11608-1:2014(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 3
5 Requirements . 4
5.1 General . 4
5.2 System designations . 5
5.3 Risk analysis requirements . 5
5.4 Uncertainty of measurement and conformance with specifications. 5
5.5 General design requirements . 5
6 Reagent and apparatus . 7
6.1 General . 7
6.2 Test liquid . 7
6.3 Balance . 7
6.4 Test surface for free-fall testing . 7
7 Determination of dose accuracy. 7
7.1 General . 7
7.2 Dosing regions . 8
7.3 Dose settings . 9
7.3.1 Multi-dose containers (system designations A and C) . 9
7.3.2 Single-dose containers (system designations B and D) . 9
7.4 Assessment . 9
7.4.1 General. 9
7.4.2 Determination of dose accuracy limits .10
7.4.3 Determination of last-dose error and last-dose accuracy limits (system
designations A and C) .11
7.4.4 Calculation of dose delivery efficiency (system designations B1 and
D1, user-filled) .11
7.4.5 Calculation of tolerance intervals .12
8 Preparation and operation of NISs .12
9 Test matrix .13
10 Test descriptions .16
10.1 General .16
10.2 Cool, standard and warm atmosphere testing .16
10.2.1 Pre-conditioning .16
10.2.2 Testing .
...