EN ISO 11608-1:2012

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012)

DOW = DAV + 36 months
2011-07-20 ANP: Text received in ISO/CS (see notification from 2011-07-20 in dataservice).
2010-08-18 EMA: ENQ draft received in ISO/CS according to notification received in dataservice on 2010-08-18.

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 1: Kanülenbasierte Injektionssysteme (ISO 11608-1:2012)

Dieser Teil von ISO 11608 legt Anforderungen an und Prüfverfahren für kanülenbasierte Injektionssysteme (en: needle-based injections systems, NISs) fest, die zur Verwendung mit Kanülen und erneuerbaren oder nichterneuerbaren Behältern bestimmt sind. Die von dem vorliegenden Teil von ISO 11608 erfassten Behälter umfassen durch den Hersteller oder den Endanwender befüllte spritzenbasierte und karpulenbasierte Systeme für eine Einzeldosis und Mehrfachdosen.
Zusätzliche Anleitungen für NIS, die mit elektronischen oder elektromechanischen Bauteilen ausgestattet sind, und NISs, die mit automatisierten Funktionen ausgestattet sind, werden in ISO 11608-4 bzw. ISO 11608-5 gegeben.
Kanülenlose Injektoren und Anforderungen bezogen auf Verfahren oder Vorrichtungen im Zusammenhang mit dem Füllen von Behältern durch den Endbenutzer liegen nicht im Anwendungsbereich dieses Teils von ISO 11608.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 1: Systèmes d'injection à aiguille (ISO 11608-1:2012)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 1. del: Peresa za injiciranje (ISO 11608-1:2012)

Ta del standarda ISO 11608 določa zahteve in preskusne metode za peresa za injiciranje (NIS), ki naj bi se uporabljala z iglami in zamenljivimi ali nezamenljivimi posodicami. Posodice, zajete v tem delu standarda ISO 11608, vključujejo sisteme na osnovi brizge in bombic za enega ali več odmerkov, ki jih napolni proizvajalec ali končni uporabnik. Dodatna navodila za peresa za injiciranje, opremljena z elektronskimi ali elektromehanskimi sestavnimi deli, in peresa z avtomatiziranimi funkcijami so na voljo v standardu ISO 11608-4 za prva in standardu ISO 11608-5 za slednja. Peresa brez igel in zahteve glede metod ali opreme, pri katerih posodice napolni končni uporabnik, ne spadajo na področje uporabe tega dela standarda ISO 11608.

General Information

• Status: Withdrawn
• Publication Date: 31-Mar-2012
• Withdrawal Date: 13-Jan-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 14-Jan-2015
• Completion Date: 14-Jan-2015
• Ref Project: SIST EN ISO 11608-1:2012 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012)

Relations

• Replaces: EN ISO 11608-1:2000 - Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods (ISO 11608-1:2000)
• Effective Date: 11-Apr-2012
• Replaced By: EN ISO 11608-1:2015 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
11-september-2012
1DGRPHãþD
SIST EN ISO 11608-1:2001
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 1. del:
Peresa za injiciranje (ISO 11608-1:2012)
Needle-based injection systems for medical use - Requirements and test methods - Part
1: Needle-based injection systems (ISO 11608-1:2012)
Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 1: Nadelbasierte Injektionssysteme (ISO 11608-1:2012)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 1: Systèmes d'injection à aiguille (ISO 11608-1:2012)
Ta slovenski standard je istoveten z: EN ISO 11608-1:2012
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 11608-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2012
ICS 11.040.25 Supersedes EN ISO 11608-1:2000
English Version
Needle-based injection systems for medical use - Requirements
and test methods - Part 1: Needle-based injection systems (ISO
11608-1:2012)
Systèmes d'injection à aiguille pour usage médical - Nadelbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 1: Systèmes Verwendung - Anforderungen und Prüfverfahren - Teil 1:
d'injection à aiguille (ISO 11608-1:2012) Nadelbasierte Injektionssysteme (ISO 11608-1:2012)
This European Standard was approved by CEN on 31 March 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, 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 11608-1:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (EN ISO 11608-1:2012) 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 October 2012, and conflicting national standards shall be withdrawn at
the latest by October 2012.
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 11608-1:2000.
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, 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 11608-1:2012 has been approved by CEN as a EN ISO 11608-1:2012 without any
modification.
INTERNATIONAL ISO
STANDARD 11608-1
Second edition
2012-04-01
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 11608-1:2012(E)
©
ISO 2012
ISO 11608-1:2012(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
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Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 11608-1:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 3
5 Requirements . 4
5.1 General . 4
5.2 System designations . 4
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 . 8
7.4 Assessment . 9
8 Preparation and operation of NISs .12
9 Test matrix .12
10 Test descriptions .15
10.1 General .15
10.2 Cool, standard and warm atmosphere testing .15
10.3 Last-dose testing (system designations A and C only) .16
10.4 Life-cycle testing (systems designations A and B only) — Pre-conditioning .16
10.5 Free-fall testing .16
10.6 Dry-heat and cold-storage testing — Pre-conditioning .18
10.7 Damp-heat testing (system designations A and B only) — Pre-conditioning .18
10.8 Cyclical testing (system designations A and B only) — Pre-conditioning .18
10.9 Vibration testing — Pre-conditioning .18
10.10 Electromagnetic compatibility (EMC) (systems with electronics only) .19
11 Inspection .20
11.1 Visual inspection .20
11.2 Container inspection .20
11.3 Dose accuracy acceptance criteria .20
12 Test report .21
13 Information supplied by the manufacturer .22
13.1 General .22
13.2 Marking .22
13.3 Instructions for use .23
Annex A (informative) Dose replicates, accuracy and testing rationale .25
Annex B (normative) One- and two-sided tolerance limit factors, k .29
Bibliography .40
ISO 11608-1:2012(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
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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 vo
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