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CEN

EN ISO 11608-1:2015

(Main)

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

ISO 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in ISO 11608-1:2014 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.

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)

L'ISO 11608-1:2014 spécifie les exigences et les méthodes d'essai des systèmes d'injection à aiguille (NIS) destinés à être utilisés avec des aiguilles et des conteneurs remplaçables ou non remplaçables. Les conteneurs couverts par l'ISO 11608-1:2014 comprennent les systèmes à seringue et à cartouche à dose unique ou à doses multiples, qu'ils soient remplis par le fabricant ou par l'utilisateur final.

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 1. del: Peresa za injiciranje (ISO 11608-1:2014)

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 za injiciranje
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Withdrawn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
13-Jan-2015
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
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST 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)

Relations

Replaces
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)
Effective Date
08-Jun-2022
Replaced By
EN ISO 11608-1:2022 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)
Effective Date
11-May-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11608-1:2015
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
SIST EN ISO 11608-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11608-1:2015

---------------------- Page: 2 ----------------------

SIST EN ISO 11608-1:2015

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.

---------------------- Page: 3 ----------------------

SIST EN ISO 11608-1:2015
EN ISO 11608-1:2015 (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

---------------------- Page: 4 ----------------------

SIST EN ISO 11608-1:2015
EN ISO 11608-1:2015 (E)
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 org
...

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Excluded from the scope are:
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—    NISs with containers that can be refilled multiple times;
—    requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories (a component necessary for primary function, whether included in the original kitted product or not);
—    NISs intended for dental use;
—    NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).
NOTE       These products that are excluded might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of such products.

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