EN ISO 11608-2:2012

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)

ISO 11608-2:2012 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 2: Kanülen (ISO 11608-2:2012)

Dieser Teil von ISO 11608 legt Anforderungen an und Prüfverfahren für sterile Kanülen mit beidseitigem Anschliff fest, die für den Einmalgebrauch in kanülenbasierten Injektionssystemen (en: neadle-based injection systems, NISs) vorgesehen sind, die die Festlegungen von ISO 11608 1 erfüllen.
Die Norm gilt nicht für
-   Kanülen zum zahnärztlichen Gebrauch;
-   Kanülen von vorgefüllten Spritzen;
-   Kanülen, die durch den Hersteller vormontiert sind;
-   Kanülen, die keine Montage oder Befestigung am NIS erfordern.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 2: Aiguilles (ISO 11608-2:2012)

L'ISO 11608-2:2012 spécifie les exigences et les méthodes d'essai des aiguilles stériles à deux extrémités à usage unique pour les systèmes d'injection à aiguille qui sont conformes aux spécifications de l'ISO 11608‑1.

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 2. del: Igle (ISO 11608-2:2012)

Ta del standarda ISO 11608 določa zahteve in preskusne metode za dvojne sterilne igle za enkratno uporabo za peresa za injiciranje (NIS), ki izpolnjujejo specifikacije standarda ISO 11608-1. Ne velja za: – igle za zobozdravniško uporabo; – igle z napolnjeno brizgo; – igle, ki jih sestavi proizvajalec; – igle, ki jih ni potrebno sestaviti ali namestiti na pero za injiciranje.

General Information

• Status: Withdrawn
• Publication Date: 31-Mar-2012
• Withdrawal Date: 03-May-2022
• 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
• Completion Date: 04-May-2022
• Ref Project: SIST EN ISO 11608-2:2012 - Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)

Relations

• Replaces: EN ISO 11608-2:2000 - Pen-injectors for medical use - Part 2: Needles - Requirements and test methods (ISO 11608-2:2000)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 11608-2:2022 - Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
• Effective Date: 11-May-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2012
1DGRPHãþD
SIST EN ISO 11608-2:2001
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 2. del:
Igle (ISO 11608-2:2012)
Needle-based injection systems for medical use - Requirements and test methods - Part
2: Needles (ISO 11608-2:2012)
Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 2: Nadeln (ISO 11608-2:2012)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 2: Aiguilles (ISO 11608-2:2012)
Ta slovenski standard je istoveten z: EN ISO 11608-2:2012
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 11608-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2012
ICS 11.040.25 Supersedes EN ISO 11608-2:2000
English Version
Needle-based injection systems for medical use - Requirements
and test methods - Part 2: Needles (ISO 11608-2:2012)
Systèmes d'injection à aiguille pour usage médical - Nadelbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 2: Aiguilles (ISO Verwendung - Anforderungen und Prüfverfahren - Teil 2:
11608-2:2012) Nadeln (ISO 11608-2:2012)
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 11608-2:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (EN ISO 11608-2:2012) 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 11608-2:2000.
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 11608-2:2012 has been approved by CEN as a EN ISO 11608-2:2012 without any
modification.
INTERNATIONAL ISO
STANDARD 11608-2
Second edition
2012-04-01
Needle-based injection systems for medical
use — Requirements and test methods —
Part 2:
Needles
Systèmes d’injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 2: Aiguilles
Reference number
ISO 11608-2:2012(E)
©
ISO 2012
ISO 11608-2:2012(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
Fax + 41 22 749 09 47
E-mail [e-mail]
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Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 11608-2:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Materials . 3
4.2 Dimensions . 3
4.3 Determination of flow rate through the needle. 3
4.4 Bond between hub and needle tube . 3
4.5 Needle points . 4
4.6 Freedom from defects . 4
4.7 Lubrication . 4
4.8 Dislocation of measuring point at patient end . 4
4.9 Determination of functional compatibility with needle-based injection systems . 4
4.10 Ease of assembly and disassembly . 4
4.11 Sterility . 4
5 Sampling . 4
6 Pre-conditioning of needles . 5
6.1 Pre-conditioning in a dry-heat atmosphere . 5
6.2 Pre-conditioning in a cold-storage atmosphere . 5
6.3 Pre-conditioning in a cyclical atmosphere . 5
7 Standard atmosphere and apparatus for tests . 6
7.1 General . 6
7.2 Standard test atmosphere . 6
7.3 Test gauge . 6
8 Determination of dislocation of measuring point at patient end . 7
9 Bond between hub and needle tube . 8
10 Packaging . 8
11 Test method for validating the compatibility of needles and injector systems . 8
11.1 Principle . 8
11.2 Apparatus and equipment . 9
11.3 Sample quantity requirements . 9
11.4 Procedure . 9
11.5 Acceptance criteria . 11
11.6 Test report .12
12 Information supplied by the manufacturer .12
12.1 General .12
12.2 Marking .12
12.3 Instructions for use .14
Annex A (normative) Determination of flow rate through needle .15
Bibliography .17
ISO 11608-2:2012(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 11608-2 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.
This second edition cancels and replaces the first edition (ISO 11608-2:2000), which has been technically revised.
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
...