EN ISO 23908:2013

Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)

ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection.
It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.

Schutz vor Stich- und Schnittverletzung - Anforderungen und Prüfverfahren - Schutzeinrichtungen für einmalig zu verwendende Kanülen zur subkutanen Injektion, Kathetereinführungen und Kanülen zur Blutentnahme (ISO 23908:2011)

Diese Internationale Norm gibt Anforderungen und Prüfverfahren an zur Bewertung der Leistungsparameter von aktiv oder passiv ausgeführten Schutzeinrichtungen vor Stich  und Schnittverletzung bei Medizinprodukten, die (scharfe) einmal verwendete Kanülen zur subkutanen Injektion, Kathetereinführungen sowie Lanzetten und andere Kanülen zur Blutentnahme umfassen. Die damit eingeschlossenen Einrichtungen zum Schutz vor Stich  und Schnittverletzung können in das Produkt integriert oder mit dem Produkt verbunden sein, um vor der Anwendung den Schutz vor Stich  und Schnittverletzung sicherzustellen.
Es werden keine Anforderungen für die Lagerung und Handhabung der Schutzvorrichtung vor der vorgesehenen Verwendung oder für das Medizinprodukt selbst vorgegeben.

Protection contre les blessures par perforants - Exigences et méthodes d'essai - Dispositifs de protection des aiguilles hypodermiques, des introducteurs pour cathéters et des aiguilles utilisées pour les prélèvements sanguins, non réutilisables (ISO 23908:2011)

L'ISO 23908:2011 donne les exigences et décrit les méthodes d'essai pour l'évaluation des paramètres de performance des dispositifs de protection contre les blessures par perforants des équipements médicaux, que ces dispositifs soient de conception active ou passive, et des équipements médicaux équipés d'aiguilles hypodermiques (pointues) non réutilisables, d'introducteurs de cathéters et lancettes, ainsi que d'autres aiguilles pour prélèvement sanguin. Les dispositifs de protection contre les blessures par perforants qu'elle couvre, peuvent être intégrés au dispositif ou combinés à ce dernier avant leur utilisation dans le but de mettre en place une protection contre les blessures par perforants.
Elle ne couvre pas les exigences de stockage et de manipulation du dispositif de protection contre les perforants avant son utilisation conforme à l'usage prévu et les exigences relatives au dispositif médical lui-même.

Zaščita pred poškodbami z ostrimi predmeti - Zahteve in preskusne metode - Zaščitni ukrepi pri uporabi podkožnih igel za enkratno uporabo, nastavkov za uvedbo katetra in igel za odvzem krvi (ISO 23908:2011)

Ta mednarodni standard podaja zahteve in preskusne metode za ocenjevanje parametrov zmogljivosti ukrepov za zaščito pred poškodbami z ostrimi predmeti, ne glede na to, ali so po zasnovi aktivni ali pasivni, za medicinske pripomočke, ki vsebujejo (ostre) podkožne igle za enkratno uporabo, nastavke za uvedbo katetra in rezila ter druge igle za odvzem krvi. Pripomočki za zaščito pred poškodbami z ostrimi predmeti, ki so zajeti, so lahko dobavljeni vgrajeni v pripomoček ali pa jih je treba pred uporabo združiti s pripomočkom, da se zagotovi zaščita pred poškodbami z ostrimi predmeti. Ne podaja zahtev za shranjevanje in rokovanje z zaščito pred poškodbami z ostrimi predmeti pred njeno nameravano uporabo ali zahtev za sam medicinski pripomoček.

General Information

• Status: Published
• Publication Date: 05-Feb-2013
• Withdrawal Date: 30-Aug-2013
• ICS: 11.040.25 - Syringes, needles an catheters
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 06-Feb-2013
• Completion Date: 06-Feb-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 23908:2013 - Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)

Relations

• Replaces: EN ISO 23908:2011 - Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
• Effective Date: 30-Jan-2013
• Revised: FprEN ISO 23908 - Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods (ISO/FDIS 23908:2024)
• Effective Date: 17-Nov-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2013
1DGRPHãþD
SIST EN ISO 23908:2011
=DãþLWDSUHGSRãNRGEDPL]RVWULPLSUHGPHWL=DKWHYHLQSUHVNXVQHPHWRGH
=DãþLWQLXNUHSLSULXSRUDELSRGNRåQLKLJHO]DHQNUDWQRXSRUDERQDVWDYNRY]D
XYHGERNDWHWUDLQLJHO]DRGY]HPNUYL,62
Sharps injury protection - Requirements and test methods - Sharps protection features
for single-use hypodermic needles, introducers for catheters and needles used for blood
sampling (ISO 23908:2011)
Schutz vor Stich- und Schnittverletzung - Anforderungen und Prüfverfahren -
Schutzeinrichtungen für einmalig zu verwendende Nadeln zur subkutanen Injektion,
Kathetereinführungen und Nadeln zur Blutentnahme (ISO 23908:2011)
Protection contre les blessures par perforants - Exigences et méthodes d'essai -
Dispositifs de protection des aiguilles hypodermiques, des introducteurs pour cathéters
et des aiguilles utilisées pour les prélèvements sanguins, non réutilisables (ISO
23908:2011)
Ta slovenski standard je istoveten z: EN ISO 23908:2013
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 23908
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2013
ICS 11.040.25; 11.040.99 Supersedes EN ISO 23908:2011
English Version
Sharps injury protection - Requirements and test methods -
Sharps protection features for single-use hypodermic needles,
introducers for catheters and needles used for blood sampling
(ISO 23908:2011)
Protection contre les blessures par perforants - Exigences Schutz vor Stich- und Schnittverletzung - Anforderungen
et méthodes d'essai - Dispositifs de protection des aiguilles und Prüfverfahren - Schutzeinrichtungen für einmalig zu
hypodermiques, des introducteurs pour cathéters et des verwendende Nadeln zur subkutanen Injektion,
aiguilles utilisées pour les prélèvements sanguins, non Kathetereinführungen und Nadeln zur Blutentnahme (ISO
réutilisables (ISO 23908:2011) 23908:2011)
This European Standard was approved by CEN on 8 January 2013.

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
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23908:2013: 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 on Medical Devices . 4

Foreword
The text of ISO 23908:2011 has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and intravascular catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 23908:2013 by 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 August 2013, and conflicting national standards shall be withdrawn at
the latest by August 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 supersedes EN ISO 23908:2011.
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 23908:2011 has been approved by CEN as EN ISO 23908:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU 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 one 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.
NOTE This citation under the Directive 93/42/EEC is appropriate provided that the sharps protection is a feature
integrated/associated to the medical device.
Table ZA.1 — Correspondence between this European Standard and
Directive 93/42/EEC on Medical Devices
Clause(s)/subclause(s) Essential Requirements (ERs)
Qualifying remarks/Notes
of this European Standard of Directive 93/42/EEC
4.1.1.1, 4.1.1.2, 4.1.1.3, 4.3, 5.3, 5.4, 8.1
5.5
4.1.1.4 9.1
4.1.1.1, 4.1.1.2, 4.1.1.3, 4.3, 5.3, 5.4, 9.2
5.5
4.2, 5.2 12.7
6 13 The part of ER 13.3 a) relating to the
authorized representative and the part
of ER 13.6 h) relating to single-use are
not addressed in the standard.
WARNING — Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 23908
First edition
2011-06-11
Sharps injury protection — Requirements
and test methods — Sharps protection
features for single-use hypodermic
needles, introducers for catheters and
needles used for blood sampling
Protection contre les blessures par perforants — Exigences et
méthodes d'essai — Dispositifs de protection des aiguilles
hypodermiques, des introducteurs pour cathéters et des aiguilles
utilisées pour les prélèvements sanguins, non réutilisables

Reference number
ISO 23908:2011(E)
©
ISO 2011
ISO 23908:2011(E)
©  ISO 2011
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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Published in Switzerland
ii © ISO 2011 – All rights reserved

ISO 23908:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Requirements.2
4.1 General .2
4.2 Activation of the sharps injury protection feature.3
4.3 Security of safe mode protection .3
5 Test methods .3
5.1 General .3
5.2 Testing activation of a sharps injury protection feature .3
5.2.1 Principle.3
5.2.2 Apparatus.4
5.2.3 Procedure.4
5.3 Challenging the device in safe mode .5
5.3.1 General .5
5.3.2 Principle.5
5.3.3 Apparatus.5
5.3.4 Procedure.5
5.4 Testing access to the sharp in safe mode.6
5.5 Testing simulated clinical use .6
5.6 Test report.6
6 Information supplied by the manufacturer .6
6.1 General .6
6.2 Marking/labelling .7
6.3 Instructions for use .7
Annex A (informative) Guidance on simulated user studies.8
Annex B (informative) Method for testing access to the sharp in safe mode .10
Bibliography.11

ISO 23908:2011(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
adopt
...