SIST EN ISO 23908:2013

SLOVENSKI STANDARD
SIST EN ISO 23908:2013
01-maj-2013
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SIST EN ISO 23908:2011
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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
SIST EN ISO 23908:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23908:2013

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SIST EN ISO 23908:2013


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.

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SIST EN ISO 23908:2013
EN ISO 23908:2013 (E)
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


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SIST EN ISO 23908:2013
EN ISO 23908:2013 (E)
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.
3

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SIST EN ISO 23908:2013
EN ISO 23908:2013 (E)
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.


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SIST EN ISO 23908:2013

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

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SIST EN ISO 23908:2013
ISO 23908:2011(E)

COPYRIGHT PROTECTED DOCUMENT


©  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
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

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SIST EN ISO 23908:2013
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 2011 – All rights reserved iii

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SIST EN ISO 23908:2013
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
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 23908 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.
iv © ISO 2011 – All rights reserved

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SIST EN ISO 23908:2013
ISO 23908:2011(E)
Introduction
This International Standard addresses sharps injury protection systems designed to protect users of medical
devices. These sharps injury protection features are intended to prevent, or reduce the potential for, disease
transmission which could result from accidental, post-use sharps injuries.
This International Standard is aimed at addressing devices primarily intended for human use, of a wide range
of product types, including, among others, hollow-bore needles for injection or infusion of therapeutics into the
body, or sampling of fluids from the body, and hollow bore or solid-core needles used for blood sampling
(e.g. lancing devices). It addresses sharps injury protection systems which are either active or passive in their
activation after the medical device's intended use. It does not cover solid-core needles used for surgery
(e.g. suture needles).
Given the broad variation in product design and sharps protection technology, the variety of different types of
devices, and in order to avoid unnecessarily restricting innovation, this International Standard has been
developed as “horizontal” in nature, which means it provides for general design, testing and labelling
requirements, rather than specific physical and prescriptive design requirements. It therefore differs from more
“vertical” standards, which list specific maximum forces, detailed test fixture designs, test systems to be used
or detailed test measures, as such prescriptive details cannot cover the variety of designs and devices, and
may impede continuing innovation in new products, features and/or protection mechanisms that lead to future
improvements in healthcare.
This International Standard presumes that the product developer would use a risk-based approach (consistent
with ISO 14971) to determine the device design that best meets the needs of a target user population and
expected use settings. Through this risk-based approach, the sharps injury protection system would have
performance requirements appropriate to the foreseeable risks associated with the intended use of the device,
expected user interfaces, and the settings in which these safety features are expected to be used.
This International Standard provides guidelines to enable the manufacturer to verify that the design of the
sharps injury protection systems complies with the design intent spelled out in the design specification. As part
of this verification, the manufacturer is expected to demonstrate that the performance of the sharps injury
protection system is appropriate to the intended users and settings through the use of appropriate simulated
or clinical use studies. These simulated or clinical use studies allow the manufacturer to demonstrate that,
when used in accordance with the instructions for use, in settings representative of real-life intended use and
by intended or foreseeable users, the device functions as intended.
Existing products and those currently under development may not fulfil some of the requirements given by this
International Standard. However, manufacturers would be well advised to follow its provisions when improving
existing products or developing new products to obtain an even higher level of quality.

© ISO 2011 – All rights reserved v

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SIST EN ISO 23908:2013

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SIST EN ISO 23908:2013
INTERNATIONAL STANDARD ISO 23908:2011(E)

Sharps injury protection — Requirements and test methods —
Sharps protection features for single-use hypodermic needles,
introducers for catheters and needles used for blood sampling
1 Scope
This International Standard 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 2859 (all parts), Sampling procedures for inspection by attributes
ISO 3951 (all parts), Sampling procedures for inspection by variables
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 16269-6, Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
activation
deployment of the sharps protection mechanism
3.2
active safety feature
sharps protection feature that requires an additional step by the user to activate, separate from any action
needed to perform the primary intended function of the device
3.3
accidental sharps injury
unintentional penetration into human tissue by the sharp after the intended use
© ISO 2011 – All rights reserved 1

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SIST EN ISO 23908:2013
ISO 23908:2011(E)
3.4
passive safety feature
sharps protection feature that does not require an additional step by the user to activate, separate from any
action needed to perform the primary intended function of the device
3.5
safe mode
state of the device after activation of the safety feature
3.6
sharp
part of the device that can penetrate human tissue
3.7
sharps injury protection feature
feature that prevents accidental sharps injury
4 Requirements
4.1 General
4.1.1 Where the requirements do not specify forces for activation of the safety feature, the appropriate force
shall be determined
...