SIST EN ISO 23908:2025

SLOVENSKI STANDARD
01-oktober-2025
Nadomešča:
SIST EN ISO 23908:2013
Zaščita pred poškodbami z ostrimi predmeti - Mehanizmi za zaščito pri uporabi
podkožnih igel za enkratno uporabo, nastavkov za uvedbo katetra in igel za
odvzem krvi, spremljanje, vzorčenje in apliciranje zdravil - Zahteve in preskusne
metode (ISO 23908:2024)
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 23908:2024)
Schutz vor Stich- und Schnittverletzung - Anforderungen und Prüfverfahren -
Schutzmechanismen für einmalig zu verwendende Kanülen, Einführhilfen für Katheter
und Kanülen für Bluttests, Überwachung, Probenahme und Verabreichung medizinischer
Substanzen (ISO 23908:2024)
Protection contre les blessures par perforants - Exigences et méthodes d’essai -
Mécanismes de protection des aiguilles à usage unique, des introducteurs pour
cathéters et des aiguilles utilisées pour les prélèvements sanguins, le contrôle,
l’échantillonnage et l’administration de substances médicales (ISO 23908:2024)
Ta slovenski standard je istoveten z: EN ISO 23908:2025
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.

EN ISO 23908
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 23908:2013
English Version
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 23908:2024)
Protection contre les blessures par perforants - Schutz vor Stich- und Schnittverletzung -
Mécanismes de protection des aiguilles à usage unique, Anforderungen und Prüfverfahren -
des introducteurs pour cathéters et des aiguilles Schutzmechanismen für einmalig zu verwendende
utilisées pour les prélèvements, le contrôle et Kanülen, Einführhilfen für Katheter und Kanülen für
l'échantillonnage sanguins et l'administration de Bluttests, Überwachung, Probenahme und
substances médicales - Exigences et méthodes d'essai Verabreichung medizinischer Substanzen (ISO
(ISO 23908:2024) 23908:2024)
This European Standard was approved by CEN on 12 December 2024.

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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23908:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
European foreword
This document (EN ISO 23908:2025) 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 February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 23908:2013.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 23908:2024 has been approved by CEN as EN ISO 23908:2025 without any modification.

Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative 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 General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation
(EU) 2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard
in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail. In this context, the definition of ‘device’ in EN ISO 23908 is limited to products in the
scope of the standard and differs from the definition of ‘medical device’ in Regulation (EU) 2017/745.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 This Annex ZA is based on normative references according to the table of references in Table ZA.2,
replacing the references in the core text.
NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117]
General Safety and Clause(s) / subclause(s) Remarks / Notes
Performance Requirements of of this EN
Regulation (EU) 2017/745
4a) 5.1.3, 5.1.4, 5.1.5, 5.1.6, 5.2, 5.3. Covered. Intent of these clauses
is to provide adequate level of
4b)
user safety through safe design.
4c)
Activation/safe mode is required
to be communicated to the user
in a clear and unmistakable
manner at least by a persistent
visual indication. Reference is
included to precautions,
warnings and training needs.
There are no foreseen
contraindications.
5 5.1.2, 5.1.3, 5.1.4, 5.1.5, 5.1.6, Covered with respect to
5.1.7 reducing risks related to
ergonomic features and the
environment in which the device
is intended to be used, giving
consideration of intended users
(including homecare patients,
caregivers, lay persons and
disabled persons), by requiring
the application of an appropriate
usability engineering program.
8 5, 6, 7 Covered. Intent of these clauses
is to provide adequate level of
user safety except for the
following devices (excluded
from the scope) because their
SIPMs have been found to
adversely affect the usability and
can increase the risk for patients
versus the benefit of the
intended use of the device:
Devices for medication loading
and transfer, where blunt tip
design would be required.
Invasive products whose
intended use is to access small
spaces, particularly ear, nose
and throat and ophthalmic
procedures.
11.1 a) and b) 5.1.1, 5.1.2, 5.1.3, 5.1.4, 5.1.5, Covered provided that the SIPM
5.1.6, 5.2, 5.3 is integrated as part of the
device before use, including any
General Safety and Clause(s) / subclause(s) Remarks / Notes
Performance Requirements of of this EN
Regulation (EU) 2017/745
required pre-use assembly.
14.1 7.3 b) Covered with respect of
providing assembly instructions
in the instructions for use to
obtain a safe combination,
where applicable.
14.7 5.1.4, 6.3, 7.3 e) Covered in part. Subclause 5.1.4
requires the mechanism to
provide protection against
unintentional sharp injury until
safe disposal and 7.3e) requires
provision of instructions for safe
disposal of the actuated
protection mechanism. The
requirements for testing
formative or summative user
interface evaluations include
protection until safe disposal of
the sharp but specific test
procedures are not provided.
22.1 5.1.2, 5.2, 5.3, 7.1 Covered.
22.2 5, 6, 7 Covered provided that the SIPM
is integrated as part of the
device before use, including any
required pre-use assembly.
22.3 5.1.4, 5.1.6 In part. Warning if the device has
failed to perform as intended is
not covered.
23.1 first paragraph 7 Covered with respect to
identifying in the instructions
for use the correct devices and
SIPM and providing assembly
instructions to obtain a safe
combination, where applicable.
Table ZA.2 — Normative references from Clause 2 of this document and their corresponding
European publications
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO 14971:2019 ISO 14971:2019 Medical devices — EN ISO 14971:2019 +A11:2021
Application of risk
management to medical
devices
ISO 16269-6:2014 ISO 16269-6:2014 Statistical interpretation of /
data — Part 6:
Determination of statistical
tolerance intervals
IEC 62366-1: IEC 62366-1: Medical devices — Part 1: EN 62366-1:2015
2015+A1:2020 2015+A1:2020 Application of usability
engineering to medical
devices
ISO 11608-1:2022 ISO 11608-1:2022 Needle-based injection EN ISO 11608-1:2022
systems for medical use –
Requirements and test
methods – Part 1: Needle-
based injection systems
ISO 20417:2021 ISO 20417:2021 Medical devices — EN ISO 20417:2021
Information to be supplied
by the manufacturer
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
International
Standard
ISO 23908
Second edition
Sharps injury protection — Sharps
2024-12
protection mechanisms for
single-use needles, introducers
for catheters and needles used
for blood testing, monitoring,
...