prEN ISO 23908
(Main)Sharps injury protection - Requirements and test methods - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration (ISO/DIS 23908:2023)
Sharps injury protection - Requirements and test methods - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration (ISO/DIS 23908:2023)
This document provides clear methods for performance-testing for sharps-injury protection mechanisms, whether active or passive in design, for medical devices containing single-used ‘sharps’ for administration and/or extraction of body/blood fluids and/or medicinal substances. Testing will confirm usability and elimination of exposure to, and risk of accidental injury from, contaminated ‘sharps’ during the period of intended use, including the paths to final disposal.
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/DIS 23908:2023)
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/DIS 23908:2023)
Zaščita pred poškodbami z ostrimi predmeti - Zahteve in preskusne metode - Mehanizmi za zaščito pri uporabi podkožnih igel za enkratno uporabo, nastavkov za uvedbo katetra in igel za odvzem krvi, spremljanje, vzorčenje in apliciranje zdravil (ISO/DIS 23908:2023)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2023
Zaščita pred poškodbami z ostrimi predmeti - Zahteve in preskusne metode -
Mehanizmi za zaščito pri uporabi podkožnih igel za enkratno uporabo, nastavkov
za uvedbo katetra in igel za odvzem krvi, spremljanje, vzorčenje in apliciranje
zdravil (ISO/DIS 23908:2023)
Sharps injury protection - Requirements and test methods - Sharps protection
mechanisms for single-use needles, introducers for catheters and needles used for blood
testing, monitoring, sampling and medical substance administration (ISO/DIS
23908:2023)
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/DIS 23908:2023)
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/DIS 23908:2023)
Ta slovenski standard je istoveten z: prEN ISO 23908
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.
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23908
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2023-10-13 2024-01-05
Sharps injury protection — Requirements and test
methods — Sharps protection mechanisms for single-use
needles, introducers for catheters and needles used for
blood testing, monitoring, sampling and medical substance
administration
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23908:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
ISO/DIS 23908:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23908
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
Sharps injury protection — Requirements and test
methods — Sharps protection mechanisms for single-use
needles, introducers for catheters and needles used for
blood testing, monitoring, sampling and medical substance
administration
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
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IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
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WHICH REFERENCE MAY BE MADE IN
Reference number
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 23908:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
ISO/DIS 23908:2023(E)
Contents Page
Foreword .iv
European foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms.3
5 Requirements . 4
5.1 General . 4
5.2 Activation of the sharps injury protection mechanism . 5
5.3 Security of safe mode protection . 5
6 Test methods . 5
6.1 General . 5
6.2 test procedure . 6
6.3 Testing activation of a sharps injury protection mechanism . 7
6.3.1 Principle . 7
6.3.2 Apparatus . 7
6.3.3 Procedure . 7
6.4 Challenging the SIPM in safe mode . 7
6.4.1 General . 7
6.4.2 Overriding/Unlocking test . 7
6.4.3 Resistance of the SIPM in safe mode to free fall . 8
6.5 Testing access to the sharp in safe mode . 9
7 Information supplied with the device . 9
7.1 General . 9
7.2 Marking/labelling . 9
7.3 Instructions for use . 9
Annex A (normative) Methods for testing access to the sharp in safe mode .11
Annex B (informative) Example of apparatus for performing the free fall test .14
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .16
Bibliography .19
iii
ISO/DIS 23908:2023(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee 84, Devices for administration of medicinal
products and catheters.
This second edition cancels and replaces the first edition (ISO 23908:2011), which has been technically
revised.
The main changes are as follows:
— Scope has been enlarged to single-use needles, introducers for catheters and needles used for blood
testing, monitoring, sampling and medical substance administration.
— Reliance on current medical devices standards: ISO 14971, IEC 62366-1, ISO 11608-1, ISO 20417.
— Addition of a falling test, with as a pass/fail the non-access to the sharps, in order to cover a frequent
misuse situation and avoid a potential increase of the risk of sharp injury.
— Updates on the test procedure to challenge the minimum overriding force of the SIPM in safe
mode in order to cover the numerous design possibilities (threshold is no greater than 20 % of the
specification interval for any given measurement, 30% for destructive test).
— For A-SIPM, misuse situations (obvious or non-obvious) shall be included in the risk assessment and
be mitigated as far as possible by product design.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DIS 23908:2023(E)
European foreword
This document (pr EN ISO 23908:2023) 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 na
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