prEN ISO 23908

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

• Status: Not Published
• Publication Date: 05-May-2025
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 4060 - Closure of enquiry - Enquiry
• Start Date: 05-Jan-2024
• Completion Date: 05-Jan-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: oSIST prEN ISO 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)

Relations

• Revises: 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)
• Effective Date: 17-Nov-2021

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 23908:2023
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
oSIST prEN ISO 23908:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 23908:2023

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oSIST prEN ISO 23908:2023
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.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
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

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oSIST prEN ISO 23908:2023
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.
COPYRIGHT PROTECTED DOCUMENT
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.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
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
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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oSIST prEN ISO 23908:2023
ISO/DIS 23908:2023(E)
Contents Page
Foreword .
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