ISO INTERNATIONAL 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 catheéters et des aiguilles utiliseespourlesprelevementssanguins,nonreutilisables Reference number ISO 23908:2011(E) @ISO 2011 by IHS under ted without license from IHS Not for Resale ISO 23908:2011(E) COPYRIGHTPROTECTEDDOCUMENT @ ISO2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, 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 [email protected] Web www.iso.org Published in Switzerland @ ISO 2011 - All rights reserved py IHS unde Not for Resale ISO 23908:2011(E) Contents Page Foreword Introduction 1 Scope 2 Normative references. 3 Terms and definitions 4 Requirements. 4.1 General .... 4.2 Activation of the sharps injury protection feature. 4.3 Securityofsafemodeprotection....... 5 Test methods 5.1 General 5.2 Testing activation of a sharps injury protection feature 5.2.1 Principle... 5.2.2 Apparatus. 5.2.3 Procedure.. 5.3 Challenging the device in safe mode ... 5.3.1 General 5.3.2 Principle. 5.3.3 Apparatus.. 5.3.4 Procedure.. 5.4 5.5 Testing simulated clinical use ... 5.6 Test report... 6 Information supplied by the manufacturer.... 6.1 6.2 Marking/labelling ... 6.3 Instructions for use... Annex A (informative) Guidance on simulated user studies... Annex B (informative) Method for testing access to the sharp in safe mode ... 10 Bibliography.. Copyrght International OrganizaionStandardizalonghts reserved ii Not for Resale