ISO INTERNATIONAL STANDARD 15883-7 Firstedition 2016-02-01 Washer-disinfectors Part 7: Requirements and tests for washer- disinfectors employing chemical disinfection for non-invasive, non- critical thermolabile medical devices and healthcare equipment Laveurs déesinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la désinfection chimique pour les dispositifs medicaux et les équipements de soins thermosensibles non invasifs et non critiques Reference number ISO 15883-7:2016(E) ISO International Organization for Standardization @ IS0 2016 HEJIANG INST OF STANDARDIZATION C15956617 ed without license from IHS IS0 15883-7:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Internationai ibr DrganizationforStandardization icensee-ZHEJIANG INSTOF STANDARDIZAoIS 06 - All rights reserved networking permited without license from IHS Not for Resale, 2016/4/22 08:03:33 IS0 15883-7:2016(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope. 2 Normative references 3 Terms and definitions ..2 4 Performance requirements ..2 4.1 General .2 4.2 Cleaning. .3 4.3 Disinfection .3 4.4 .5 Final rinsing 4.5 Self-disinfection 5 4.6 Drying ..6 4.7 Water treatment equipment. .6 4.7.1 General ..6 4.7.2 Disinfection of water treatment equipment .6 4.7.3 Maintenance of piping. .7 5 Mechanical requirements. .7 5.1 Materials Design, manufacture, and assembly .7 5.2 Process verification.. .7 6 Testing for conformity .7 6.1 .7 General 6.2 Test load. ..8 6.2.1 Loading with standard goods 6.2.2 Loading with special goods ..8 6.3 Water used for rinsing following disinfection 6.4 Load dryness. ..8 6.4.1 General. ..8 6.4.2 Procedure. ..8 6.4.3 Results. .8 6.5 Thermometric tests 8 6.5.1 General. .8 6.5.2 Load temperature test .8 6.6 Chemical dosing tests. .9 6.6.1 General. 6.6.2 Reused process chemicals 9 6.7 Tests of cleaning efficacy. .9 6.7.1 General .9 6.7.2 Materials .9 6.7.3 Procedure ..10 6.7.4 Results. .10 6.8 Test of disinfection efficacy.. ..10 6.8.1 General. .10 6.8.2 Preliminary tests on chemical disinfectants ..10 6.8.3 Self-disinfection tests.. .11 6.8.4 Chemical disinfection of the load ..12 7 Documentation 8 Information to be provided by the manufacturer ..12 9 Marking, labelling, and packaging ..13 10 Information to be requested from the purchaser by the manufacturer. ..13 Annex A (normative) Summary of test programmes ..14 Inteatinal oganzation @stS2016 - All rights reserved iii Licensee-ZHEJIANG INST OF STANDARDIZATION C1 5956617 ted without licensefrom IHS Not for Resale, 2016/4/22 08:03:33