ISO INTERNATIONAL STANDARD 17966 First edition 2016-01-15 Assistive products for personal hygiene that support users - Requirements and test methods Produits d'assistance pour I'hygiene personnelle soutenant les utilisateurs - Exigences et méthodes d'essai Reference number IS0 17966:2016(E) ISO International Organization for Standardization ZHEJIANG INST OF STANDARDIZATION C1 5956617 @IS02016 vided by IHS under I No reproduction or networking permitted without license from IHS IS0 17966:2016(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 Internatinai br DrganizationforStandardization Licensee-ZHEJIANG INST OF STANDARDIZAISQ 0d6 - All rights reserved HS und Not for Resale, 2016/3/29 02:54:26 networking permited without license from IHS IS0 17966:2016(E) Contents Page Foreword ..vi Introduction. ..vili 1 Scope. 2 Normative references 3 Terms and definitions 4 General requirements and test methods 4.1 Risk analysis .6 4.2 Intended performance.. ..6 4.3 Clinical evaluation and investigation. ..6 4.4 Assistive products for personal hygiene that can be dismantled 4.5 Fasteners 7 4.6 Means to prevent falling out. 4.7 User mass/load limits ..7 4.8 Apparatus ..7 4.9 Test conditions ..17 5 Materials. ..18 5.1 General ..18 5.2 Flammability ..18 5.2.1 General .18 5.2.2 Moulded parts used as enclosures for electrical equipment. 5.2.3 Upholstered parts and moulded parts ..18 5.3 Biocompatibility and toxicity ..18 5.4 Infection and microbiological contamination, .19 5.4.1 Cleaning and disinfection. .19 5.4.2 Resistance against temperature alternations ..19 5.4.3 Animaltissue ..19 5.5 Resistance to corrosion ..19 6 Emitted sound and vibration ..19 6.1 Noise and vibration. .19 6.2 Sound pressure levels and frequencies of audible warning devices ..20 7 Electromagnetic compatibility .20 7.1 General. .20 7.2 Emissions. 20 7.3 Immunity. 20 7.4 Power frequency magnetic field immunity .20 8 Electrical safety .21 8.1 General. 21 8.2 Electrical systems 21 8.3 Safe positioning. 21 8.4 Single fault safety 21 8.5 Hold to run activation 21 8.6 Emergency stopping functions. 21 8.7 Continuity of power supply. 22 8.8 Battery powered assistive products for personal hygiene 23 8.8.1 Battery housings. 23 8.8.2 Connection. 23 8.8.3 Charge level indicator.. 23 8.9 Circuitprotection 23 8.10 Electrically heated blankets, pads and similar flexible heating appliances .24 8.11 Ingress of liquids. ..24 9 Overflow, leakage, and ingress of liquids ..24 iii Licensee-ZHEJIANG INST OF STANDARDIZATION C1 5956617 ted without license from IHS IS0 17966:2016(E) 9.1 Ingress of liquids. 24 9.1.1 Requirements 24 9.1.2 Test method. 24 9.2 Overflow and leakage.. 24 9.2.1 General. 24 9.2.2 Substances which may leak from an APPH in intended use and in fault conditions.. 25 10 Temperaturesofpartsthatcomein contact withhumanskin 25 11 Safety of moving and folding parts. .26 11.1 Squeezing 26 11.2 Velocity of powered lifting and lowering movements 27 11.2.1Requirements. .27 11.2.2 Test method. 27 11.3 Mechanical wear .27 11.4 Trapping zones for feet in relation to moving parts 27 12 Prevention of traps for parts of the human body .28 12.1 Holes and clearances 28 12.2 V-shaped openings. 29 13 Folding and adjusting mechanisms. 29 13.1 General. 29 13.2 Locking mechanisms. 29 14 Lifting and carrying means. .30 14.1 General. 30 14.2 Requirement 30 14.3 Test method. 30 15 Portable and hand-held products for personal hygiene or hand-