1、BSI Standards PublicationBS ISO 17966:2016Assistive products for personalhygiene that support users Requirements and testmethodsBS ISO 17966:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 17966:2016. The UK participation in its preparation was entrusted t
2、o Technical Committee CH/173, Assistive products for persons with disability.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correc
3、t application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 77618 2 ICS 11.180.01; 11.180.99 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Polic
4、y and Strategy Committee on 31 January 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 17966:2016 ISO 2016Assistive products for personal hygiene that support users Requirements and test methodsProduits dassistance pour lhygine personnelle soutenant les utilisat
5、eurs Exigences et mthodes dessaiINTERNATIONAL STANDARDISO17966First edition2016-01-15Reference numberISO 17966:2016(E)BS ISO 17966:2016ISO 17966:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no pa
6、rt 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 ISOs member b
7、ody in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 17966:2016ISO 17966:2016(E)Foreword viiIntroduction viii1 Scope . 12 Normative references 23 Terms and defi
8、nitions . 34 General requirements and test methods 64.1 Risk analysis 64.2 Intended performance 64.3 Clinical evaluation and investigation . 64.4 Assistive products for personal hygiene that can be dismantled 64.5 Fasteners 74.6 Means to prevent falling out 74.7 User mass/load limits . 74.8 Apparatu
9、s 74.9 Test conditions . 175 Materials 185.1 General 185.2 Flammability 185.2.1 General. 185.2.2 Moulded parts used as enclosures for electrical equipment 185.2.3 Upholstered parts and moulded parts .185.3 Biocompatibility and toxicity 185.4 Infection and microbiological contamination .195.4.1 Clean
10、ing and disinfection 195.4.2 Resistance against temperature alternations 195.4.3 Animal tissue 195.5 Resistance to corrosion 196 Emitted sound and vibration 196.1 Noise and vibration 196.2 Sound pressure levels and frequencies of audible warning devices .207 Electromagnetic compatibility .207.1 Gene
11、ral 207.2 Emissions 207.3 Immunity. 207.4 Power frequency magnetic field immunity . 208 Electrical safety .218.1 General 218.2 Electrical systems 218.3 Safe positioning . 218.4 Single fault safety . 218.5 Hold to run activation 218.6 Emergency stopping functions. 218.7 Continuity of power supply . 2
12、28.8 Battery powered assistive products for personal hygiene .238.8.1 Battery housings .238.8.2 Connection . 238.8.3 Charge level indicator .238.9 Circuit protection . 238.10 Electrically heated blankets, pads and similar flexible heating appliances 248.11 Ingress of liquids 249 Overflow, leakage, a
13、nd ingress of liquids .24 ISO 2016 All rights reserved iiiContents PageBS ISO 17966:2016ISO 17966:2016(E)9.1 Ingress of liquids 249.1.1 Requirements 249.1.2 Test method . 249.2 Overflow and leakage . 249.2.1 General. 249.2.2 Substances which may leak from an APPH in intended use and in fault conditi
14、ons.2510 Temperatures of parts that come in contact with human skin .2511 Safety of moving and folding parts .2611.1 Squeezing 2611.2 Velocity of powered lifting and lowering movements .2711.2.1 Requirements 2711.2.2 Test method . 2711.3 Mechanical wear . 2711.4 Trapping zones for feet in relation t
15、o moving parts 2712 Prevention of traps for parts of the human body 2812.1 Holes and clearances 2812.2 V-shaped openings 2913 Folding and adjusting mechanisms 2913.1 General 2913.2 Locking mechanisms . 2914 Lifting and carrying means .3014.1 General 3014.2 Requirement 3014.3 Test method 3015 Portabl
16、e and hand-held products for personal hygiene or hand-held parts 3116 Static strength, impact and durability 3216.1 General 3216.2 Formulae . 3216.2.1 Formulae for calculating forces 3216.3 Number of test cycles for durability 3316.4 Static strength of lying support, arm and foot supports and seat a
17、nd back surfaces .3316.4.1 Requirements 3316.4.2 Test methods 3416.5 Durability 4016.5.1 Requirements 4016.5.2 Test methods 4116.6 Impact 4616.6.1 Requirements 4616.6.2 Test methods 4617 Stability .4917.1 Requirements for static stability 4917.2 Test method for static stability 4918 Surfaces, corner
18、s, edges and protruding parts 5019 Small parts .5020 Forces in soft tissues of the human body 5021 Ergonomic principles .5022 Mobile APPHs 5122.1 General 5122.2 Immobilizing means 5122.2.1 General. 5122.2.2 Requirements for locking devices 51iv ISO 2016 All rights reservedBS ISO 17966:2016ISO 17966:
19、2016(E)22.2.3 Test methods for locking devices . 5222.2.4 Test methods for durability of brakes 5222.2.5 Brake operated by a lever . 5222.3 Electrical safety for mobile APPHs . 5222.3.1 Power-driven mobile APPHs 5222.4 Rough handling and movement . 5222.4.1 General. 5222.4.2 Requirements 5222.4.3 Te
20、st method for movement over a threshold .5322.4.4 Test method for door frame shock 5322.5 Functional requirements for mobile APPHs . 5322.5.1 Foot supports .5322.5.2 Position of push handles/points .5322.5.3 Turning diameter of mobile APPHs 5322.6 Moving forces 5422.6.1 Requirements for moving force
21、s . 5422.6.2 Test methods for moving forces. 5423 Fixed APPHs 5523.1 General 5523.2 Requirements 5523.3 Shower seats (09 33 03) 5623.3.1 Description .5623.3.2 Test methods for static strength, durability and impact for shower seats .5623.4 Bathing stretchers, shower tables and diaper changing tables
22、 (09 33 12) .5723.4.1 Description .5723.4.2 Test methods for static strength and durability for bathing stretchers, shower tables and diaper changing tables .5723.5 Bath/shower chairs (without wheels), bath boards, stools, back supports and seats (09 33 03) 5823.5.1 Description .5823.5.2 Test method
23、 for durability 5823.6 Raised toilet seats (09 12 18) 5923.6.1 Description .5923.6.2 Requirements for static strength for raised toilet seats .5923.6.3 Test methods for static strength and durability for raised toilet seats 5923.7 Handrails, grab bars and handgrips (18 18 03 and 18 18 06) 6023.7.1 D
24、escription .6023.7.2 Ergonomic principles for handrails, grab bars and handgrips .6023.7.3 Test methods for static strength and durability for handrails, grab bars and handgrips 6123.8 Removable grab rails and handgrips (18 18 10) 6223.8.1 Description .6223.8.2 Ergonomic principles for removable gra
25、b rails and handgrips 6223.8.3 Test methods for static strength and durability for removable grab rails and handgrips 6223.9 Hinged rails and arm supports (18 18 11) 6323.9.1 Description .6323.9.2 General. 6323.9.3 Test method for static strength for hinged rails and arm supports 6323.10 Height-adju
26、stable plinths and brackets (18 15 06) .6423.10.1 Description .6423.10.2 Test methods for static strength and durability for height-adjustable plinths and brackets .6424 Static APPHs .6524.1 General 6524.2 Stability and strength tests for static APPHs . 6524.3 Toilet seats inserts (non fixed) (09 12
27、 15). 65 ISO 2016 All rights reserved vBS ISO 17966:2016ISO 17966:2016(E)24.3.1 Description .6524.3.2 Impact 6524.4 Toilet seats with built-in raising mechanism to help standing up and sitting down (non-fixed) (09 12 21) . 6824.4.1 Description .6824.4.2 Durability 6824.5 Bath/shower chairs (without
28、wheels), bath boards, stools, back supports and seats (09 33 03) 6824.5.1 Description .6824.5.2 Materials 6824.5.3 Stability . 6824.5.4 Stability tests for APPHs designed to be supported by the sides of a bathtub 6824.5.5 Strength test of brackets 7324.5.6 Friction test of bath board/seat .7624.5.7
29、Static horizontal force test on handle .7724.5.8 Static vertical force test of handle of bath and transfer boards .7725 Requirements for information supplied by the manufacturer .7825.1 General 7825.2 Instructions for use 7825.2.1 Pre-sale information 7825.2.2 User information .7925.2.3 Service info
30、rmation 8025.3 Labelling 8026 Packaging 8027 Test report 81Annex A (informative) Cognitive impairment 82Annex B (informative) General recommendations .83Annex C (informative) Environmental and consumer-related requirements 90Annex D (informative) Periodic inspection 95Bibliography .96vi ISO 2016 All
31、 rights reservedBS ISO 17966:2016ISO 17966:2016(E)ForewordISO (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
32、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
33、 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 ty
34、pes 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
35、 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 informa
36、tion given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the
37、following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 173, Assistive products for persons with disability. ISO 2016 All rights reserved viiBS ISO 17966:2016ISO 17966:2016(E)IntroductionThis International Standard specifies requirements and test meth
38、ods that are relevant to assistive products for personal hygiene that support users in home care, institutions and public places. Some of the devices can be used in more than one environment. This means that different requirements and test methods can be applied to the same product depending on the
39、environment. Clauses 1 to 21 and Clause 25 contain general requirements for all types of products included in the Scope. Clauses 22 to 24 contain specific requirements for mobile, fixed and static products. These clauses indicate additional requirements to the general clauses. In order for a product
40、 to claim compliance with this International Standard, all relevant clauses need to be fulfilled, depending on the type of product. For example, some products do not include electrical components; therefore, the clauses related to electrical components may not be relevant.In addition to the requirem
41、ents in this International Standard, Annex B gives general recommendations.viii ISO 2016 All rights reservedBS ISO 17966:2016Assistive products for personal hygiene that support users Requirements and test methods1 ScopeThis International Standard specifies requirements and associated test methods f
42、or assistive products for personal hygiene (APPHs) that support users and which are intended by the manufacturer to alleviate or compensate for disability. The work environment and safety aspects for assistants are also included. It specifies safety and performance requirements that apply during nor
43、mal use and foreseeable misuse and failure. It also specifies methods of measurement of the forces necessary to operate controls and specifies limits on the forces needed for some operations.This International Standard specifies requirements and test methods for assistive products within the followi
44、ng divisions of ISO 9999:2011:09 12 03 Commode chairs;NOTE This covers mobile and static products.09 12 06 Toilets with built in raising and height adjustable mechanism;NOTE This excludes toilets with built-in douche and air dryers.09 12 09 Toilet seats;09 12 12 Raised toilet seats mounted on frame;
45、09 12 15 Toilet seats inserts;09 12 18 Raised toilet seats fixed to toilet;09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down;09 12 24 Toilet arm supports and toilet back supports mounted on toilet;09 12 25 Toilet arm supports and toilet back supports, free st
46、anding;09 12 36 Douches and air dryers for attachment to a toilet;09 33 03 Bath/shower chairs (with and without wheels), bath boards, stools, back supports and seats;09 33 12 Bathing stretchers, shower tables and diaper-changing tables;18 15 06 Height adjustable plinths and brackets;NOTE Refers to h
47、eight adjustable plinths and brackets when used as an assistive product for personal hygiene (APPH). Height adjustable mechanisms for other items such as basins may be included.18 18 03 Handrails and support rails;18 18 06 Fixed grab bars and handgrips;18 18 10 Removable grab rails and handgrips;NOT
48、E This excludes removable grab rails and handgrips which are static as defined in 3.27.18 18 11 Hinged rails and arm supports;INTERNATIONAL STANDARD ISO 17966:2016(E) ISO 2016 All rights reserved 1BS ISO 17966:2016ISO 17966:2016(E)This International Standard does not encompass requirements regarding
49、: safe mounting in building structures; requirements regarding fixed building installations e.g. water and electricity; bathtub hoists that are covered by ISO 10535; 09 33 21 Bathtubs of ISO 9999:2011; stability and friction issues in relation to slippery surfaces due to soap; products that have been customised or custom-made for an individual user.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the
