ISO 17966:2016
(Main)Assistive products for personal hygiene that support users — Requirements and test methods
Assistive products for personal hygiene that support users — Requirements and test methods
ISO 17966:2016 specifies requirements and associated test methods for 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 normal 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 following 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; 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 standing; 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 height 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; NOTE This excludes removable grab rails and handgrips which are static as defined in 3.27. 18 18 11 Hinged rails and arm supports; ISO 17966:2016 does not encompass requirements regarding: - 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.
Produits d'assistance pour l'hygiène personnelle soutenant les utilisateurs — Exigences et méthodes d'essai
General Information
Standards Content (Sample)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 17966
ISO/TC 173
Assistive products for personal
Secretariat: SIS
hygiene that support users —
Voting begins
on: 201509-15 Requirements and test methods
Voting terminates
Produits d’assistance pour l’hygiène personnelle soutenant les
on: 20151115
utilisateurs — Exigences et méthodes d’essai
RECIPIENTS OF THIS DRAFT ARE INVITED TO
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OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 17966:2015(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2015
ISO/FDIS 17966:2015(E)
© ISO 2015, 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
CH1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
ISO/FDIS 17966:2015(E)
Contents Page
Foreword .vii
Introduction .viii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General requirements and test methods . 6
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 . 6
4.5 Fasteners . 7
4.6 Means to prevent falling out . 7
4.7 User mass/load limits . 7
4.8 Apparatus . 7
4.9 Test conditions .17
5 Materials .17
5.1 General .17
5.2 Flammability .18
5.2.1 General.18
5.2.2 Moulded parts used as enclosures for electrical equipment .18
5.2.3 Upholstered parts and moulded parts .18
5.3 Biocompatibility and toxicity .18
5.4 Infection and microbiological contamination .18
5.4.1 Cleaning and disinfection .18
5.4.2 Resistance against temperature alternations .19
5.4.3 Animal tissue .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 .19
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 .20
8.1 General .20
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 .22
8.8.1 Battery housings .22
8.8.2 Connection .23
8.8.3 Charge level indicator .23
8.9 Circuit protection .23
8.10 Electrically heated blankets, pads and similar flexible heating appliances .23
8.11 Ingress of liquids .23
9 Overflow, leakage, and ingress of liquids .24
ISO/FDIS 17966:2015(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.24
10 Temperatures of parts that come in contact with human skin .25
11 Safety of moving and folding parts .25
11.1 Squeezing .25
11.2 Velocity of powered lifting and lowering movements .26
11.2.1 Requirements .26
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 Vshaped openings .29
13 Folding and adjusting mechanisms .29
13.1 General .
...
INTERNATIONAL ISO
STANDARD 17966
First edition
2016-01-15
Assistive products for personal
hygiene that support users —
Requirements and test methods
Produits d’assistance pour l’hygiène personnelle soutenant les
utilisateurs — Exigences et méthodes d’essai
Reference number
©
ISO 2016
© ISO 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
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
Contents Page
Foreword .vii
Introduction .viii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General requirements and test methods . 6
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 . 6
4.5 Fasteners . 7
4.6 Means to prevent falling out . 7
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 .18
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 Animal tissue .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 Circuit protection .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
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 Temperatures of parts that come in contact with human skin .25
11 Safety of moving and folding parts .26
11.1 Squeezing .26
11.2 Velocity of powered lifting and lowering movements .27
11.2.1 Requirements .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 .
...
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