ISO 17966:2016

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
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
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

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ISO/FDIS 17966:2015(E)

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© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved

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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 2015 – All rights reserved iii

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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 .29
13.2 Locking mechanisms .29
14 Lifting and carrying means .29
14.1 General .29
14.2 Requirement .29
14.3 Test method .30
15 Portable and hand-held products for personal hygiene or hand-held parts .30
16 Static strength, impact and durability .31
16.1 General .31
16.2 Formulae .31
16.2.1 Formulae for calculating forces .31
16.3 Number of test cycles for durability .32
16.4 Static strength of lying support, arm and foot supports and seat and back surfaces .33
16.4.1 Requirements .33
16.4.2 Test methods .33
16.5 Durability .39
16.5.1 Requirements .39
16.5.2 Test methods .40
16.6 Impact .45
16.6.1 Requirements .45
16.6.2 Test methods .45
17 Stability .48
17.1 Requirements for static stability .48
17.2 Test method for static stability .48
18 Surfaces, corners, edges and protruding parts .49
19 Small parts .49
20 Forces in soft tissues of the human body .49
21 Ergonomic principles .49
22 Mobile APPHs .50
22.1 General .50
22.2 Immobilizing means .50
22.2.1 General.50
22.2.2 Requirements for locking devices .51
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ISO/FDIS 17966:2015(E)

22.2.3 Test methods for locking devices .51
22.2.4 Test methods for durability of brakes .51
22.2.5 Brake operated by a lever .51
22.3 Electrical safety for mobile APPHs .51
22.3.1 Power­driven mobile APPHs .51
22.4 Rough handling and movement . .51
22.4.1 General.51
22.4.2 Requirements .51
22.4.3 Test method for movement over a threshold .52
22.4.4 Test method for door frame shock .52
22.5 Functional requirements for mobile APPHs .52
22.5.1 Foot supports .52
22.5.2 Position of push handles/points .52
22.5.3 Turning diameter of mobile equipment .53
22.6 Moving forces .53
22.6.1 Requirements for moving forces .53
22.6.2 Test methods for moving forces.53
23 Fixed APPHs .54
23.1 General .54
23.2 Requirements .54
23.3 Shower seats (09 33 03) .55
23.3.1 Description . . .55
23.3.2 Test methods for static strength, durability and static strength for
shower seats .55
23.4 Bathing stretchers, shower tables and diaper changing tables (09 33 12) .56
23.4.1 Description . . .56
23.4.2 Test methods for static strength and durability for bathing stretchers,
shower tables and diaper changing tables .56
23.5 Bath/shower chairs (without wheels), bath boards, stools, back supports and
seats (09 33 03) .57
23.5.1 Description . . .57
23.5.2 Test method for durability .57
23.6 Raised toilet seats (09 12 18).58
23.6.1 Description . . .58
23.6.2 Requirements for static strength for raised toilet seats .58
23.6.3 Test methods for static strength and durability for raised toilet seats .58
23.7 Handrails, grab bars and handgrips (18 18 03 and 18 18 06) .59
23.7.1 Description . . .59
23.7.2 Ergonomic principles for handrails, grab bars and handgrips .59
23.7.3 Test methods for static strength and durability for handrails, grab bars
and handgrips . .60
23.8 Removable grab rails and handgrips (18 18 10) .61
23.8.1 Description . . .61
23.8.2 Ergonomic principles for removable grab rails and handgrips .61
23.8.3 Test methods for static strength and durability for removable grab rails
and handgrips . .61
23.9 Hinged rails and arm supports (18 18 11) .62
23.9.1 Description . . .62
23.9.2 General.62
23.9.3 Test method for static strength for hinged rails and arm supports .62
23.10 Height­adjustable plinths and brackets (18 15 06) .63
23.10.1 Description . . .63
23.10.2 Test methods for static strength and durability for height-adjustable
plinths and brackets . .63
24 Static APPHs .
...