Assistive products for walking manipulated by both arms -- Requirements and test methods

This document specifies requirements and test methods for walking frames used as assistive products for walking, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling. The requirements and tests are based on everyday use of walking frames as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes walking frames specified for a user mass of no less than 35Â kg.

Produits d’assistance à la marche manipulés avec les deux bras -- Exigences et méthodes d’essai

Le présent document spécifie les exigences et les méthodes d’essai applicables aux cadres de marche utilisés comme produits d’assistance à la marche manipulés par les deux bras, sans accessoires, sauf spécification contraire dans le mode opératoire d’essai particulier. Le présent document spécifie également les exigences en matière de sécurité, d’ergonomie et de performances ainsi que les informations fournies par le fabricant, incluant le marquage et l’étiquetage. Les exigences et essais reposent sur une utilisation quotidienne des cadres de marche en tant que produits d’assistance à la marche, pour une masse maximale de l’utilisateur telle que spécifiée par le fabricant. Le présent document inclut les cadres de marche spécifiés pour un poids d’utilisateur supérieur à 35 kg.

General Information

Status
Published
Publication Date
27-May-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
30-Mar-2021
Completion Date
29-Mar-2021
Ref Project

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INTERNATIONAL ISO
STANDARD 11199-1
Second edition
2021-05
Assistive products for walking
manipulated by both arms —
Requirements and test methods —
Part 1:
Walking frames
Produits d’assistance à la marche manipulés avec les deux bras —
Exigences et méthodes d’essai —
Partie 1: Cadres de marche
Reference number
ISO 11199-1:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 11199-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 11199-1:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Apparatus ..................................................................................................................................................................................................................... 6

5 Test conditions ....................................................................................................................................................................................................... 6

6 General requirements and test methods .................................................................................................................................... 7

6.1 Risk analysis .............................................................................................................................................................................................. 7

6.2 Walking frames that can be dismantled ............................................................................................................................ 8

6.3 Fasteners ...................................................................................................................................................................................................... 8

6.4 User mass/Load limits ..................................................................................................................................................................... 8

6.5 Structure requirements ................................................................................................................................................................... 8

6.6 Brakes ............................................................................................................................................................................................................. 8

6.6.1 Requirements .................................................................................................................................................................... 8

6.6.2 Test method .......................................................................................................................................................................... 9

6.7 Handgrip ....................................................................................................................................................................................................... 9

6.8 Leg section and tip ............................................................................................................................................................................... 9

7 Materials ....................................................................................................................................................................................................................... 9

7.1 General ........................................................................................................................................................................................................... 9

7.2 Flammability ..........................................................................................................................................................................................10

7.3 Biocompatibility and toxicity ..................................................................................................................................................10

7.4 Infection and microbiological contamination ...........................................................................................................10

7.4.1 General...................................................................................................................................................................................10

7.4.2 Cleaning and disinfection ......................................................................................................................................10

7.5 Resistance to corrosion ................................................................................................................................................................10

8 Ingress of liquids ...............................................................................................................................................................................................10

9 Temperatures of parts that come in contact with human skin .........................................................................11

10 Safety of moving parts .................................................................................................................................................................................11

10.1 Squeezing ..................................................................................................................................................................................................11

10.2 Mechanical wear .................................................................................................................................................................................12

11 Prevention of traps for parts of the human body ............................................................................................................12

11.1 Holes and clearances ......................................................................................................................................................................12

11.2 V-shape openings ...............................................................................................................................................................................12

12 Folding, adjusting and locking mechanisms .........................................................................................................................12

12.1 General ........................................................................................................................................................................................................12

12.2 Folding mechanisms ........................................................................................................................................................................13

12.3 Locking mechanisms .......................................................................................................................................................................13

13 Lifting and carrying handles .................................................................................................................................................................13

13.1 General ........................................................................................................................................................................................................13

13.2 Requirement ..........................................................................................................................................................................................13

13.3 Test method ............................................................................................................................................................................................14

14 Surfaces, corners and edges ..................................................................................................................................................................14

15 Static stability .......................................................................................................................................................................................................14

15.1 Requirements for static stability ..........................................................................................................................................14

15.2 Test method for static stability ..............................................................................................................................................15

15.2.1 General requirement .................................................................................................................................................15

15.2.2 Forward-direction static stability test ........................................................................................................15

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ISO 11199-1:2021(E)

15.2.3 Rearward-direction static stability test ....................................................................................................16

15.2.4 Sideway-direction static stability test ........................................................................................................17

16 Static strength ......................................................................................................................................................................................................18

16.1 Static strength of walking frame ...........................................................................................................................................18

16.1.1 General requirement .................................................................................................................................................18

16.1.2 Requirements for static strength of walking frame ........................................................................18

16.1.3 Test method for static strength of walking frame ............................................................................18

16.2 Static strength for the legs with tip ....................................................................................................................................19

16.2.1 General requirement .................................................................................................................................................19

16.2.2 Requirements for static strength of the legs with tip ....................................................................19

16.2.3 Test method for static strength of the legs with tip ........................................................................19

17 Durability test .......................................................................................................................................................................................................20

17.1 General requirement .......................................................................................................................................................................20

17.2 Requirement for durability .......................................................................................................................................................20

17.3 Test method for durability .........................................................................................................................................................20

18 Ergonomic principles ...................................................................................................................................................................................21

19 Packaging ..................................................................................................................................................................................................................21

20 Information supplied by the manufacturer ..........................................................................................................................21

20.1 General ........................................................................................................................................................................................................21

20.2 Information marked on the product .................................................................................................................................22

20.3 Instruction manual ...........................................................................................................................................................................22

20.4 Test report ................................................................................................................................................................................................23

Annex A (informative) Consideration items for hazards when designing the products ..............................25

Annex B (informative) General recommendations .............................................................................................................................27

Bibliography .............................................................................................................................................................................................................................29

iv © ISO 2021 – All rights reserved
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ISO 11199-1:2021(E)
Foreword

ISO (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 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 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 types 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 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 information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 173, Assistive products, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive

products and accessibility, in accordance with the Agreement on technical cooperation between ISO and

CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 11199-1:1999), which has been technically

revised.
The main changes compared to the previous edition are as follows:
— 3.1 was changed to be in accordance with ISO 9999;

— Clause 6, on general requirements for assistive products for walking, was added.

A list of all parts in the ISO 11199 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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ISO 11199-1:2021(E)
Introduction

A walking frame can be used when a person needs assistance when walking. The walking frame can

provide stability when walking and standing and reduce the risk of falling. Walking frames are designed

to support the user inside a frame to carry the user’s full body weight.
vi © ISO 2021 – All rights reserved
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INTERNATIONAL STANDARD ISO 11199-1:2021(E)
Assistive products for walking manipulated by both
arms — Requirements and test methods —
Part 1:
Walking frames
1 Scope

This document specifies requirements and test methods for walking frames used as assistive products

for walking, manipulated by both arms, without accessories, unless specified in the particular test

procedure. This document also gives requirements relating to safety, ergonomics, performance and

information supplied by the manufacturer, including marking and labelling.

The requirements and tests are based on everyday use of walking frames as assistive products for

walking for a maximum user mass as specified by the manufacturer. This document includes walking

frames specified for a user mass of no less than 35 kg.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 8191-2, Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source:

match-flame equivalent

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 13732-1, Ergonomics of the thermal environment — Methods for the assessment of human responses to

contact with surfaces — Part 1: Hot surfaces
ISO 14971, Medical devices — Application of risk management to medical devices

ISO 15223-1, Medical device – Symbols to be used with medical device labels, labelling and information to

be supplied – Part 1: General requirements
ISO 20417, Medical devices — Information to be supplied by the manufacturer

ISO 24415-1, Tips for assistive products for walking — Requirements and test methods — Part 1: Friction

of tips
ISO 7000, Graphical symbols for use on equipment — Registered symbols

EN 614-1+A1, Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
© ISO 2021 – All rights reserved 1
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ISO 11199-1:2021(E)
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
brake
device for slowing or stopping motion of a walking frame by contact friction
3.2
front handgrip reference point

position on the upper surface of the handgrip located 30 mm from the front end of the handgrip length

Note 1 to entry: See Figure 1.
3.3
handgrip

part of the walking frame that is intended by the manufacturer to be held by the hand when the walking

frame is in use
Note 1 to entry: See Figure 1.
Key
1 rear handgrip reference point 4 handgrip width
2 front handgrip reference point 5 front
3 handgrip length
Figure 1 — Details of a handgrip
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ISO 11199-1:2021(E)
3.4
handgrip length
dimension of the handgrip measured where the hand rests
Note 1 to entry: See Figure 1.

Note 2 to entry: Where the front end or the rear end of the handgrip is not clear, the full length of the handgrip

that can comfortably support the mass of the user is defined as the handgrip length.

3.5
handgrip width

outside dimension of the handgrip measured at the thickest point where the hand rests

Note 1 to entry: See Figure 1.
3.6
handle
part of the walking frame to which the handgrip is attached
3.7
maximum user mass

greatest permissible mass of the person using the product, measured in kilograms (kg)

Note 1 to entry: The maximum user mass is specified by the manufacturer of the walking frame.

3.8
maximum width

maximum outside dimension of a walking frame when the adjustments are at their maximum. measured

horizontally at right angles to the direction of movement when the walking frame is in normal use

Note 1 to entry: See Figure 3.
3.9
parking brake

brake system that is intended for keeping the walking frame stationary on ground after being activated

3.10
pressure brake

running brake that engages when a vertical load is applied on the handgrips or on supporting points of

the walking frame
Note 1 to entry: See Figure 2
Key
1 wheel 4 rubber tip (brake)
2 spring 5 brake pad
3 frame
Figure 2 — Two types of pressure brake with technical details
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ISO 11199-1:2021(E)
3.11
rear handgrip reference point

position on the upper surface of the handgrip located 30 mm from the rear end of the handgrip length

Note 1 to entry: See Figure 1.

Note 2 to entry: If the grip protrudes further than the handle, the measurement is made from the end of the

handle.
3.12
reciprocal walking frame

walking frame where each side of the frame moves alternately, allowing unilateral forward progression

through the whole gait cycle
3.13
running brake

brake that is operated by the user during walking and where the braking effect depends proportionally

on the activation force applied
3.14
tip
part of a walking frame that is in contact with the ground
3.15
turning diameter

diameter of the largest circle described by a walking frame when the adjustments are at their maximum

and walking frame is turned through 360° about its own central vertical axis
Note 1 to entry: See Figure 3.
Key
1 width between handles 4 turning diameter
2 height 5 length
3 width
Figure 3 — Dimensions of a walking frame
4 © ISO 2021 – All rights reserved
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ISO 11199-1:2021(E)
3.16
walking frame

frame that a person lifts to move, which enables to support full body weight and to maintain stability

and balance while walking or standing with hand grips, without forearm supports and with either four

tips or two tips and two castors/wheels
Note 1 to entry: See Figure 4.
Note 2 to entry: ISO 9999, Classification No. 12 06 03.

Note 3 to entry: Double or more castors/wheels used for one pivot position shall be counted as one castor/wheel.

The caster/wheel with a pressure brake shall be considered as the tip.

Note 4 to entry: Examples of walking frames include rigid or articulated walking frames assistive products for

walking with two wheels combination with two rubber stick buffers/tips.
Key
1 front 5 rear
2 front legs 6 rear legs
3 bracing members 7 head adjustment mechanism
4 handgrip 8 tips
Figure 4 — Example of walking frame
3.17
wheel width

maximum dimension of the tyre of the wheel measured within 5 mm up from the walking surface when

the walking frame is unloaded
Note 1 to entry: See Figure 5.
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ISO 11199-1:2021(E)
Key
1 tyre 3 wheel width
2 0 to 5 mm up from the walking surface
Figure 5 — Wheel width measurement
4 Apparatus

4.1 Means to apply a force with an accuracy of ±5 % and with a rate of application less than 1 N/s.

4.2 Means to measure force with an accuracy of ±5 % in increments of 1 N.

4.3 Means to measure distance in the range of 0 m to 3 m with an accuracy of ±5 mm or ±2 %,

whichever is the greater
4.4 Means to measure angles to an accuracy of ±0,5°.

4.5 Means to measure torque with an accuracy of ±5 % in increments of 1 Nm in the range of 0,5 Nm

to 10 Nm

4.6 A test plane of sufficient size and stiffness to support the walking frame during testing, such that

the whole surface is contained between two imaginary parallel planes 5 mm a part. The test plane can be

adjustable, or fixed.
NOTE 1 A wooden or steel frame with a plywood surface can be used.
NOTE 2 A test surface of 1,5 m x 2 m is usually of sufficient size.

4.7 Stoppers devices of sufficient height to prevent the walking frame from moving during testing,

without interfering with the test or the walking frame.
4.8 Equipment for measuring pressure of air with an accuracy of ±5 %
5 Test conditions
The following conditions shall be applied:
a) The tests shall be performed at an ambient temperature of 21 °C ± 5 °C.

b) Adjustable parts of the walking frame shall be adjusted to the most adverse position according to

manufacturer’s instruction unless otherwise specified in the test procedure.
6 © ISO 2021 – All rights reserved
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ISO 11199-1:2021(E)

c) The swivelling wheels shall be positioned as if the walking frame is run forward as far as a condition

is not specified in the test procedure.

d) The handles shall be positioned at their maximum distance and maximum angles to provide the

most adverse configuration as specified by the manufacturer as far as a condition is not specified

in the test procedure. When the longitudinal centreline of the handle and the direction of forward

motion are parallel, the angle is 0°. The angle shall always be recorded.

e) The running brake and parking brake shall not be operated as far as the test procedure does not

specify it.

f) All abnormalities such as breakage on each test shall be recorded and be distinguished from the

abnormalities on the subsequent tests.

g) During the stability tests, the walking frame shall be prevented from sliding or rolling before tilting

occurs. The results of the tests shall not be influenced by the means used. If the walking frame is

less stable with the height adjustment at a lower height, the least stable position shall be tested.

h) If the manufacturer offers alternative handle fittings as accessory equipment, all alternatives shall

be supplied with the walking frame when tested so that the walking frame can be tested in the

least favourable configuration (e.g. extended handles).

i) Before testing, the walking frame shall be inspected to check conformity with this document.

Any apparent defects shall be documented so that they shall not later be recorded as having been

caused by the tests.
j) A walking frame shall be tested in the following sequence:
— measurements;
— stability;
— brakes;
— handgrips;
— rubber tips;
— static strength of the walking frame;
— static strength of the legs;
— durability.
6 General requirements and test methods
6.1 Risk analysis

The safety of a walking frame shall be assessed by the manufacturer by identifying hazards and

estimating the risks associated with them using the procedures specified in ISO 14971. If relevant,

ISO 12100 can be used additionally.

When a walking frame is intended by the manufacturer to be used in combination with other devices,

the risks shall be assessed by the manufacturer.

NOTE 1 In the case of certain disabilities, there can be a need for higher levels of safety for equipment used to

offset the effects of that disability.
NOTE 2 For precise information on the hazard causes a risk, refer to Annex A.
© ISO 2021 – All rights reserved 7
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ISO 11199-1:2021(E)
6.2 Walking frames that can be dismantled
If it is intended
...

NORME ISO
INTERNATIONALE 11199-1
Deuxième édition
2021-05
Produits d’assistance à la marche
manipulés avec les deux bras —
Exigences et méthodes d’essai —
Partie 1:
Cadres de marche
Assistive products for walking manipulated by both arms —
Requirements and test methods —
Part 1: Walking frames
Numéro de référence
ISO 11199-1:2021(F)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 11199-1:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2021 – Tous droits réservés
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ISO 11199-1:2021(F)
Sommaire Page

Avant-propos ................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Appareillage .............................................................................................................................................................................................................. 7

5 Conditions d’essai ................................................................................................................................................................................................ 7

6 Exigences générales et méthodes d’essai ................................................................................................................................... 8

6.1 Analyse des risques ............................................................................................................................................................................. 8

6.2 Cadres de marche pouvant être démontés ..................................................................................................................... 9

6.3 Fixations ....................................................................................................................................................................................................... 9

6.4 Masse de l’utilisateur/limites de charge ........................................................................................................................... 9

6.5 Exigences de structure ..................................................................................................................................................................... 9

6.6 Freins ............................................................................................................................................................................................................10

6.6.1 Exigences .............................................................................................................................................................................10

6.6.2 Méthode d’essai .............................................................................................................................................................10

6.7 Poignée de préhension ..................................................................................................................................................................10

6.8 Section inférieure et embout ...................................................................................................................................................10

7 Matériaux ..................................................................................................................................................................................................................11

7.1 Généralités ...............................................................................................................................................................................................11

7.2 Inflammabilité ......................................................................................................................................................................................11

7.3 Biocompatibilité et toxicité .......................................................................................................................................................11

7.4 Infection et contamination microbiologique .............................................................................................................11

7.4.1 Généralités .........................................................................................................................................................................11

7.4.2 Nettoyage et désinfection ......................................................................................................................................11

7.5 Résistance à la corrosion .............................................................................................................................................................12

8 Pénétration de liquides ..............................................................................................................................................................................12

9 Températures des parties entrant en contact avec la peau humaine .........................................................12

10 Sécurité des parties mobiles .................................................................................................................................................................13

10.1 Écrasement ..............................................................................................................................................................................................13

10.2 Usure mécanique................................................................................................................................................................................13

11 Prévention des pièges pour certaines parties du corps humain .....................................................................13

11.1 Trous et espaces ..................................................................................................................................................................................13

11.2 Ouvertures en forme de V ...........................................................................................................................................................14

12 Mécanismes de pliage, de réglage et de verrouillage ..................................................................................................14

12.1 Généralités ...............................................................................................................................................................................................14

12.2 Mécanismes de pliage ....................................................................................................................................................................15

12.3 Mécanismes de verrouillage .....................................................................................................................................................15

13 Poignées de levage et de portage......................................................................................................................................................15

13.1 Généralités ...............................................................................................................................................................................................15

13.2 Exigences ..................................................................................................................................................................................................15

13.3 Méthode d’essai ...................................................................................................................................................................................16

14 Surfaces, angles et arêtes ..........................................................................................................................................................................16

15 Stabilité statique ................................................................................................................................................................................................17

15.1 Exigences en matière de stabilité statique...................................................................................................................17

15.2 Méthode d’essai de stabilité statique ...............................................................................................................................17

15.2.1 Exigence générale ........................................................................................................................................................17

15.2.2 Essai de stabilité statique vers l’avant .......................................................................................................17

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ISO 11199-1:2021(F)

15.2.3 Essai de stabilité statique vers l’arrière ....................................................................................................18

15.2.4 Essai de stabilité statique latérale .................................................................................................................19

16 Résistance statique .........................................................................................................................................................................................20

16.1 Résistance statique du cadre de marche .......................................................................................................................20

16.1.1 Exigence générale ........................................................................................................................................................20

16.1.2 Exigences relatives à la résistance statique du cadre de marche........................................20

16.1.3 Méthode d’essai de résistance statique du cadre de marche .................................................20

16.2 Résistance statique pour les pieds avec embout ....................................................................................................21

16.2.1 Exigence générale ........................................................................................................................................................21

16.2.2 Exigences pour la résistance statique des pieds avec embout ..............................................21

16.2.3 Méthodes d’essai pour la résistance statique des pieds avec embout ............................21

17 Essai de durabilité ...........................................................................................................................................................................................22

17.1 Exigence générale ..............................................................................................................................................................................22

17.2 Exigence relative à la durabilité ............................................................................................................................................22

17.3 Méthode d’essai concernant la durabilité .....................................................................................................................22

18 Principes d’ergonomie ................................................................................................................................................................................23

19 Emballage..................................................................................................................................................................................................................24

20 Informations fournies par le fabricant ......................................................................................................................................24

20.1 Généralités ...............................................................................................................................................................................................24

20.2 Marquage des informations sur le produit ..................................................................................................................24

20.3 Manuel d’instructions ....................................................................................................................................................................25

20.4 Rapport d’essai ....................................................................................................................................................................................26

Annexe A (informative) Éléments de danger à prendre en compte lors de la conception

des produits ............................................................................................................................................................................................................27

Annexe B (informative) Recommandations générales ...................................................................................................................29

Bibliographie ...........................................................................................................................................................................................................................31

iv © ISO 2021 – Tous droits réservés
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ISO 11199-1:2021(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www .iso .org/ avant -propos.

Le présent document a été élaboré par le comité technique ISO/TC 173, Appareils et accessoires

fonctionnels pour les personnes handicapées, en collaboration avec le comité technique CEN/TC 293, Aides

techniques pour personnes handicapées, du Comité européen de normalisation (CEN), conformément à

l’Accord de coopération technique entre l’ISO et le CEN (Accord de Vienne).

Cette deuxième édition annule et remplace la première edition (ISO 11199-1:1999), qui a fait l’objet

d’une révision technique.

Les principales modifications par rapport à l’édition précédente sont les suivantes:

— 3.1 a été modifié pour être conforme à l’ISO 9999;

— l’Article 6, sur les exigences générales relatives aux produits d’assistance à la marche, a été ajouté.

Une liste de toutes les parties de la série ISO 11199 se trouve sur le site web de l’ISO.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
© ISO 2021 – Tous droits réservés v
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ISO 11199-1:2021(F)
Introduction

Un cadre de marche peut être utilisé lorsqu’une personne a besoin d’une assistance pour marcher. Le

cadre de marche peut assurer la stabilité lors de la marche et de la station debout, de même que réduire

le risque de chute. Les cadres de marche sont conçus de sorte à soutenir l’utilisateur à l’intérieur d’un

cadre en supportant tout le poids de son corps.
vi © ISO 2021 – Tous droits réservés
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NORME INTERNATIONALE ISO 11199-1:2021(F)
Produits d’assistance à la marche manipulés avec les deux
bras — Exigences et méthodes d’essai —
Partie 1:
Cadres de marche
1 Domaine d’application

Le présent document spécifie les exigences et les méthodes d’essai applicables aux cadres de marche

utilisés comme produits d’assistance à la marche manipulés par les deux bras, sans accessoires, sauf

spécification contraire dans le mode opératoire d’essai particulier. Le présent document spécifie

également les exigences en matière de sécurité, d’ergonomie et de performances ainsi que les

informations fournies par le fabricant, incluant le marquage et l’étiquetage.

Les exigences et essais reposent sur une utilisation quotidienne des cadres de marche en tant que

produits d’assistance à la marche, pour une masse maximale de l’utilisateur telle que spécifiée par

le fabricant. Le présent document inclut les cadres de marche spécifiés pour un poids d’utilisateur

supérieur à 35 kg.
2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.

Pour les références non datées, la dernière édition du document de référence s'applique (y compris les

éventuels amendements).

ISO 8191-2, Ameublement — Évaluation de la facilité d'allumage des meubles rembourrés — Partie 2:

Source d'allumage: flamme simulant une allumette

ISO 10993-1, Évaluation biologique des dispositifs médicaux — Partie 1: Évaluation et essais au sein d'un

processus de gestion du risque

ISO 13732-1, Ergonomie des ambiances thermiques — Méthodes d'évaluation de la réponse humaine au

contact avec des surfaces — Partie 1: Surfaces chaudes

ISO 14971, Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux

ISO 15223-1, Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l’étiquetage et les informations

à fournir relatifs aux dispositifs médicaux — Partie 1: Exigences générales
ISO 20417, Dispositifs médicaux — Informations à fournir par le fabricant

ISO 24415-1, Embouts pour produits d'assistance à la marche — Exigences et méthodes d'essai — Partie 1:

Frottement des embouts
ISO 7000, Symboles graphiques utilisables sur le matériel — Symboles enregistrés

EN 614-1+A1, Sécurité des machines — Principes ergonomiques de conception — Partie 1: Terminologie et

principes généraux
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions suivants s’appliquent.

© ISO 2021 – Tous droits réservés 1
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ISO 11199-1:2021(F)

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
3.1
frein

dispositif permettant de ralentir ou d’arrêter le mouvement d’un cadre de marche par friction de contact

3.2
point de référence avant de la poignée de préhension

point situé sur la surface supérieure de la poignée de préhension, à une distance de 30 mm de l’extrémité

avant de la longueur de la poignée de préhension
Note 1 à l'article: Voir la Figure 1.
3.3
poignée de préhension

partie du cadre de marche prévue par le fabricant pour être tenue dans la main lors de l’utilisation du

cadre de marche
Note 1 à l'article: Voir la Figure 1.
2 © ISO 2021 – Tous droits réservés
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ISO 11199-1:2021(F)
Légende

1 point de référence arrière de la poignée de préhension 4 largeur de la poignée de préhension

2 point de référence avant de la poignée de préhension 5 avant
3 longueur de la poignée de préhension
Figure 1 — Représentation détaillée d’une poignée de préhension
3.4
longueur de la poignée de préhension
dimension de la poignée de préhension mesurée à l’endroit où la main repose
Note 1 à l'article: Voir la Figure 1.

Note 2 à l'article: Lorsque ni l’avant ni l’arrière de la poignée de préhension ne sont définis, la longueur totale

de la poignée de préhension pouvant supporter la masse de l’utilisateur doit être la longueur de la poignée de

préhension.
3.5
largeur de la poignée de préhension

dimension de la poignée de préhension mesurée au niveau de la plus forte épaisseur à l’emplacement où

repose la main
Note 1 à l'article: Voir la Figure 1.
© ISO 2021 – Tous droits réservés 3
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ISO 11199-1:2021(F)
3.6
poignée
partie du cadre de marche à laquelle la poignée de préhension est fixée
3.7
masse maximale de l’utilisateur

masse la plus élevée autorisée d’une personne utilisant le produit, mesurée en kilogrammes (kg)

Note 1 à l'article: La masse maximale de l’utilisateur est spécifiée par le fabricant du cadre de marche.

3.8
largeur maximale

dimension extérieure maximale d’un cadre de marche, mesurée sur le plan horizontal,

perpendiculairement au sens du mouvement d’utilisation normale du cadre de marche, lorsque les

réglages sont au maximum
Note 1 à l'article: Voir la Figure 3.
3.9
frein de stationnement

système de freinage destiné à maintenir le cadre de marche immobile au sol après son activation

3.10
frein par pression

frein de service qui s’enclenche lorsqu’une charge verticale est appliquée sur les poignées de préhension

ou sur certains points d’appui du cadre de marche
Note 1 à l'article: Voir la Figure 2.
Légende
1 roue 4 embout en caoutchouc (frein)
2 ressort 5 plaquette de frein
3 cadre
Figure 2 — Deux types de freins par pression avec détails techniques
3.11
point de référence arrière de la poignée de préhension

point situé sur la surface supérieure de la poignée de préhension, à une distance de 30 mm de l’extrémité

arrière de la longueur de la poignée de préhension
Note 1 à l'article: Voir la Figure 1.

Note 2 à l'article: Lorsque la poignée de préhension fait saillie par rapport à la poignée sur laquelle elle se trouve,

le mesurage doit être effectué à partir de l’extrémité de cette poignée.
4 © ISO 2021 – Tous droits réservés
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ISO 11199-1:2021(F)
3.12
cadre de marche articulé

cadre de marche dans lequel chaque côté du cadre se déplace alternativement, ce qui permet une

progression unilatérale vers l’avant tout au long du cycle de marche
3.13
frein de service

frein actionné par l’utilisateur en cours de marche et dont l’effet de freinage est proportionnel à la force

d’actionnement appliquée
3.14
embout
partie du cadre de marche qui se trouve en contact avec le sol
3.15
diamètre de giration

diamètre contenu dans le plus grand cercle décrit par un cadre de marche lorsque les réglages sont au

maximum et que le cadre de marche subit une rotation de 360° autour de son axe vertical

Note 1 à l'article: Voir la Figure 3.
Légende
1 largeur entre les poignées 4 diamètre de giration
2 hauteur 5 longueur
3 largeur
Figure 3 — Dimensions d’un cadre de marche
3.16
cadre de marche

cadre qu’une personne soulève pour se déplacer, qui permet de supporter le poids du corps entier

ainsi que de marcher et de se tenir debout en maintenant la stabilité et l’équilibre avec des poignées de

préhension, sans support d’avant-bras, et quatre embouts ou deux embouts et deux roulettes/roues

Note 1 à l'article: Voir la Figure 4.
© ISO 2021 – Tous droits réservés 5
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ISO 11199-1:2021(F)
Note 2 à l'article: ISO 9999, classification n° 12 06 03.

Note 3 à l'article: Les roulettes/roues doubles ou multiples utilisées comme position de pivot unique doivent être

comptées comme une seule roulette/roue. La roulette/roue avec frein par pression doit être considérée comme

l’extrémité.

Note 4 à l'article: Les cadres de marche rigides ou articulés et les produits d’assistance à la marche avec deux

roues et deux butées/embouts en caoutchouc en font partie, par exemple.
Légende
1 avant 5 arrière
2 pieds avant 6 pieds arrière
3 entretoises 7 dispositif de réglage de la hauteur
4 poignée de préhension 8 embouts
Figure 4 — Exemple de cadre de marche
3.17
largeur de roue

dimension maximale du pneu de la roue mesurée sur 5 mm, à partir de la surface de marche, le cadre de

marche n’étant pas sous charge
Note 1 à l'article: Voir la Figure 5.
6 © ISO 2021 – Tous droits réservés
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ISO 11199-1:2021(F)
Légende
1 pneu 3 largeur de roue
2 entre 0 mm et 5 mm à partir de la surface de marche
Figure 5 — Mesurage de la largeur de roue
4 Appareillage

4.1 Dispositif d’application d’une force, d’une exactitude de ± 5 % et une vitesse de mise en charge

inférieure à 1 N/s.

4.2 Dispositif de mesure de la force, d’une exactitude de ± 5 % et des paliers de réglage de 1 N.

4.3 Dispositif de mesure de la distance dans la plage de 0 mm à 3 m, avec une exactitude de ± 5 mm

ou de ± 2 %, la valeur la plus grande étant retenue.
4.4 Dispositif de mesure des angles, d’une exactitude de ± 0,5°.

4.5 Dispositif de mesure du couple, d’une exactitude de ± 5 % avec des paliers de réglage de 1 Nm

dans la plage de 0,5 Nm à 10 Nm.

4.6 Plan d’essai, de dimensions et de rigidité suffisantes pour supporter le cadre de marche pendant

les essais, tel que l’ensemble de la surface soit contenu entre deux plans parallèles imaginaires distants

de 5 mm. Le plan d’essai peut être réglable ou fixe.

NOTE 1 Un cadre en bois ou en acier avec une surface en contreplaqué peut être utilisé.

NOTE 2 Une surface d’essai de 1,5 m x 2 m est généralement suffisante.

4.7 Dispositifs d’arrêt, d’une hauteur suffisante pour empêcher le cadre de marche de bouger

pendant l’essai, sans interférer avec l’essai ou le cadre de marche.
4.8 Équipement de mesure de la pression de l’air, d’une exactitude de ± 5 %.
5 Conditions d’essai
Les conditions suivantes doivent être appliquées:
a) les essais doivent être effectués à une température ambiante de 21 °C ± 5 °C;
© ISO 2021 – Tous droits réservés 7
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ISO 11199-1:2021(F)

b) les parties réglables du cadre de marche doivent être réglées dans la position la plus défavorable

conformément aux instructions du fabricant, sauf indication contraire dans le mode opératoire

d’essai;

c) les roues pivotantes doivent être positionnées comme si le cadre de marche était avancé vers

l’avant, sauf spécification contraire dans le mode opératoire d’essai;

d) les poignées doivent être positionnées à leur distance et à leur angle maximaux pour obtenir la

condition la plus défavorable telle que spécifiée par le fabricant, sauf sp
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 11199-1
ISO/TC 173
Assistive products for walking
Secretariat: SIS
manipulated by both arms —
Voting begins on:
2021-02-01 Requirements and test methods —
Voting terminates on:
Part 1:
2021-03-29
Walking frames
Produits d’assistance à la marche manipulés avec les deux bras —
Exigences et méthodes d’essai —
Partie 1: Cadres de marche
ISO/CEN PARALLEL PROCESSING
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 11199-1:2021(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 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 11199-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 11199-1:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Apparatus ..................................................................................................................................................................................................................... 6

5 Test conditions ....................................................................................................................................................................................................... 6

6 General requirements and test methods .................................................................................................................................... 7

6.1 Risk analysis .............................................................................................................................................................................................. 7

6.2 Walking frames that can be dismantled ............................................................................................................................ 8

6.3 Fasteners ...................................................................................................................................................................................................... 8

6.4 User mass/Load limits ..................................................................................................................................................................... 8

6.5 Structure requirements ................................................................................................................................................................... 8

6.6 Brakes ............................................................................................................................................................................................................. 8

6.6.1 Requirements .................................................................................................................................................................... 8

6.6.2 Test method .......................................................................................................................................................................... 9

6.7 Handgrip ....................................................................................................................................................................................................... 9

6.8 Leg section and tip ............................................................................................................................................................................... 9

7 Materials ....................................................................................................................................................................................................................... 9

7.1 General ........................................................................................................................................................................................................... 9

7.2 Flammability ..........................................................................................................................................................................................10

7.3 Biocompatibility and toxicity ..................................................................................................................................................10

7.4 Infection and microbiological contamination ...........................................................................................................10

7.4.1 General...................................................................................................................................................................................10

7.4.2 Cleaning and disinfection ......................................................................................................................................10

7.5 Resistance to corrosion ................................................................................................................................................................10

8 Ingress of liquids ...............................................................................................................................................................................................10

9 Temperatures of parts that come in contact with human skin .........................................................................11

10 Safety of moving parts .................................................................................................................................................................................11

10.1 Squeezing ..................................................................................................................................................................................................11

10.2 Mechanical wear .................................................................................................................................................................................12

11 Prevention of traps for parts of the human body ............................................................................................................12

11.1 Holes and clearances ......................................................................................................................................................................12

11.2 V-shape openings ...............................................................................................................................................................................12

12 Folding, adjusting and locking mechanisms .........................................................................................................................12

12.1 General ........................................................................................................................................................................................................12

12.2 Folding mechanisms ........................................................................................................................................................................13

12.3 Locking mechanisms .......................................................................................................................................................................13

13 Lifting and carrying handles .................................................................................................................................................................13

13.1 General ........................................................................................................................................................................................................13

13.2 Requirement ..........................................................................................................................................................................................13

13.3 Test method ............................................................................................................................................................................................14

14 Surfaces, corners and edges ..................................................................................................................................................................14

15 Static stability .......................................................................................................................................................................................................14

15.1 Requirements for static stability ..........................................................................................................................................14

15.2 Test method for static stability ..............................................................................................................................................15

15.2.1 General requirement .................................................................................................................................................15

15.2.2 Forward-direction static stability test ........................................................................................................15

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ISO/FDIS 11199-1:2021(E)

15.2.3 Rearward-direction static stability test ....................................................................................................16

15.2.4 Sideway-direction static stability test ........................................................................................................16

16 Static strength ......................................................................................................................................................................................................17

16.1 Static strength of walking frame ...........................................................................................................................................17

16.1.1 General requirement .................................................................................................................................................17

16.1.2 Requirements for static strength of walking frame ........................................................................17

16.1.3 Test method for static strength of walking frame ............................................................................17

16.2 Static strength for the legs with tip ....................................................................................................................................18

16.2.1 General requirement .................................................................................................................................................18

16.2.2 Requirements for static strength of the legs with tip ....................................................................18

16.2.3 Test method for static strength of the legs with tip ........................................................................18

17 Durability test .......................................................................................................................................................................................................19

17.1 General requirement .......................................................................................................................................................................19

17.2 Requirement for durability .......................................................................................................................................................19

17.3 Test method for durability .........................................................................................................................................................19

18 Ergonomic principles ...................................................................................................................................................................................20

19 Packaging ..................................................................................................................................................................................................................20

20 Information supplied by the manufacturer ..........................................................................................................................20

20.1 General ........................................................................................................................................................................................................20

20.2 Information marked on the product .................................................................................................................................21

20.3 Instruction manual ...........................................................................................................................................................................21

20.4 Test report ................................................................................................................................................................................................22

Annex A (informative) Consideration items for hazards when designing the products ..............................24

Annex B (informative) General recommendations .............................................................................................................................26

Bibliography .............................................................................................................................................................................................................................28

iv © ISO 2021 – All rights reserved
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ISO/FDIS 11199-1:2021(E)
Foreword

ISO (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 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 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 types 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 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 information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 173, Assistive products, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive

products and accessibility, in accordance with the Agreement on technical cooperation between ISO and

CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 11199-1:1999), which has been technically

revised.
The main changes compared to the previous edition are as follows:
— 3.1 was changed to be in accordance with ISO 9999;

— Clause 6, on general requirements for assistive products for walking, was added.

A list of all parts in the ISO 11199 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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ISO/FDIS 11199-1:2021(E)
Introduction

A walking frame can be used when a person needs assistance when walking. The walking frame can

provide stability when walking and standing and reduce the risk of falling. Walking frames are designed

to support the user inside a frame to carry the user’s full body weight.
vi © ISO 2021 – All rights reserved
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 11199-1:2021(E)
Assistive products for walking manipulated by both
arms — Requirements and test methods —
Part 1:
Walking frames
1 Scope

This document specifies requirements and test methods for walking frames used as assistive products

for walking, manipulated by both arms, without accessories, unless specified in the particular test

procedure. This document also gives requirements relating to safety, ergonomics, performance and

information supplied by the manufacturer, including marking and labelling.

The requirements and tests are based on everyday use of walking frames as assistive products for

walking for a maximum user mass as specified by the manufacturer. This document includes walking

frames specified for a user mass of no less than 35 kg.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 8191-2, Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source:

match-flame equivalent

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 13732-1, Ergonomics of the thermal environment — Methods for the assessment of human responses to

contact with surfaces — Part 1: Hot surfaces
ISO 14971, Medical devices — Application of risk management to medical devices

ISO 15223-1, Medical device – Symbols to be used with medical device labels, labelling and information to

be supplied – Part 1: General requirements
ISO 20417, Medical devices — Information to be supplied by the manufacturer

ISO 24415-1, Tips for assistive products for walking — Requirements and test methods — Part 1:

Friction of tips
ISO 7000, Graphical symbols for use on equipment — Registered symbols

EN 614-1+A1, Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
© ISO 2021 – All rights reserved 1
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ISO/FDIS 11199-1:2021(E)
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
brake
device for slowing or stopping motion of a walking frame by contact friction
3.2
front handgrip reference point

position on the upper surface of the handgrip located 30 mm from the front end of the handgrip length

Note 1 to entry: See Figure 1.
3.3
handgrip

part of the walking frame that is intended by the manufacturer to be held by the hand when the walking

frame is in use
Note 1 to entry: See Figure 1.
Key
1 rear handgrip reference point 4 handgrip width
2 front handgrip reference point 5 front
3 handgrip length
Figure 1 — Details of a handgrip
2 © ISO 2021 – All rights reserved
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ISO/FDIS 11199-1:2021(E)
3.4
handgrip length
dimension of the handgrip measured where the hand rests
Note 1 to entry: See Figure 1.

Note 2 to entry: Where the front end or the rear end of the handgrip is not clear, the full length of the handgrip

that can comfortably support the mass of the user is defined as the handgrip length.

3.5
handgrip width

outside dimension of the handgrip measured at the thickest point where the hand rests

Note 1 to entry: See Figure 1.
3.6
handle
part of the walking frame to which the handgrip is attached
3.7
maximum user mass

greatest permissible mass of the person using the product, measured in kilograms (kg)

Note 1 to entry: The maximum user mass is specified by the manufacturer of the walking frame.

3.8
maximum width

maximum outside dimension of a walking frame when the adjustments are at their maximum. measured

horizontally at right angles to the direction of movement when the walking frame is in normal use

Note 1 to entry: See Figure 3.
3.9
parking brake

brake system that is intended for keeping the walking frame stationary on ground after being activated

3.10
pressure brake

running brake that engages when a vertical load is applied on the handgrips or on supporting points of

the walking frame
Note 1 to entry: See Figure 2
Key
1 wheel 4 rubber tip (brake)
2 spring 5 brake pad
3 frame
Figure 2 — Two types of pressure brake with technical details
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ISO/FDIS 11199-1:2021(E)
3.11
rear handgrip reference point

position on the upper surface of the handgrip located 30 mm from the rear end of the handgrip length

Note 1 to entry: See Figure 1.

Note 2 to entry: If the grip protrudes further than the handle, the measurement is made from the end of the handle.

3.12
reciprocal walking frame

walking frame where each side of the frame moves alternately, allowing unilateral forward progression

through the whole gait cycle
3.13
running brake

brake that is operated by the user during walking and where the braking effect depends proportionally

on the activation force applied
3.14
tip
part of a walking frame that is in contact with the ground
3.15
turning diameter

diameter of the largest circle described by a walking frame when the adjustments are at their maximum

and walking frame is turned through 360° about its own central vertical axis
Note 1 to entry: See Figure 3.
Key
1 width between handles 4 turning diameter
2 height 5 length
3 width
Figure 3 — Dimensions of a walking frame
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ISO/FDIS 11199-1:2021(E)
3.16
walking frame

frame that a person lifts to move, which enables to support full body weight and to maintain stability

and balance while walking or standing with hand grips, without forearm supports and with either four

tips or two tips and two castors/wheels
Note 1 to entry: See Figure 4.
Note 2 to entry: ISO 9999, Classification No. 12-06-03.

Note 3 to entry: Double or more castors/wheels used for one pivot position shall be counted as one castor/wheel.

The caster/wheel with a pressure brake shall be considered as the tip.

Note 4 to entry: Examples of walking frames include rigid or articulated walking frames assistive products for

walking with two wheels combination with two rubber stick buffers/tips.
Key
1 front 5 rear
2 front legs 6 rear legs
3 bracing members 7 head adjustment mechanism
4 handgrip 8 tips
Figure 4 — Example of walking frame
3.17
wheel width

maximum dimension of the tyre of the wheel measured within 5 mm up from the walking surface when

the walking frame is unloaded
Note 1 to entry: See Figure 5.
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ISO/FDIS 11199-1:2021(E)
Key
1 tyre 3 wheel width
2 0 to 5 mm up from the walking surface
Figure 5 — Wheel width measurement
4 Apparatus

4.1 Means to apply a force with an accuracy of ±5 % and with a rate of application less than 1 N/s.

4.2 Means to measure force with an accuracy of ±5 % in increments of 1 N.

4.3 Means to measure distance in the range of 0 m to 3 m with an accuracy of ±5 mm or ±2 %,

whichever is the greater
4.4 Means to measure angles to an accuracy of ±0,5°.

4.5 Means to measure torque with an accuracy of ±5 % in increments of 1 Nm in the range of 0,5 Nm

to 10 Nm

4.6 A test plane of sufficient size and stiffness to support the walking frame during testing, such that

the whole surface is contained between two imaginary parallel planes 5 mm a part. The test plane can be

adjustable, or fixed.
NOTE 1 A wooden or steel frame with a plywood surface can be used.
NOTE 2 A test surface of 1,5 m x 2 m is usually of sufficient size.

4.7 Stoppers devices of sufficient height to prevent the walking frame from moving during testing,

without interfering with the test or the walking frame.
4.8 Equipment for measuring pressure of air with an accuracy of ±5 %
5 Test conditions
The following conditions shall be applied:
a) The tests shall be performed at an ambient temperature of 21 °C ± 5 °C.

b) Adjustable parts of the walking frame shall be adjusted to the most adverse position according to

manufacturer’s instruction unless otherwise specified in the test procedure.
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ISO/FDIS 11199-1:2021(E)

c) The swivelling wheels shall be positioned as if the walking frame is run forward as far as a condition

is not specified in the test procedure.

d) The handles shall be positioned at their maximum distance and maximum angles to provide the

most adverse configuration as specified by the manufacturer as far as a condition is not specified

in the test procedure. When the longitudinal centreline of the handle and the direction of forward

motion are parallel, the angle is 0°. The angle shall always be recorded.

e) The running brake and parking brake shall not be operated as far as the test procedure does not

specify it.

f) All abnormalities such as breakage on each test shall be recorded and be distinguished from the

abnormalities on the subsequent tests.

g) During the stability tests, the walking frame shall be prevented from sliding or rolling before tilting

occurs. The results of the tests shall not be influenced by the means used. If the walking frame is

less stable with the height adjustment at a lower height, the least stable position shall be tested.

h) If the manufacturer offers alternative handle fittings as accessory equipment, all alternatives shall

be supplied with the walking frame when tested so that the walking frame can be tested in the

least favourable configuration (e.g. extended handles).

i) Before testing, the walking frame shall be inspected to check conformity with this document.

Any apparent defects shall be documented so that they shall not later be recorded as having been

caused by the tests.
j) A walking frame shall be tested in the following sequence:
— measurements;
— stability;
— brakes;
— handgrips;
— rubber tips;
— static strength of the walking frame;
— static strength of the legs;
— durability.
6 General requirements and test methods
6.1 Risk analysis

The safety of a walking frame shall be assessed by the manufacturer by identifying hazards and

estimating the risks ass
...

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