EN ISO 11334-4:2024

SLOVENSKI STANDARD
oSIST prEN ISO 11334-4:2023
01-maj-2023
Pripomočki za hojo, ki se upravljajo z eno roko - Zahteve in preskusne metode - 4.
del: Sprehajalne palice s tremi ali več nogami (ISO/DIS 11334-4:2023)
Assistive products for walking, manipulated by one arm - Requirements and test
methods - Part4: Walking sticks with three or more legs (ISO/DIS 11334-4:2023)
Technische Hilfen zum Gehen für einarmige Handhabung - Anforderungen und
Prüfverfahren - Teil 4: Gehstöcke mit drei oder mehr Beinen (ISO/DIS 11334-4:2023)
Produit d'assistance à la marche manipulés avec un bras - Exigences et méthodes
d'essai - Partie 4: Cannes à trois pieds ou plus (ISO/DIS 11334-4:2023)
Ta slovenski standard je istoveten z: prEN ISO 11334-4
ICS:
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
oSIST prEN ISO 11334-4:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 11334-4:2023
oSIST prEN ISO 11334-4:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11334-4
ISO/TC 173 Secretariat: SIS
Voting begins on: Voting terminates on:
2023-03-06 2023-05-29
Assistive products for walking, manipulated by one arm —
Requirements and test methods —
Part 4:
Walking sticks with three or more legs
ICS: 11.180.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11334-4:2023(E)
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 SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11334-4
ISO/TC 173 Secretariat: SIS
Voting begins on: Voting terminates on:

Assistive products for walking, manipulated by one arm —
Requirements and test methods —
Part 4:
Walking sticks with three or more legs
ICS: 11.180.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
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TECHNOLOGICAL, COMMERCIAL AND
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Reference number
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 11334-4:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Apparatus . 5
5 Test conditions .6
6 General requirements and test methods . 6
6.1 Risk analysis . 6
6.2 Maximum user mass/Load limits . 7
6.3 Structure requirements . 7
6.3.1 Handgrip . 7
6.3.2 Adjustment mechanisms and locking devices . 7
6.3.3 Leg section and tips . 7
6.3.4 Leg height from the ground of the walking stick for outside use . 7
6.3.5 Shaft distance from the user . 8
7 Materials . 8
7.1 General . 8
7.2 Biocompatibility and toxicity . 8
7.3 Infection and microbiological contamination . 8
7.3.1 General . 8
7.3.2 Cleaning and disinfection . 8
7.4 Resistance to corrosion . 8
8 Temperatures of parts that come in contact with human skin . 9
9 Prevention of traps for parts of the human body . 9
9.1 Holes and clearances . 9
9.2 V-shape openings . 9
10 Surfaces, corners and edges. 9
11 Static Stability .10
11.1 Requirements for static stability . 10
11.1.1 Inward direction static stability . 10
11.1.2 Outward direction, Forward direction and Backward direction static
stability . 10
11.2 Test methods for static stability . 10
11.2.1 Inward direction static stability test . 10
11.2.2 Outward direction, forward direction and backward direction static
stability test . 10
12 Static strength .12
12.1 Static strength of walking sticks .12
12.1.1 Requirements for static strength of walking sticks .12
12.1.2 Test methods for static strength of walking sticks .12
12.2 Static strength for the legs and separation part . 14
12.2.1 Requirements for static strength of the legs and separation part . . 14
12.2.2 Test methods for static strength of the legs and separation part . 14
13 Durability test .14
13.1 Requirements for durability . 14
13.2 Test methods for durability .15
14 Information supplied by the manufacturer .16
iii
oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
14.1 General . 16
14.2 Information marked on the product . 16
14.3 Instructions for use . 16
14.4 Test report . 17
Annex A (informative) Consideration items for hazards when designing the products .18
Annex B (informative) General recommendations .20
Bibliography .21
iv
oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(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 173, Assistive products, in collaboration with
European Committee for Standardization (CEN) Technical Committee CEN/TC923, 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 11334-4:1999), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— The minimum requirements for stability have been removed. The manufacturer shall however
declare the stability performance level for the specified direction.
— The static strength test for the legs and separation part was added.
— Clause 6 on general requirements for assistive products for walking was added.
A list of all parts in the ISO 11334 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.
v
oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
Introduction
A walking stick with three or more legs can be used when a person needs assistance for walking. The
walking stick with three or more legs can provide more stability when walking and standing compared
with other types of sticks and canes manipulated by one arm and can reduce the risk of falling.
vi
oSIST prEN ISO 11334-4:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 11334-4:2023(E)
Assistive products for walking, manipulated by one arm —
Requirements and test methods —
Part 4:
Walking sticks with three or more legs
1 Scope
This document specifies requirements and test methods of walking sticks with three or more legs being
used as assistive products for walking, manipulated by one arm, without accessories, unless specified
in the particular test procedure. This document also gives requirements related to safety, ergonomics,
performance and information supplied by the manufacturer, including marking and labelling.
The requirements and tests are based on every-day use of walking sticks with three or more legs
as assistive products for walking for a maximum user mass as specified by the manufacturer. This
document is for walking sticks with three or more legs specified for a user mass of no less than 35 kg.
This document is not applicable to walking sticks with three or more legs with underarm or forearm
support or with moving parts such as a universal joint.
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 9227, Corrosion tests in artificial atmospheres — Salt spray tests
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 14971, Medical devices — Application of risk management to medical devices
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
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
ISO 13732-1, Ergonomics of the thermal environment — Methods for the assessment of human responses to
contact with surfaces — Part 1: Hot surfaces
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
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
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
anatomic handgrip
A handgrip that is shaped in a way to match the shaped of the hand; anatomic handgrip exists in right-
hand and left-hand types
3.2
handgrip
part of the walking stick with is normally held in the hand when the walking stick is in use
3.3
handgrip length
dimension of the handgrip measured longitudinally 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 support the weight of the user is defined as the handgrip length.
Key
1 handgrip length
2 handgrip width
Figure 1 — Detail of handle and handgrip
3.4
handgrip loading pad
device capable of applying the test force to the handgrip.
Note 1 to entry: See Figure 2.
Note 2 to entry: For some anatomically shaped handgrips, it may be necessary to design a custom loading pad.
oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
Key
F force 2 handgrip loading pad
1 loading surface 3 tilt angle
Figure 2 — Handgrip loading pad
3.5
handgrip reference point
crossing point of vertical line through centre of shaft and handgrip
3.6
handgrip width
dimension of the handgrip measured length cross-sectionally to longitudinal direction where the hand
rests
Note 1 to entry: See Figure 1.
3.7
handle
that part of walking stick to which the handgrip is attached
Note 1 to entry: On most devices handgrip and handle can be part of the same piece
3.8
leg
frame or rod separated from the shaft which contact the ground
3.9
locking device
part of a walking stick which provides locking of the height and/or other adjustment mechanisms
3.10
separation part
part of a shaft to which separated leg attached
Note 1 to entry: See Figure 8, key 1.
oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
3.11
shaft
prop section of the walking stick. In most types of walking sticks shaft is made by two telescopic tubes
used for the height adjustment
3.12
tip
part of a walking stick which is contact with the ground
Note 1 to entry: see Figure 4, key 10.
3.13
maximum user mass
body mass of the person using the walking stick as an assistive product for walking
3.14
walking-stick depth
maximum outside dimension of a walking stick measured horizontally in the direction of movement
Note 1 to entry: See Figure 3.
Key
1 handgrip length 3 walking-stick depth
2 walking-stick width 4 walking-stick height
Figure 3 — Measurements of a walking sticks with three or more legs
3.15
walking-stick height
vertical distance from the highest point on the handgrip to the ground where the tips of walking stick
rest
Note 1 to entry: See Figure 3.
3.16
height adjustment device
device for adjusting the height of the walking stick, e.g. button type or plug-in clips etc.
oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
3.17
walking-stick width
maximum outside dimension of a walking stick measured horizontally at right angles to the direction
of movement
Note 1 to entry: See Figure 3.
3.18
walking sticks with three or more legs
walking sticks with three or more legs and a handle without an underarm or forearm support or moving
parts such as a universal joint
Note 1 to entry: ISO 9999 2022, Classification No. 12 03 16
Note 2 to entry: Throughout this document the term walking stick refers to a walking stick with three or more
legs.
Key
1 forward direction 9 base
2 handgrip 10 tip
3 rearward direction 11 inside front leg
4 shaft (upper) 12 inside rear leg
5 height adjustment device 13 outside front leg
6 height adjustment hole 14 outside rear leg
7 locking device 15 outside leg
8 shaft (lower)
Figure 4 — Identification of parts of walking sticks with three or more legs
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 grade of the test plane to an accuracy of ±5°
oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
4.5 A test plane of sufficient size and stiffness to support the walking stick during testing, such that
the whole surface is contained between two imaginary parallel planes 5 mm a part.
The test plane shall have an approximately 8 mm high stopper and shall be able to be tilted from the
horizontal with the centreline of the hinges paralleled to the line joining the axis of the two legs being
tested.
NOTE A wooden or steel frame with a plywood surface can be used.
4.6 Stoppers devices of sufficient height to prevent the walking stick from moving during testing,
without interfering with the test or the walking stick.
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 stick shall be adjusted to the most adverse position according to
manufacturer’s instruction unless otherwise specified in the test procedure. The most adverse
condition includes that the height of the handgrip shall be set at maximum.
c) All abnormalities such as breakage or permanent deformation on each test shall be recorded and
be distinguished from the abnormalities on the subsequent tests.
d) During the stability tests, the walking stick shall be prevented from sliding before tilting occurs.
The results of the tests shall not be influenced by the means used.
e) If the manufacturer offers alternative handle fittings as accessory equipment, all alternatives shall
be supplied with the walking stick when tested so that the walking stick can be tested in the least
favourable configuration (e.g. extended handles).
f) Before testing, the walking stick shall be inspected. Any apparent defects shall be documented so
that they shall not later be recorded as having been caused by the tests.
g) One walking stick shall be tested in the following sequence:
— measurements;
— stability;
— static strength of the walking stick;
— static strength of the legs and separation part;
— durability;
— adjustment mechanism and locking devices.
The static strength test of the legs and separation part shall be done with the leg without tip. The
spare tip shall be installed with the leg for the durability test.
6 General requirements and test methods
6.1 Risk analysis
The safety of a walking stick 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.
oSIST prEN ISO 11334-4:2023
ISO/DIS 11334-4:2023(E)
When a walking stick is intended by the manufacturer to be used in combination with other
...