EN ISO 11199-1:2021

SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN ISO 11199-1:2000
Pripomočki za hojo, ki se upravljajo z obema rokama - Zahteve in preskusne
metode - 1. del: Hodulje (ISO 11199-1:2021)
Assistive products for walking manipulated by both arms - Requirements and test
methods - Part 1: Walking frames (ISO 11199-1:2021)
Hilfsmittel zum Gehen für beidarmige Handhabung - Anforderungen und Prüfverfahren -
Teil 1: Gehrahmen (Gehböcke) (ISO 11199-1:2021)
Produits d’assistance à la marche manipulés avec les deux bras - Exigences et
méthodes d’essai - Partie 1: Cadres de marche (ISO 11199-1:2021)
Ta slovenski standard je istoveten z: EN ISO 11199-1:2021
ICS:
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11199-1
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2021
EUROPÄISCHE NORM
ICS 11.180.10 Supersedes EN ISO 11199-1:1999
English Version
Assistive products for walking manipulated by both arms -
Requirements and test methods - Part 1: Walking frames
(ISO 11199-1:2021)
Produits d'assistance à la marche manipulés avec les Hilfsmittel zum Gehen für beidarmige Handhabung -
deux bras - Exigences et méthodes d'essai - Partie 1: Anforderungen und Prüfverfahren - Teil 1: Gehrahmen
Cadres de marche (ISO 11199-1:2021) (Gehböcke) (ISO 11199-1:2021)
This European Standard was approved by CEN on 30 April 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11199-1:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11199-1:2021) has been prepared by Technical Committee ISO/TC 173
"Assistive products" in collaboration with Technical Committee CEN/TC 293 “Assistive products and
accessibility” the secretariat of which is held by SIS.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2021, and conflicting national standards
shall be withdrawn at the latest by December 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11199-1:1999.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11199-1:2021 has been approved by CEN as EN ISO 11199-1:2021 without any
modification.
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
ISO 11199-1:2021(E)
© 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

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
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

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 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

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 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

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
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

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.
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

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 11199-1:2021(E)
6.2 Walking frames that can be dismantled
If it is intended that a walking frame can be dismantled for storage or transportation, it shall not be
possible to reassemble it in a manner that presents a hazard. Hazard condition should be checked by
disassembling and re-assembling the walking frame according to the manufacturer instructions.
The fasteners that are loosened or removed to allow dismantling shall not be single use fasteners.
NOTE Single use fasteners include but are not limited to self-locking nuts/screws, wood screws and self-
tapping screws. Bolts are examples of fasteners that can be used more than once.
6.3 Fasteners
All load-bearing fasteners shall be either self-locking or fitted with a locking device to prevent
inadvertent detachment.
6.4 User mass/Load limits
The maximum user mass shall be declared by the manufacturer. For load carrying accessories, the load
capacity of the accessories shall be declared by the manufacturer.
6.5 Structure requirements
A walking frame shall be designed to be manoeuvrable for indoor or outdoor use or a combination of
the two:
For indoor use on a level surface
— the width of reciprocating walking frames, when reciprocated, shall be not less than 90 % of
maximum width,
— the front wheel diameter shall be greater or equal to 75 mm, and
— the walking frame shall be equipped with parking brakes operating on two wheels. Rubber tips are
deemed to be such parking brakes.
For outdoor use
— the front wheel diameter shall be greater or equal to 180 mm,
— the wheel width shall be greater or equal to 22 mm, and
— the walking frame shall be equipped with brakes operating on two wheels. The user shall be able to
manipulate the brakes when walking. Rubber tips are deemed to be such brakes.
6.6 Brakes
6.6.1 Requirements
When tested in accordance with the test method in 6.6.2, the walking frame shall not move more than
10 mm in 1 min.
If the effectiveness of the brake will be reduced by wear, it shall have means for the compensation of
wear.
Brake performance shall not be adversely affected by folding, unfolding or adjusting actions. If
readjustment of the brakes is necessary following an adjustment action of the walking frame, tools
shall not be required (e.g. height adjustment).
8 © ISO 2021 – All rights reserved

ISO 11199-1:2021(E)
6.6.2 Test method
All brakes shall be tested simultaneously. If either brake-operating device acts on both wheels (central
brakes), each of the brake-operating device shall be tested separately.
The walking frame shall be placed with its tips and wheels on a test plane specified in 4.6. Position the
walking frame so that a line through the axles of the wheel/tip is parallel ±3° to the axis of tip of the
test plane. Apply the loading force vertically to the walking frame at the midpoint of the line joining the
front handgrip reference points on the two handgrips.
For a user mass of 100 kg, the loading force shall be 500 N ± 10 N. If the maximum user mass specified
for the walking frame deviates from a user mass of 100 kg, the loading force shall be 5,0 N per kilogram
of the maximum user mass ±2 %. The load shall be no less than 175 N ± 3,5 N.
Activate the brakes by applying the force specified in Table 3 to each of the brake-operating devices
along the grip distance. Tilt the plane to an angle of 6° to test the forward direction braking performance
(Figure 7). The friction between the braking wheels and the top surface of the plane shall be such that
the wheels do not slide. Remove the stops. Leave the walking frame for 1 min. If the wheels turn, record
the time for the walking frame to move 10 mm.
6.7 Handgrip
The handgrip width shall be no less than 20 mm and not more than 50 mm. This shall be checked by
measurement.
NOTE This requirement is not applicable to anatomic handgrips.
The handgrip shall be securely fixed to the handle of the walking frame.
6.8 Leg section and tip
Where there is no wheel, the leg section shall end in a tip designed to prevent the leg section from
piercing through it, when the walking frame is used as intended by the manufacturer.
Where there is no wheel, the tip shall be replaceable.
Where there is no wheel, the tip shall not cause discolouring of the walking surface.
The part of the tip that contacts the walking surface shall have a minimum diameter of 35 mm.
The rubber tip shall be securely fixed to the leg of the walking frame.
The rubber tip shall fulfil the requirements of ISO 24415-1.
7 Materials
7.1 General
The materials used in a walking frame should not mark, or scratch.
The walking frame materials should not cause discoloration of skin or clothing when the walking frame
is in normal use.
Manufacturers should, wherever possible, use materials that can be recycled for further use. It shall be
stated in the instructions for use which parts can be recycled.
ISO 11199-1:2021(E)
7.2 Flammability
Risk of flammability that can affect user safety shall be assessed by the manufacturer in the risk
analysis. Parts identified by risk of flammability shall be tested according ISO 8191-2. Residual risks
should be reported in the instruction.
7.3 Biocompatibility and toxicity
Materials that come into contact with the human body shall be assessed for biocompatibility in
accordance with ISO 10993-1.
The assessment shall also take into account the intended use and contact by those involved in user care.
The assistive products shall be designed and manufactured in such a way as to reduce to a minimum
the risks posed by substances leaking from the assistive product. Special attention shall be given to
substances which are carcinogenic, mutagenic or toxic to reproduction and other substances of very
high concern (SVHCs).
The result of the assessment shall be incorporated in the risk analysis (see 6.1).
7.4 Infection and microbiological contamination
7.4.1 General
The walking frame and its auxiliary parts should be designed to be accessible for cleaning to prevent
cross infection.
7.4.2 Cleaning and disinfection
The method and suitable cleaning and/or disinfection materials shall be described in the information
supplied by the manufacturer.
NOTE For guidance see B.1.
If a walking frame is intended to be cleaned by automatic washing systems or hand-held jet stream/
steam washing, the details of the procedure, such as temperature, pressure, flow and pH value of the
cleaning/rinsing solution shall be described in the instructions for use. Where practicable, the walking
frame shall be labelled with appropriate symbols to represent the method of cleaning. See examples of
labelling and an example of testing of machine washable walking frame in B.2.
7.5 Resistance to corrosion
The risk of corrosion affecting the safety of the user or an assistant shall be assessed in the risk analysis
(see 6.1). Assistive products for walking that are identified to be at risk of corrosion shall be sufficiently
protected against corrosion.
The salt spray test in accordance with ISO 9227 with a test duration of 72 hours can be used.
8 Ingress of liquids
If liquid can come unintentionally into any cavities or enclosure, it shall be able to drain through drain
holes again.
The hazards that can be caused by the ingress of liquids shall be assessed in the risk analysis (see 6.1).
NOTE Hazards can be risk of corrosion or bacterial growth.
Test if there is a way for the liquid to get out of the enclosure or any cavities by using procedures as in
normal use and handling of the product. If possible, tilt the product in different directions to verify this.
10 © ISO 2021 – All rights reserved

ISO 11199-1:2021(E)
9 Temperatures of parts that come in contact with human skin
The risk analysis (see 6.1) shall identify hazards and evaluate the risks associated with the surface
temperature of parts that can come into contact with human skin during the intended conditions of use.
The risk analysis shall use the following:
a) the range of ambient temperatures to be expected during the intended use and foreseeable misuse;
NOTE These temperatures could include direct exposure to sunshine, extreme cold, saunas, etc.
b) the ergonomic data on acceptable temperatures of touchable surfaces in accordance with
ISO 13732-1;
c) the use of the walking frame by people with insensitive skin (i.e. cannot feel heat) and/or damaged
skin: in this case the maximum temperature shall not exceed 41° C when measured in accordance
with the test methods given in ISO 13732-1; except that
1) if a manufacturer cannot meet this requirement without impairing the intended performance
of the walking frame, each product should be supplied with a warning identifying which
surfaces may reach a higher temperature than that specified and description of the precautions
necessary to offset the increased risk; and
2) if a manufacturer cannot meet the surface temperature requirement, the reasons shall be set
out in the technical documentation.
10 Safety of moving parts
10.1 Squeezing
If the intended purpose cannot be achieved without a hazard such as risk of squeezing (e.g. the elbow or
knee flexion of limb prothesis)
a) any moving parts that constitute a safety hazard shall be provided with guards that can only be
removed by the use of a tool, or
b) the gap between exposed parts of a walking
...