EN ISO 11199-2:2021

SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN ISO 11199-2:2005
Pripomočki za hojo, ki se upravljajo z obema rokama - Zahteve in preskusne
metode - 2. del: Rolatorji (ISO 11199-2:2021)
Assistive products for walking manipulated by both arms - Requirements and test
methods - Part 2: Rollators (ISO 11199-2:2021)
Technische Hilfen zum Gehen für beidarmige Handhabung - Anforderungen und
Prüfverfahren - Teil 2: Rollatoren (ISO 11199-2:2021)
Produits d’assistance à la marche manipulés avec les deux bras - Exigences et
méthodes d’essai - Partie 2: Déambulateurs (ISO 11199-2:2021)
Ta slovenski standard je istoveten z: EN ISO 11199-2:2021
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 11199-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 11.180.10 Supersedes EN ISO 11199-2:2005
English Version
Assistive products for walking manipulated by both arms -
Requirements and test methods - Part 2: Rollators (ISO
11199-2:2021)
Produits d'assistance à la marche manipulés avec les Technische Hilfen zum Gehen für beidarmige
deux bras - Exigences et méthodes d'essai - Partie 2: Handhabung - Anforderungen und Prüfverfahren - Teil
Déambulateurs (ISO 11199-2:2021) 2: Rollatoren (ISO 11199-2:2021)
This European Standard was approved by CEN on 12 June 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 11199-2:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11199-2:2021) 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 January 2022, and conflicting national standards shall
be withdrawn at the latest by January 2022.
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 11199-2:2005.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
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 11199-2:2021 has been approved by CEN as EN ISO 11199-2:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 11199-2
Third edition
2021-07
Assistive products for walking
manipulated by both arms —
Requirements and test methods —
Part 2:
Rollators
Produits d’assistance à la marche manipulés avec les deux bras —
Exigences et méthodes d’essai —
Partie 2: Déambulateurs
Reference number
ISO 11199-2:2021(E)
©
ISO 2021
ISO 11199-2:2021(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 11199-2:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Apparatus . 7
5 Test conditions . 8
6 General requirements and test methods . 9
6.1 Risk analysis . 9
6.2 Rollators that can be dismantled . . 9
6.3 Fasteners . 9
6.4 User mass/load limit . 9
6.5 Structure requirements . 9
6.6 Brakes .10
6.6.1 General requirements .10
6.6.2 Brake effectiveness .10
6.6.3 Durability of brakes .11
6.7 Handgrip .11
7 Materials .11
7.1 General .11
7.2 Flammability .12
7.2.1 General.12
7.2.2 Upholstered parts .12
7.3 Biocompatibility and toxicity .12
7.4 Infection and microbiological contamination .12
7.4.1 General.12
7.4.2 Cleaning and disinfection .12
7.5 Resistance to corrosion .12
8 Ingress of liquids .13
9 Temperatures of parts that come in contact with human skin .13
10 Safety of moving parts .13
10.1 Squeezing .13
10.2 Mechanical wear .14
11 Prevention of traps for parts of the human body .14
11.1 Holes and clearances .14
11.2 V-shape openings .15
12 Folding, adjusting and locking mechanisms .15
12.1 General .15
12.2 Folding mechanisms .15
12.3 Locking mechanisms .15
13 Carrying handles .15
13.1 General .15
13.2 Requirements .16
13.3 Test method .16
14 Surfaces, corners and edges .16
15 Static stability .17
15.1 Requirements for static stability .17
15.2 Test method for static stability .17
ISO 11199-2:2021(E)
15.2.1 Forward-direction static stability test .17
15.2.2 Rearward-direction static stability test .18
15.2.3 Sideway-direction static stability test .19
15.2.4 Accessory equipment static stability test .20
16 Static strength .20
16.1 Static strength of resting seat .20
16.1.1 General.20
16.1.2 Requirements for static strength of resting seat .20
16.1.3 Test method for static strength of resting seat .20
16.2 Static strength of the rollator .21
16.2.1 General.21
16.2.2 Requirements for static strength of the rollator.21
16.2.3 Test method for static strength of the rollator .21
16.3 Strength of backrest .22
16.3.1 General.22
16.3.2 Requirement for strength of backrest .22
16.3.3 Test method for strength of backrest .22
17 Durability test .22
17.1 Requirement for durability .23
17.2 Test method for durability .23
18 Ergonomic principles .24
19 Packaging .24
20 Information supplied by the manufacturer .25
20.1 General .25
20.2 Information marked on the product .25
20.3 Instruction manual .25
20.4 Test report .26
Annex A (informative) Consideration items for hazards when designing the products .28
Annex B (informative) General recommendations .30
Bibliography .32
iv © ISO 2021 – All rights reserved

ISO 11199-2:2021(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 third edition cancels and replaces the second edition (ISO 11199-2:2005), 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;
— subclause 16.3 on strength of backrest was added;
— Clause 6 on general requirements for assistive products 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 11199-2:2021(E)
Introduction
A rollator can be used when a person needs assistance when walking. The rollator can provide stability
when walking and standing and reduce the risk of falling. Rollators are designed to support the user
inside a frame to carry the user’s weight. Rollators can be equipped with a resting seat, backrest and/
or shopping bag. Rollators are not intended to be moved with the user on the seat like a wheelchair. The
seat is provided as a resting seat with brakes engaged.
vi © ISO 2021 – All rights reserved

INTERNATIONAL STANDARD ISO 11199-2:2021(E)
Assistive products for walking manipulated by both
arms — Requirements and test methods —
Part 2:
Rollators
1 Scope
This document specifies requirements and test methods of rollators being used as assistive products for
walking with wheels, 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 every-day use of rollators as assistive products for walking
for a maximum user mass as specified by the manufacturer. This document includes rollators specified
for a user mass of no less than 35 kg.
This document is not applicable to rollators with horizontal forearm supports, classified as walking
tables, for which ISO 11199-3 is applicable.
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 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 11199-2:2021(E)
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
brake
device for slowing or stopping motion of a rollator by contact friction
3.2
front handgrip reference point
position on the upper surface of the handgrip (3.3) located 30 mm from the front end of the handgrip
length
Note 1 to entry: See Figure 1.
3.3
handgrip
part of the rollator that is intended by the manufacturer to be held by the hand when the rollator is in
use
Note 1 to entry: See Figure 1.
2 © ISO 2021 – All rights reserved

ISO 11199-2:2021(E)
Dimensions in millimetres
Key
b
1 rear handgrip reference point Handgrip length.
c
2 front handgrip reference point Handgrip width.
a
Front.
Figure 1 — Detailed drawing of a handgrip
3.4
handgrip length
dimension of the handgrip (3.3) 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 (3.3) measured at the thickest point where the hand rests
Note 1 to entry: See Figure 1.
ISO 11199-2:2021(E)
3.6
handle
part of the rollator to which the handgrip (3.3) 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 rollator.
3.8
maximum width
maximum outside dimension of a rollator when the width is adjusted at its maximum, measured
horizontally at right angles to the direction of movement
Note 1 to entry: See Figure 4.
3.9
parking brake
braking system that is intended for keeping the rollator stationary on ground after being activated
3.10
rear handgrip reference point
position on the upper surface of the handgrip (3.3) located 30 mm from the rear end of the handgrip
length
Note 1 to entry: See Figure 1.
3.11
resting seat
seat for the user to take a rest
3.12
rollator
walking device, which can be moved by pushing or pulling, that enables a person to maintain stability
and balance while walking, that has handgrips (3.3) or a transverse bar and three or more castors/
wheels without forearm supports
Note 1 to entry: See Figure 2.
Note 2 to entry: Double or more castors/wheels used for one pivot position shall be counted as one castor/wheel.
Note 3 to entry: Included are, for example, rollators with a seat for resting, knee walkers, reverse rollators that
are pulled with the opening in the front.
Note 4 to entry: ISO 9999, Classification No. 12 06 06.
4 © ISO 2021 – All rights reserved

ISO 11199-2:2021(E)
Key
1 brake handle 6 bracing member
2 height adjustment mechanism 7 wheels
a
3 folding mechanism Rear.
b
4 handle/handgrip Front.
5 resting seat
Figure 2 — Example of a rollator
3.13
rollator height
vertical distance from the highest point of the handle (3.6) to the ground surface
Note 1 to entry: See Figure 4.
3.14
running brake
braking system that is operated by the user during walking to reduce the speed of the rollator or stop
it completely
Note 1 to entry: See Figure 3.
ISO 11199-2:2021(E)
Key
a
1 rear handgrip reference point Front.
b
2 front handgrip reference point Brake grip distance.
Figure 3 — Brake grip distance
3.15
shopping bag
bag attached on the rollator to carry goods
3.16
turning width
minimum distance between two parallel limiting walls in between which a rollator can be turned 180°
Note 1 to entry: See Figure 4.
Note 2 to entry: The adjustments are to be at their maximum.
Key
a d
Turning width. Width.
b e
Width between handles. Height.
c
Length.
Figure 4 — Dimensions of a rollator
6 © ISO 2021 – All rights reserved

ISO 11199-2:2021(E)
3.17
wheel width
maximum dimension of the tyre of the wheel measured within 5 mm up from the walking surface when
the rollator is unloaded
Note 1 to entry: See Figure 5.
Key
b
1 tyre Wheel width.
a
0 mm 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 rollator 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 rollator from moving during testing, without
interfering with the test or the rollator.
4.8 Equipment for measuring pressure of air with an accuracy of ±5 %.
4.9 Seat loading pad shall be of a rectangular construction 340 mm ± 3 mm width, minimum 200 mm
long and the height to be sufficient for the loading pad to be stiff enough to take the test load without
ISO 11199-2:2021(E)
deforming significantly. The base of the seat loading pad that contacts the seat shall be covered with
3 3
cellular foam of density 75 kg/m ± 15 kg/m . The lining shall be 15 mm ± 3 mm thick and be chamfered
at approximately 45° at a depth of approximately 10 mm to 15 mm along the side edges.
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 rollator shall be adjusted to the most adverse position according to
manufacturer’s instructions unless otherwise specified in the test procedure.
c) The Swivelling wheels shall be positioned as if the rollator 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 rollator 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 rollator 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 rollator when tested so that the rollator can be tested in the least favourable
configuration (e.g. extended handles).
i) Before testing, the rollator 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) One rollator shall be tested in the following sequence:
— measurements;
— stability;
— brakes;
— handgrips;
— strength of resting seat;
— strength of the backrest;
— static strength of the rollator;
— durability.
8 © ISO 2021 – All rights reserved

ISO 11199-2:2021(E)
6 General requirements and test methods
6.1 Risk analysis
The safety of a rollator 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 rollator 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.
6.2 Rollators that can be dismantled
If it is intended that a rollator 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 reassembling the rollator according to the manufacturer's 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 limit
The maximum user mass shall be specified by the manufacturer. For load carrying accessories, the load
capacity of the accessories shall be specified by the manufacturer.
6.5 Structure requirements
A rollator 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 front wheel diameter shall be greater or equal to 75 mm;
— the rollator shall be equipped with parking brakes operating on two wheels.
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;
— the rollator shall be equipped with brakes operating on two wheels. The user shall be able to
manipulate the brakes when walking;
— a rollator shall be equipped with parking brakes operating on two wheels.
ISO 11199-2:2021(E)
6.6 Brakes
6.6.1 General requirements
All rollators shall have running brakes that are easy to operate by the user when the rollator is in
motion.
All rollators that have a resting seat shall have parking brakes that can be integrated with the running
brakes.
All rollators that are designed for outdoor use shall have parking brakes that can be integrated with the
running brakes.
Maximum grip distance for operating running brakes shall be not greater than 75 mm, measured (see
Figure 3, Key 1).
NOTE For rollators with pressure brakes, there is no grip distance.
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 rollator, tools shall not
be required (e.g. height adjustment).
6.6.2 Brake effectiveness
6.6.2.1 Requirements
This requirement applies to both, parking brakes and running brakes.
The rollator shall not move more than 10 mm in 1 min if the running brake or the parking brake is
activated.
The maximum force to apply and release the brakes shall not exceed
— 60 N for pushing forces, and
— 40 N for pulling forces.
Operating device acts on both wheels (central brakes), each of the brake-operating devices shall be
tested separately.
6.6.2.2 Test method
Place the rollator with its wheels on the test plane specified in 4.6. Position the rollator so that a line
through the axles of the wheels is parallel ±3° to the axis of tip of the test plane. Apply the loading force
vertically to the rollator 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 rollator 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 test plane to an angle of 6° +0,5/-0,0. Remove the stoppers. The friction
between the braking wheels and the top surface of the plane shall be such that the wheels do not slide.
Leave the rollator for 1 min. If the wheels turn, the rollator shall not move more than 10 mm in 1 min.
Repeat the procedure with the rollator facing uphill as in Figure 8.
10 © ISO 2021 – All rights reserved

ISO 11199-2:2021(E)
Measure the forces necessary to set and to release the brakes, to an accuracy of ±2 %, by applying the
force along the grip distance line of each brake-operating devices.
If the brake-operating device is a lever that is not operated by squeezing a bar against the handgrip
with fingers, the force shall be applied at a point 20 mm inwards from the end of the lever and in a
direction perpendicular to the line connecting the point of force application with the pivot of the lever.
6.6.3 Durability of brakes
6.6.3.1 Requirements
The following requirement applies to both parking brakes and running brakes:
No part of the brakes shall crack or break and the effectiveness of the brake shall meet the requirements
in 6.6.2.1 after the durability test.
6.6.3.2 Test methods
If the rollator has two identical running or parking brakes, only one of the running and parking brakes
shall be tested.
The maximum force to apply and release the brakes for the test shall not exceed
— 60 N for pushing forces, and
— 40 N for pulling forces.
Place the rollator with its wheels on the test plane specified in 4.6. Move the lever of the brake from
non-braking position to the braking position for 100 000 cycles at a frequency not greater than 0,5 Hz.
The maintenance can be carried out during the testing only in accordance with the manufacture’s
instructions. The durability test of the parking brake and running brake can be performed sequentially
or simultaneously.
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 rollator.
7 Materials
7.1 General
The materials used in a rollator should not mark, or scratch.
The rollator materials should not cause discoloration of skin or clothing when the rollator 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 11199-2:2021(E)
7.2 Flammability
7.2.1 General
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.
7.2.2 Upholstered parts
If the manufacturer claims that the upholstered parts are resistant to ignition by cigarette, progressive
smouldering ignition and flaming ignition shall not occur when the materials used for the upholstered
parts of an assistive product are tested in accordance with ISO 8191-2.
7.3 Biocompatibility and toxicity
Materials that come into contact with the human body shall be assessed for biocompatibility using the
guidance in 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 that 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 rollator and its auxiliary parts should be designed to be accessible for cleaning to prevent cr
...