SIST EN ISO 11199-2:2021
(Main)Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2021)
Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2021)
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.
Technische Hilfen zum Gehen für beidarmige Handhabung - Anforderungen und Prüfverfahren - Teil 2: Rollatoren (ISO 11199-2:2021)
Dieser Teil von ISO 11199 legt Anforderungen und Prüfverfahren für Rollatoren, die als Gehhilfen mit Rädern genutzt und mit beiden Armen gehandhabt werden, ohne Zubehör fest, sofern es in dem bestimmten Prüfverfahren nicht anders festgelegt ist. Dieser Teil von ISO 11199 enthält außerdem Anforderungen bezüglich der Sicherheit, Ergonomie und Leistungsfähigkeit und der vom Hersteller bereitzustellenden Informationen, einschließlich Kennzeichnung und Aufschriften.
Die Anforderungen und Prüfungen beruhen auf dem alltäglichen Gebrauch von Rollatoren als Gehhilfen für Personen mit einem vom Hersteller festgelegtem Höchstgewicht. Dieser Teil von ISO 11199 schließt Rollatoren ein, die für Personen mit einem Körpergewicht von mindestens 35 kg bestimmt sind.
Dieser Teil von ISO 11199 gilt nicht für Rollatoren mit waagerechten Unterarmstützen, die als Gehwagen eingeteilt sind und für die ISO 11199-3 gilt.
Produits d’assistance à la marche manipulés avec les deux bras - Exigences et méthodes d’essai - Partie 2: Déambulateurs (ISO 11199-2:2021)
Le présent document spécifie les exigences et les méthodes d’essai applicables aux déambulateurs utilisés comme des produits d’assistance à la marche équipés de roues, manipulés avec les deux bras, et dépourvus d’accessoires, sauf indication contraire dans le mode opératoire d’essai concerné. Le présent document donne également les exigences en matière de sécurité, d’ergonomie, de performances et d’informations fournies par le fabricant (marquage et étiquetage compris).
Les exigences et les essais reposent sur une utilisation quotidienne des déambulateurs comme produits d’assistance à la marche pour le poids maximal de l’utilisateur spécifié par le fabricant. Le présent document comprend les déambulateurs spécifiés pour les utilisateurs ayant un poids d’au moins 35 kg.
Le présent document ne s’applique pas aux déambulateurs dotés de supports d’avant-bras horizontaux, classés comme tables de marche, auxquelles s’applique l’ISO 11199-3.
Pripomočki za hojo, ki se upravljajo z obema rokama - Zahteve in preskusne metode - 2. del: Rolatorji (ISO 11199-2:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11199-2:2021
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
SIST EN ISO 11199-2:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11199-2:2021
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SIST EN ISO 11199-2:2021
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.
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SIST EN ISO 11199-2:2021
EN ISO 11199-2:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11199-2:2021
EN ISO 11199-2:2021 (E)
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.
3
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SIST EN ISO 11199-2:2021
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SIST EN ISO 11199-2:2021
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
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SIST EN ISO 11199-2:2021
ISO 11199-2:2021(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
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SIST EN ISO 11199-2:2021
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 2021 – All rights reserved iii
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SIST EN ISO 11199-2:2021
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
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SIST EN ISO 11199-2:2021
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 2021 – All rights reserved v
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SIST EN ISO 11199-2:2021
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
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SIST EN ISO 11199-2:2021
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 2021 – All rights reserved 1
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SIST EN ISO 11199-2:2021
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
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SIST EN ISO 11199-2:2021
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 2021 – All rights reserved 3
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SIST EN ISO 11199-2:2021
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 hand
...
SLOVENSKI STANDARD
oSIST prEN ISO 11199-2:2020
01-september-2020
Pripomočki za hojo, ki se upravljajo z obema rokama - Zahteve in preskusne
metode - 2. del: Rolatorji (ISO/DIS 11199-2:2020)
Assistive products for walking, manipulated by both arms - Requirements and test
methods - Part 2: Rollators (ISO/DIS 11199-2:2020)
Mit beiden Armen gehandhabte Gehhilfen - Anforderungen und Prüfverfahren - Teil 2:
Rollatoren (ISO/DIS 11199-2:2020)
Aides à la marche manipulées avec les deux bras - Exigences et méthodes d'essai -
Partie 2: Déambulateurs (ISO/DIS 11199-2:2020)
Ta slovenski standard je istoveten z: prEN ISO 11199-2
ICS:
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
oSIST prEN ISO 11199-2:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11199-2:2020
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oSIST prEN ISO 11199-2:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11199-2
ISO/TC 173 Secretariat: SIS
Voting begins on: Voting terminates on:
2020-06-11 2020-09-03
Assistive products for walking, manipulated by both
arms — Requirements and test methods —
Part 2:
Rollators
Aides à la marche manipulées avec les deux bras — Exigences et méthodes d'essai —
Partie 2: Déambulateurs
ICS: 11.180.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
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 11199-2:2020(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 2020
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(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 . 7
6 General requirements and test methods . 8
6.1 Risk analysis . 8
6.2 Rollators that can be dismantled . . 8
6.3 Fasteners . 8
6.4 User mass/Load limits . 8
6.5 Structure requirements . 8
6.6 Brakes . 9
6.6.1 General requirements . 9
6.6.2 Brake test . . 9
6.7 Handgrip .10
7 Materials .10
7.1 General .10
7.2 Flammability .10
7.2.1 Upholstered parts .10
7.3 Biocompatibility and toxicity .10
7.4 Infection and microbiological contamination .11
7.4.1 General.11
7.4.2 Cleaning and disinfection .11
7.5 Resistance to corrosion .11
8 Ingress of liquids .11
9 Temperatures of parts that come in contact with human skin .11
10 Safety of moving parts .12
10.1 Squeezing .12
10.2 Mechanical wear .12
11 Prevention of traps for parts of the human body .13
11.1 Holes and clearances .13
12 Folding, adjusting and locking mechanisms .13
12.1 General .13
12.2 Folding mechanisms .14
12.3 Locking mechanisms .14
13 Carrying handles .14
13.1 General .14
13.2 Requirement .14
13.3 Test method .14
14 Surfaces, corners and edges .15
15 Stability .15
15.1 Requirements for static stability .15
15.2 Test method for static stability .15
15.2.1 Forward-direction stability test .15
15.2.2 Rearward-direction stability test .16
15.2.3 Sideway-direction stability test .17
© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(E)
15.2.4 Accessory equipment stability test .18
16 Static strength .18
16.1 Static strength of resting seat .18
16.1.1 Requirements for static strength of resting seat .18
16.1.2 Test method for static strength of resting seat .18
16.2 Static strength of the rollator .19
16.2.1 Requirements for static strength of the rollator.19
16.2.2 Test method for static strength of the rollator .19
16.3 Strength of Backrest .19
16.3.1 Requirement for strength of backrest .19
16.3.2 Test method for strength of backrest .20
17 Durability test .20
17.1 Requirement for durability .20
17.2 Test method for durability .20
18 Ergonomic principles .21
19 Packaging .22
20 Information supplied by the manufacturer .22
20.1 General .22
20.2 Information marked on the product .23
20.3 Instruction manual .23
20.4 Test report .24
Annex A (informative) Consideration items for hazards when designing the products .25
Annex B (informative) General recommendations .27
Annex C (informative) Environmental and consumer-related requirements .30
Annex D (informative) Cognitive impairment .35
Bibliography .36
iv © ISO 2020 – All rights reserved
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(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 for persons with
disability.
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:
— corrected the definition of Rollator to conform to the definition described in ISO 9999:2016
(classification no.: 12 06 06)
— added the clause for requirements and test methods for backrest
— added the clauses for relevant general requirements for assistive products for walking based upon
ISO/DIS 21856, ISO 17966, and EN12182
Assistive products for walking manipulated by both arms are covered by the following International
Standards:
— Part 1: Walking frames
— Part 2: Rollators
— Part 3: Walking tables
— ISO 19894: Walking trolleys
These Standards 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.
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(E)
Introduction
A rollator, as defined in ISO 11199-2 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 may 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. In addition to the
requirements in this international standard, Annex B gives general recommendations.
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oSIST prEN ISO 11199-2:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 11199-2:2020(E)
Assistive products for walking, manipulated by both
arms — Requirements and test methods —
Part 2:
Rollators
1 Scope
This part of ISO 11199 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 part of ISO 11199 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 part of ISO 11199 includes rollators
specified for a user mass of no less than 35 kg.
This part of ISO 11199 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 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 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: Genera; requirements
ISO 20417, Information to be provided by the manufacturer
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO/IEC Guide 71, Guide for addressing accessibility in standards
EN 12182, Assistive products for persons with disability. General requirements and test methods
EN 614-1, Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles
3 Terms and definitions
For the purposes of this document, the terms and definitions provided with the following sites apply in
addition to the ones described in this clause.
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(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 http:// www .electropedia .org/
3.1
rollator
Frames which can be moved by pushing or pulling, that enable a person to support full body weight
and to maintain stability and balance while walking and standing with hand grips and three or more
castors/wheels without forearm supports. (See Figure 1)
Note 1 to entry: Double or more castors/wheels used for one pivot position shall be counted as one castor/wheel.
Included are e.g., rollators with a seat for resting, reverse rollators that are pulled with the opening in the front.
Note 2 to entry: ISO 9999 2016, Classification No. 12 06 06
Key
1 rear 6 resting seat
2 brake handle 7 front
3 height adjustment mechanism 8 bracing member
4 folding mechanism 9 wheels
5 handle/handgrip
Figure 1 — Example of Rollator
3.2
maximum user mass
greatest permissible weight of the person using the product declared by the manufacture
3.3
maximum length
maximum outside dimension of a rollator when the adjustments are at their maximum, measured
parallel to the direction of straight forward movement when the rollator is in normal use
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(E)
See Figure 2.
3.4
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
See Figure 2.
3.5
rollator height
vertical distance from the highest point of the handle to the ground surface
See Figure 2.
3.6
turning width
minimum distance between two parallel limiting walls in between which a rollator can be turned 180°
See Figure 2.
Note 1: The adjustments are to be at their maximum.
Key
1 turning width 4 width
2 Width between handles 5 height
3 length
Figure 2 — Dimensions of a rollator
3.7
folded dimensions
height, width and length of the rollator measured with the rollator folded together without the use of tools
3.8
handgrip
that part of the rollator which is intended by the manufacturer to be held by the hand when the rollator
is in use
See Figure 3.
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(E)
3.9
handle
that part of the rollator to which the handgrip is attached
3.10
front handgrip reference point
that point on the upper surface of the handgrip located 30 mm from the front end of the handgrip length
See Figure 3.
3.11
rear handgrip reference point
that point on the upper surface of the handgrip located 30 mm from the rear end of the handgrip length
See Figure 3.
3.12
handgrip length
dimension of the handgrip measured where the hand rests
See Figure 3.
Note 1 to entry: Where the front end or the rear end of the handgrip is not clear, the full length of the handgrip
that may comfortably support the mass of the user is defined as the handgrip length.
3.13
handgrip width
outside dimension of the handgrip measured at the thickest point where the hand rests
See Figure 3.
3.14
brake grip distance
the distance measured, with the brake handle in the neutral position, at the midpoint of the handgrip
length and normal to the centerline of the handle tubing, from the upper surface of the handgrip to the
lower surface of the brake handle
SEE: Figure 4.
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(E)
Key
1 rear handgrip reference point 4 handgrip width
2 front handgrip reference point 5 front
3 handgrip length
Figure 3 — Detailed drawing of a handgrip
Key
1 brake grip distance 3 front handgrip reference point
2 rear handgrip reference point 4 front
Figure 4 — Brake grip distance
3.15
parking brake
a brake that stays engaged after being activated
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(E)
3.16
running brake
a brake that is operated by the user during walking and where the braking effect depends proportionally
on the activation force applied
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
SEE: Figure 5.
Key
1 tyre 3 wheel width
2 0 to 5 mm up from the walking surface
Figure 5 — Wheel width measurement
3.18
resting seat
seat for the user to take a rest
3.19
shopping bag
bag attached on the rollator to carry goods
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
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oSIST prEN ISO 11199-2:2020
ISO/DIS 11199-2:2020(E)
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 may 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, minimu
...
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