FprEN ISO 11199-2

Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO/FDIS 11199-1:2021)

Technische Hilfen zum Gehen für beidarmige Handhabung - Anforderungen und Prüfverfahren - Teil 2: Rollatoren (ISO/FDIS 11199-2:2021)

Dieses Dokument legt Anforderungen und Prüfverfahren für Rollatoren ohne Zubehör, die als Technische Hilfen zum Gehen (Gehhilfen) mit Rädern genutzt und mit beiden Armen gehandhabt werden, fest, sofern es in dem bestimmten Prüfverfahren nicht anders festgelegt ist. Dieses Dokument enthält außerdem Anforderungen bezüglich der Sicherheit, Ergonomie und Leistungsfähigkeit und der vom Hersteller bereitzu-stellenden Informationen, einschließlich Kennzeichnung und Aufschriften.
Die Anforderungen und Prüfungen beruhen auf dem alltäglichen Gebrauch von Rollatoren als Technische Hilfen zum Gehen für Personen mit einem vom Hersteller festgelegtem Höchstgewicht. Dieses Dokument schließt Rollatoren ein, die für Personen mit einem Körpergewicht von mindestens 35 kg bestimmt sind.
Dieses Dokument ist nicht für Rollatoren mit waagerechten Unterarmstützen, die als Gehwagen eingeteilt sind und für die ISO 11199-3 gilt, anzuwenden.

Produits d’assistance à la marche manipulés avec les deux bras - Exigences et méthodes d’essai - Partie 2: Déambulateurs (ISO/FDIS 11199-1:2021)

Pripomočki za hojo, ki se upravljajo z obema rokama - Zahteve in preskusne metode - 2. del: Rolatorji (ISO/FDIS 11199-2:2021)

General Information

• Status: Not Published
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293/WG 1 - Walking aids
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Due Date: 12-Jun-2021
• Completion Date: 12-Jun-2021
• Ref Project: kSIST FprEN ISO 11199-2:2021 - Assistive products for walking, manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO/FDIS 11199-2:2021)

RELATIONS

• Revised: EN ISO 11199-2:2005 - Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2005)
• Effective Date: 06-Feb-2019

Standards Content (sample)

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
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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

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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

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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
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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
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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
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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
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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

...