SIST EN ISO 11199-1:2021
(Main)Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames (ISO 11199-1:2021)
Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames (ISO 11199-1:2021)
This document specifies requirements and test methods for walking frames used as assistive products
for walking, manipulated by both arms, without accessories, unless specified in the particular test
procedure. This document also gives requirements relating to safety, ergonomics, performance and
information supplied by the manufacturer, including marking and labelling.
The requirements and tests are based on everyday use of walking frames as assistive products for
walking for a maximum user mass as specified by the manufacturer. This document includes walking
frames specified for a user mass of no less than 35 kg.
Hilfsmittel zum Gehen für beidarmige Handhabung - Anforderungen und Prüfverfahren - Teil 1: Gehrahmen (Gehböcke) (ISO 11199-1:2021)
Dieser Teil von ISO 11199 legt Anforderungen und Prüfverfahren für Gehrahmen, die als Gehhilfen 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 Gehrahmen als Gehhilfen für Personen mit einem vom Hersteller festgelegtem Höchstgewicht. Dieser Teil von ISO 11199 schließt Gehrahmen ein, die für Personen mit einem Körpergewicht von mindestens 35 kg bestimmt sind.
Produits d’assistance à la marche manipulés avec les deux bras - Exigences et méthodes d’essai - Partie 1: Cadres de marche (ISO 11199-1:2021)
Le présent document spécifie les exigences et les méthodes d’essai applicables aux cadres de marche utilisés comme produits d’assistance à la marche manipulés par les deux bras, sans accessoires, sauf spécification contraire dans le mode opératoire d’essai particulier. Le présent document spécifie également les exigences en matière de sécurité, d’ergonomie et de performances ainsi que les informations fournies par le fabricant, incluant le marquage et l’étiquetage.
Les exigences et essais reposent sur une utilisation quotidienne des cadres de marche en tant que produits d’assistance à la marche, pour une masse maximale de l’utilisateur telle que spécifiée par le fabricant. Le présent document inclut les cadres de marche spécifiés pour un poids d’utilisateur supérieur à 35 kg.
Pripomočki za hojo, ki se upravljajo z obema rokama - Zahteve in preskusne metode - 1. del: Hodulje (ISO 11199-1:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11199-1:2021
01-september-2021
Nadomešča:
SIST EN ISO 11199-1:2000
Pripomočki za hojo, ki se upravljajo z obema rokama - Zahteve in preskusne
metode - 1. del: Hodulje (ISO 11199-1:2021)
Assistive products for walking manipulated by both arms - Requirements and test
methods - Part 1: Walking frames (ISO 11199-1:2021)
Hilfsmittel zum Gehen für beidarmige Handhabung - Anforderungen und Prüfverfahren -
Teil 1: Gehrahmen (Gehböcke) (ISO 11199-1:2021)
Produits d’assistance à la marche manipulés avec les deux bras - Exigences et
méthodes d’essai - Partie 1: Cadres de marche (ISO 11199-1:2021)
Ta slovenski standard je istoveten z: EN ISO 11199-1:2021
ICS:
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
SIST EN ISO 11199-1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11199-1:2021
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SIST EN ISO 11199-1:2021
EN ISO 11199-1
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2021
EUROPÄISCHE NORM
ICS 11.180.10 Supersedes EN ISO 11199-1:1999
English Version
Assistive products for walking manipulated by both arms -
Requirements and test methods - Part 1: Walking frames
(ISO 11199-1:2021)
Produits d'assistance à la marche manipulés avec les Hilfsmittel zum Gehen für beidarmige Handhabung -
deux bras - Exigences et méthodes d'essai - Partie 1: Anforderungen und Prüfverfahren - Teil 1: Gehrahmen
Cadres de marche (ISO 11199-1:2021) (Gehböcke) (ISO 11199-1:2021)
This European Standard was approved by CEN on 30 April 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11199-1:2021 E
worldwide for CEN national Members.
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SIST EN ISO 11199-1:2021
EN ISO 11199-1:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11199-1:2021
EN ISO 11199-1:2021 (E)
European foreword
This document (EN ISO 11199-1:2021) has been prepared by Technical Committee ISO/TC 173
"Assistive products" in collaboration with Technical Committee CEN/TC 293 “Assistive products and
accessibility” the secretariat of which is held by SIS.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2021, and conflicting national standards
shall be withdrawn at the latest by December 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11199-1:1999.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11199-1:2021 has been approved by CEN as EN ISO 11199-1:2021 without any
modification.
3
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SIST EN ISO 11199-1:2021
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SIST EN ISO 11199-1:2021
INTERNATIONAL ISO
STANDARD 11199-1
Second edition
2021-05
Assistive products for walking
manipulated by both arms —
Requirements and test methods —
Part 1:
Walking frames
Produits d’assistance à la marche manipulés avec les deux bras —
Exigences et méthodes d’essai —
Partie 1: Cadres de marche
Reference number
ISO 11199-1:2021(E)
©
ISO 2021
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SIST EN ISO 11199-1:2021
ISO 11199-1:2021(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 11199-1:2021
ISO 11199-1:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Apparatus . 6
5 Test conditions . 6
6 General requirements and test methods . 7
6.1 Risk analysis . 7
6.2 Walking frames that can be dismantled . 8
6.3 Fasteners . 8
6.4 User mass/Load limits . 8
6.5 Structure requirements . 8
6.6 Brakes . 8
6.6.1 Requirements . 8
6.6.2 Test method . 9
6.7 Handgrip . 9
6.8 Leg section and tip . 9
7 Materials . 9
7.1 General . 9
7.2 Flammability .10
7.3 Biocompatibility and toxicity .10
7.4 Infection and microbiological contamination .10
7.4.1 General.10
7.4.2 Cleaning and disinfection .10
7.5 Resistance to corrosion .10
8 Ingress of liquids .10
9 Temperatures of parts that come in contact with human skin .11
10 Safety of moving parts .11
10.1 Squeezing .11
10.2 Mechanical wear .12
11 Prevention of traps for parts of the human body .12
11.1 Holes and clearances .12
11.2 V-shape openings .12
12 Folding, adjusting and locking mechanisms .12
12.1 General .12
12.2 Folding mechanisms .13
12.3 Locking mechanisms .13
13 Lifting and carrying handles .13
13.1 General .13
13.2 Requirement .13
13.3 Test method .14
14 Surfaces, corners and edges .14
15 Static stability .14
15.1 Requirements for static stability .14
15.2 Test method for static stability .15
15.2.1 General requirement .15
15.2.2 Forward-direction static stability test .15
© ISO 2021 – All rights reserved iii
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SIST EN ISO 11199-1:2021
ISO 11199-1:2021(E)
15.2.3 Rearward-direction static stability test .16
15.2.4 Sideway-direction static stability test .17
16 Static strength .18
16.1 Static strength of walking frame .18
16.1.1 General requirement .18
16.1.2 Requirements for static strength of walking frame .18
16.1.3 Test method for static strength of walking frame .18
16.2 Static strength for the legs with tip .19
16.2.1 General requirement .19
16.2.2 Requirements for static strength of the legs with tip .19
16.2.3 Test method for static strength of the legs with tip .19
17 Durability test .20
17.1 General requirement .20
17.2 Requirement for durability .20
17.3 Test method for durability .20
18 Ergonomic principles .21
19 Packaging .21
20 Information supplied by the manufacturer .21
20.1 General .21
20.2 Information marked on the product .22
20.3 Instruction manual .22
20.4 Test report .23
Annex A (informative) Consideration items for hazards when designing the products .25
Annex B (informative) General recommendations .27
Bibliography .29
iv © ISO 2021 – All rights reserved
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SIST EN ISO 11199-1:2021
ISO 11199-1:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 173, Assistive products, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive
products and accessibility, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 11199-1:1999), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— 3.1 was changed to be in accordance with ISO 9999;
— Clause 6, on general requirements for assistive products for walking, was added.
A list of all parts in the ISO 11199 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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SIST EN ISO 11199-1:2021
ISO 11199-1:2021(E)
Introduction
A walking frame can be used when a person needs assistance when walking. The walking frame can
provide stability when walking and standing and reduce the risk of falling. Walking frames are designed
to support the user inside a frame to carry the user’s full body weight.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 11199-1:2021
INTERNATIONAL STANDARD ISO 11199-1:2021(E)
Assistive products for walking manipulated by both
arms — Requirements and test methods —
Part 1:
Walking frames
1 Scope
This document specifies requirements and test methods for walking frames used as assistive products
for walking, manipulated by both arms, without accessories, unless specified in the particular test
procedure. This document also gives requirements relating to safety, ergonomics, performance and
information supplied by the manufacturer, including marking and labelling.
The requirements and tests are based on everyday use of walking frames as assistive products for
walking for a maximum user mass as specified by the manufacturer. This document includes walking
frames specified for a user mass of no less than 35 kg.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 8191-2, Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source:
match-flame equivalent
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 13732-1, Ergonomics of the thermal environment — Methods for the assessment of human responses to
contact with surfaces — Part 1: Hot surfaces
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical device – Symbols to be used with medical device labels, labelling and information to
be supplied – Part 1: General requirements
ISO 20417, Medical devices — Information to be supplied by the manufacturer
ISO 24415-1, Tips for assistive products for walking — Requirements and test methods — Part 1: Friction
of tips
ISO 7000, Graphical symbols for use on equipment — Registered symbols
EN 614-1+A1, Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
© ISO 2021 – All rights reserved 1
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SIST EN ISO 11199-1:2021
ISO 11199-1:2021(E)
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
brake
device for slowing or stopping motion of a walking frame by contact friction
3.2
front handgrip reference point
position on the upper surface of the handgrip located 30 mm from the front end of the handgrip length
Note 1 to entry: See Figure 1.
3.3
handgrip
part of the walking frame that is intended by the manufacturer to be held by the hand when the walking
frame is in use
Note 1 to entry: See Figure 1.
Key
1 rear handgrip reference point 4 handgrip width
2 front handgrip reference point 5 front
3 handgrip length
Figure 1 — Details of a handgrip
2 © ISO 2021 – All rights reserved
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SIST EN ISO 11199-1:2021
ISO 11199-1:2021(E)
3.4
handgrip length
dimension of the handgrip measured where the hand rests
Note 1 to entry: See Figure 1.
Note 2 to entry: Where the front end or the rear end of the handgrip is not clear, the full length of the handgrip
that can comfortably support the mass of the user is defined as the handgrip length.
3.5
handgrip width
outside dimension of the handgrip measured at the thickest point where the hand rests
Note 1 to entry: See Figure 1.
3.6
handle
part of the walking frame to which the handgrip is attached
3.7
maximum user mass
greatest permissible mass of the person using the product, measured in kilograms (kg)
Note 1 to entry: The maximum user mass is specified by the manufacturer of the walking frame.
3.8
maximum width
maximum outside dimension of a walking frame when the adjustments are at their maximum. measured
horizontally at right angles to the direction of movement when the walking frame is in normal use
Note 1 to entry: See Figure 3.
3.9
parking brake
brake system that is intended for keeping the walking frame stationary on ground after being activated
3.10
pressure brake
running brake that engages when a vertical load is applied on the handgrips or on supporting points of
the walking frame
Note 1 to entry: See Figure 2
Key
1 wheel 4 rubber tip (brake)
2 spring 5 brake pad
3 frame
Figure 2 — Two types of pressure brake with technical details
© ISO 2021 – All rights reserved 3
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SIST EN ISO 11199-1:2021
ISO 11199-1:2021(E)
3.11
rear handgrip reference point
position on the upper surface of the handgrip located 30 mm from the rear end of the handgrip length
Note 1 to entry: See Figure 1.
Note 2 to entry: If the grip protrudes further than the handle, the measurement is made from the end of the
handle.
3.12
reciprocal walking frame
walking frame where each side of the frame moves alternately, allowing unilateral forward progression
through the whole gait cycle
3.13
running brake
brake that is operated by the user during walking and where the braking effect depends proportionally
on the activation force applied
3.14
tip
part of a walking frame that is in contact with the ground
3.15
turning diameter
diameter of the largest circle described by a walking frame when the adjustments are at their maximum
and walking frame is turned through 360° about its own central vertical axis
Note 1 to entry: See Figure 3.
Key
1 width between handles 4 turning diameter
2 height 5 length
3 width
Figure 3 — Dimensions of a walking frame
4 © ISO 2021 – All rights reserved
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SIST EN ISO 11199-1:2021
ISO 11199-1
...
SLOVENSKI STANDARD
oSIST prEN ISO 11199-1:2020
01-september-2020
Pripomočki za hojo, ki se upravljajo z obema rokama - Zahteve in preskusne
metode - 1. del: Sprehajalni okvirji (ISO/DIS 11199-1:2020)
Assistive products for walking, manipulated by both arms - Requirements and test
methods - Part 1: Walking frames (ISO/DIS 11199-1:2020)
Mit beiden Armen gehandhabte Gehhilfen - Anforderungen und Prüfverfahren - Teil 1:
Gehrahmen (Gehböcke) (ISO/DIS 11199-1:2020)
Aides à la marche manipulées avec les deux bras - Exigences et méthodes d'essai -
Partie 1: Cadres de marche (ISO/DIS 11199-1:2020)
Ta slovenski standard je istoveten z: prEN ISO 11199-1
ICS:
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
oSIST prEN ISO 11199-1:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11199-1:2020
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oSIST prEN ISO 11199-1:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11199-1
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 1:
Walking frames
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 11199-1:2020(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 11199-1:2020
ISO/DIS 11199-1:2020(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
---------------------- Page: 4 ----------------------
oSIST prEN ISO 11199-1:2020
ISO/DIS 11199-1:2020(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 . 7
6.1 Risk analysis . 7
6.2 Walking frames that can be dismantled . 8
6.3 Fasteners . 8
6.4 User mass/Load limits . 8
6.5 Structure requirements . 8
6.6 Brakes . 8
6.6.1 Requirements of brakes . 8
6.6.2 Test method of brakes . 9
6.7 Handgrip . 9
6.8 Leg section and tip . 9
7 Materials . 9
7.1 General . 9
7.2 Flammability .10
7.3 Biocompatibility and toxicity .10
7.4 Infection and microbiological contamination .10
7.4.1 General.10
7.4.2 Cleaning and disinfection .10
7.5 Resistance to corrosion .10
8 Ingress of liquids .10
9 Temperatures of parts that come in contact with human skin .11
10 Safety of moving parts .11
10.1 Squeezing .11
10.2 Mechanical wear .12
11 Prevention of traps for parts of the human body .12
11.1 Holes and clearances .12
12 Folding, adjusting and locking mechanisms .13
12.1 General .13
12.2 Folding mechanisms .13
12.3 Locking mechanisms .13
13 Lifting and carrying handles .13
13.1 General .13
13.2 Requirement .14
13.3 Test method .14
14 Surfaces, corners and edges .14
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 11199-1:2020
ISO/DIS 11199-1:2020(E)
16 Static strength .18
16.1 Static strength of walking frame .18
16.1.1 Requirements for static strength of walking frame .18
16.1.2 Test method for static strength of walking frame .18
16.2 Static strength for the legs with tip .19
16.2.1 Requirements for static strength of the legs with tip .19
16.2.2 Test method for static strength of the legs with tip .19
17 Durability test .20
17.1 Requirement for durability .20
17.2 Test method for durability .20
18 Ergonomic principles .20
19 Packaging .21
20 Information supplied by the manufacturer .21
20.1 General .21
20.2 Information marked on the product .22
20.3 Instruction manual .22
20.4 Test report .23
Annex A (informative) Consideration items for hazards when designing the products .25
Annex B (informative) General recommendations .27
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 11199-1:2020
ISO/DIS 11199-1:2020(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 second edition cancels and replaces the first edition (ISO 11199-1:1999), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— corrected the definition of Walking frames to conform to the definition described in ISO 9999:2016
(classification no.: 12 06 03)
— 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:
— ISO 11199-Part 1: Walking frames
— ISO 11199-Part 2: Rollators
— ISO 11199-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 11199-1:2020
ISO/DIS 11199-1:2020(E)
Introduction
A walking frame, as defined in ISO 11199-1 can be used when a person needs assistance when walking.
The walking frame can provide stability when walking and standing and reduce the risk of falling.
Walking Frames are designed to support the user inside a frame to carry the user’s full body weight. In
addition to the requirements in this international standard, Annex B gives general recommendations
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oSIST prEN ISO 11199-1:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 11199-1:2020(E)
Assistive products for walking, manipulated by both
arms — Requirements and test methods —
Part 1:
Walking frames
1 Scope
This part of ISO 11199 specifies requirements and test methods of walking frames being used as
assistive products for walking, 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 walking frames as assistive products for
walking for a maximum user mass as specified by the manufacturer. This part of ISO 11199 includes
walking frames specified for a user mass of no less than 35 kg.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 8191-2, Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source:
match-flame equivalent
ISO 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
EN 1041, Information supplied by the manufacturer of medical devices
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 11199-1:2020
ISO/DIS 11199-1:2020(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
Walking frame
Frames which a person lifts to move, that enables to support full body weight and to maintain stability
and balance while walking or standing with hand grips, without forearm supports and with either four
tips or two tips and two castors/wheels. (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., rigid or articulated walking frames assistive products for walking with two wheels combination
with two rubber stick buffers/tips.
Note 2 to entry: ISO 9999 2016, Classification No. 12 06 03
Key
1 front 5 rear
2 front legs 6 rear legs
3 bracing members 7 head adjustment mechanism
4 handgrip 8 tips
Figure 1 — Example of walking frame
3.2
Folded dimensions
height, width and length of the walking frame measured with the frame folded together without the use
of tools.
3.3
frame height
vertical distance from the highest point of the walking frame to the ground surface.See Figure 2.
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ISO/DIS 11199-1:2020(E)
Key
1 width between handles 4 turning diameter
2 height 5 length
3 width
Figure 2 — Dimensions of a walking frame
3.4
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.
Key
1 rear handgrip reference point 4 handgrip width
2 front handgrip reference point
3 handgrip length
Figure 3 — Details of a handgrip
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3.5
handgrip
that part of the walking frame which is intended by the manufacturer to be held by the hand when the
walking frame is in use.
3.6
handgrip length
dimension of the handgrip measured where the hand rests.
See Figure 3.
Note 1: Where the front end or the rear end of the handgrip is not clear, the full length of the handgrip
that can support the weight of the user is defined as the handgrip length.
3.7
handgrip width
outside dimension of the handgrip measured at the thickest point where the hand rests.
See Figure 3.
3.8
handle
that part of the walking frame to which the handgrip is attached.
3.9
maximum length
maximum outside dimension of a walking frame when the adjustments are at their maximum. measured
parallel to the direction of straight forwards movement when the walking frame is in normal use.
See Figure 2.
3.10
maximum width
maximum outside dimension of a walking frame when the adjustments are at their maximum. measured
horizontally at right angles to the direction of movement when the walking frame is in normal use.
See Figure 2.
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.
Note 1 to entry: If the grip protrudes further than the handle, the measurement is made from the end of the handle.
3.12
tip
that part of a walking frame which is in contact with the ground.
3.13
glide tip
that part of a walking frame which is in contact with the ground and are supposed to slide on the surface
when the walking frame is moved.
3.14
turning diameter
diameter of the largest circle described by a walking frame when the adjustments are at their maximum
and walking frame is turned through 360° about its own central vertical axis.
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See Figure 2.
3.15
maximum user mass
greatest permissible weight of the person using the product declared by the manufacturer.
3.16
parking brake
a brake that stays engaged after being activated.
3.17
running brake
a brake that is operated by the user during walking and where the braking effect depends proportionally
on the activation force applied.
3.18
pressure brake
a running brake that engages when a vertical load is applied on the handgrips or on supporting points
of the walking frame. See Figure 4.
Key
1 wheel 4 rubber tip (brake)
2 spring 5 brake pad
3 frame
Figure 4 — Two types of pressure brake with technical details
3.19
wheel width
maximum dimension of the tyre of the wheel measured within 5 mm up from the walking surface when
the walking frame is unloaded. See Figure 5.
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Key
1 tyre 3 wheel width
2 0 to 5 mm up from the walking surface
Figure 5 — Wheel width measurement
3.20
reciprocal walking frame
a walking frame where each side of the frame moves alternately, allowing unilateral forward
progression through the whole gait cycle.
4 Apparatus
4.1 Means to apply a force with an accuracy of ± 5 % and with a rate of application less than 1 N/s.
4.2 Means to measure force with an accuracy of ± 5 % in increments of 1 N.
4.3 Means to measure distance in the range of 0 m to 3 m with an accuracy of ± 5 mm or ± 2 %
whichever is the greater
4.4 Means to measure angles to an accuracy of ± 0,5°.
4.5 Means to measure torque with an accuracy of ± 5 % in increments of 1 Nm in the range of 0,5 Nm
to 10 Nm
4.6 A test plane of sufficient size and stiffness to support the walking frame during testing, such that
the whole surface is contained between two imaginary parallel planes 5 mm a part. The test plane 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 walking frame from moving during testing,
without interfering with the test or the walking frame
4.8 Equipment for measuring pressure of air with an accuracy of ± 5 %
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5 Test conditions
a) The tests shall be performed at an ambient temperature of 21°C ±5°C.
b) Adjustable parts of the walking frame shall be adjusted to the most adverse position according to
manufacturer’s instruction unless otherwise specified in the test procedure.
c) The Swivelling wheels shall be positioned as if the walking frame is run forward as far as a condition
is not specified in the test procedure.
d) The handles shall be positioned at their maximum distance and maximum angles to provide the
most adverse configuration as specified by the manufacturer as far as a condition is not specified
in the test procedure. When the longitudinal centreline of the handle and the direction of forward
motion are parallel, the angle is 0°. The angle shall always be recorded.
e) The running b
...
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