EN ISO 11199-1:1999
(Main)Walking aids manipulated by both arms - Requirements and test methods - Part 1: Walking frames (ISO 11199-1:1999)
Walking aids manipulated by both arms - Requirements and test methods - Part 1: Walking frames (ISO 11199-1:1999)
Gehhilfen für beidarmige Handhabung - Anforderungen und Prüfverfahren - Teil 1: Gehböcke (ISO 11199-1:1999)
Dieser Teil der ISO 11199 legt die Anforderungen und Verfahren für die Ermüdungsprüfung, die Prüfung der statischen Beanspruchbarkeit und Kippsicherheit für Gehböcke ohne Zubehör fest, sofern es nicht in speziellen Prüfverfahren anders festgelegt wird. Dieser Teil der ISO 11199 enthält ebenfalls Anforderungen für Sicherheit, Ergonomie, Leistungsfähigkeit, Kennzeichnung und Aufschriften. Die Anforderungen und Prüfungen beruhen auf dem alltäglichen Gebrauch von Gehböcke, die für Personen mit einem Körpergewicht von mindestens 35 kg vorgesehen sind.
Aides à la marche manipulées avec les deux bras - Exigences et méthodes d'essai - Partie 1: Cadres de marche (ISO 11199-1:1999)
La présente partie de l'ISO 11199 spécifie les exigences et méthodes d'essai relatives à la résistance à la fatigue, à la capacité de charge statique et à la stabilité des cadres de marche sans accessoires, à moins que cela ne soit spécifié dans une procédure d'essai particulière. La présente partie de l'ISO 11199 spécifie également les exigences en matière de sécurité, d'ergonomie, de performances, de marquage et d'étiquetage. Les exigences et les essais sont basés sur un usage quotidien des cadres de marche conçus pour un utilisateur ayant un poids (une masse) de 35 kg au moins.
NOTE L'annexe A contient des recommandations relatives aux exigences contenues dans la présente partie de l'ISO 11199.
Pripomočki za hojo, ki se upravljajo z obema rokama - Zahteve in preskusne metode - 1. del: Sprehajalni okvirji (ISO 11199-2:1999)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2000
3ULSRPRþNL]DKRMRNLVHXSUDYOMDMR]REHPDURNDPD=DKWHYHLQSUHVNXVQH
PHWRGHGHO 6SUHKDMDOQLRNYLUML ,62
Walking aids manipulated by both arms - Requirements and test methods - Part 1:
Walking frames (ISO 11199-1:1999)
Gehhilfen für beidarmige Handhabung - Anforderungen und Prüfverfahren - Teil 1:
Gehböcke (ISO 11199-1:1999)
Aides a la marche manipulées avec les deux bras - Exigences et méthodes d'essai -
Partie 1: Cadres de marche (ISO 11199-1:1999)
Ta slovenski standard je istoveten z: EN ISO 11199-1:1999
ICS:
11.180.10 3ULSRPRþNLLQSULODJRGLWYH]D Aids and adaptation for
JLEDQMH moving
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
INTERNATIONAL ISO
STANDARD 11199-1
First edition
1999-08-01
Walking aids manipulated by both arms —
Requirements and test methods —
Part 1:
Walking frames
Aides à la marche manipulées avec les deux bras — Exigences et
méthodes d'essai —
Partie 1: Cadres de marche
A
Reference number
ISO 11199-1:1999(E)
ISO 11199-1:1999(E)
Contents
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Requirements.4
5 Test methods.6
6 Marking and labelling .12
7 Test report .12
Annex A (informative) Recommendations.13
© ISO 1999
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
ii
© ISO
ISO 11199-1:1999(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
International Standard ISO 11199-1 was prepared by Technical Committee ISO/TC 173, Technical systems and
aids for disabled or handicapped persons.
ISO 11199 consists of the following parts, under the general title Walking aids manipulated by both arms —
Requirements and test methods:
Part 1: Walking frames
Part 2: Rollators
Annex A of this part of ISO 11199 is for information only.
iii
INTERNATIONAL STANDARD © ISO ISO 11199-1:1999(E)
Walking aids manipulated by both arms — Requirements and test
methods —
Part 1:
Walking frames
1 Scope
This part of ISO 11199 specifies requirements and methods of testing fatigue, static load capacity and stability of
walking frames without accessories, unless specified in the particular test procedure. This part of ISO 11199 also
gives the requirements relating to safety, ergonomics, performance, marking and labelling.
The requirements and tests are based on everyday usage of walking frames manufactured for a user mass of not
less than 35 kg.
NOTE Recommendations further to the requirements given in this part of ISO 11199 are given in annex A.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 11199. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 11199 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 9999:1998, Technical aids for disabled persons — Classification.
ISO 10933-1, .
Biological evaluation of medical devices — Part 1: Evaluation and testing
3 Terms and definitions
For the purposes of this part of ISO 11199, the following terms and definitions apply (see also Figures 1, 2 and 3).
3.1
folded dimensions
height, width and length of the walking frame measured with the frame folded together without the use of tools, the
height adjustment at its minimum height and the handles positioned as in 5.1.
3.2
frame height
vertical distance from the rear handgrip reference point to the ground
See Figure 3.
© ISO
ISO 11199-1:1999(E)
3.3
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 2.
3.4
handgrip
that part of the walking frame which is normally held by the hand when the frame is in use
3.5
handgrip length
dimension of the handgrip measured longitudinally where the hand rests
See Figure 2.
NOTE 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.
3.6
handgrip width
outside dimension of the handgrip measured horizontally at the thickest point where the hand rests
See Figure 2.
3.7
handle
that part of the walking frame to which the handgrip is attached.
3.8
maximum length
maximum outside dimension of a walking frame when the height adjustment is at its maximum, measured parallel to
the direction of movement when the frame is in normal use
See Figure 3.
3.9
maximum width
maximum outside dimension of a walking frame when the height adjustment is at its maximum, measured
horizontally at right angles to the direction of movement when the frame is in normal use
See Figure 3.
3.10
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 2.
NOTE If the grip protrudes further than the handle, the measurement is made from the end of the handle.
3.11
tip
that part of a walking frame which is in contact with the ground
3.12
turning diameter
diameter of the largest circle described by a walking frame when the height adjustment is at its maximum and the
walking frame is turned through 360° about its own central vertical axis
See Figure 3.
© ISO
ISO 11199-1:1999(E)
3.13
user weight
body mass of the person using the product as a technical aid
NOTE Standard user weight is 100 kg for adults and 35 kg for children.
3.14
walking frame
walking aid without wheels and with no support devices other than handles
NOTE Classification No. 12 06 03 in accordance with ISO 9999:1998.
Key
1 Front
2 Front legs
3 Bracing members
4 Handgrip
5 Rear
6 Rear legs
7 Head adjustment mechanism
8 Tip
Figure 1 — Example of a walking frame
© ISO
ISO 11199-1:1999(E)
Dimensions in millimetres
Key
Rear handgrip reference point
Front handgrip reference point
3 Handgrip length
4 Handgrip width
Figure 2 — Details of a handgrip
4 Requirements
4.1 Mechanical durability
When tested according to the fatigue test (5.3), no part of the walking frame shall crack or break.
When tested according to the static loading test (5.4), no part of the frame shall crack or break.
When tested according to the static leg-strength test (5.5), none of the legs shall crack, break or show any
permanent set of more than 15 mm, measured at the end of the leg.
4.2 Stability
When tested according to the forward stability test (5.6), the angle of the plane at the point of walking frame tilting
shall be not less than 10,0°.
When tested according to the backward stability test (5.7), the angle of the plane at the point of walking frame tilting
shall be not less than 7,0°.
When tested according to the sideways stability test (5.8), the angle of the plane at the point of walking frame tilting
shall be not less than 3,5°.
It is acknowledged that a reciprocal walking frame cannot meet this sideways stability requirement. Therefore, an
analysis of the risks related to the instability shall be assessed by the manufacturer, and appropriate guidance and
warnings on limitations for use shall be given.
© ISO
ISO 11199-1:1999(E)
Key
1 Width between handles
Height
3 Width
4 Turning diameter
5 Length
Figure 3 — Dimensions of a walking frame
4.3 Manoeuvrability
Maximum width of a walking frame manufactured for use in private homes shall be not larger than 650 mm.
The width of reciprocating walking frames, when reciprocated, shall be not less than 90 % of maximum width.
4.4 Handgrip
The handgrip width shall be not less than 20 mm and not more than 50 mm.
NOTE This requirement does not apply to anatomic handgrips.
The handgrip shall be replaceable or easy to clean.
© ISO
ISO 11199-1:1999(E)
4.5 Leg section and tip
The leg section shall end in a tip of a design which will prevent the leg section from piercing through it when used as
intended by the manufacturer. See also 4.1.
The tip shall be replaceable.
The tip shall not cause discolouring of the walking surface, as verified by visual inspection.
That part of the tip that contacts the walking surface shall have a minimum diameter of 35 mm. Compliance shall be
verified by visual inspection.
4.6 Adjusting devices
Each of the height adjustments shall be clearly marked with its maximum allowable elongation.
After the fatigue test (5.3), the adjustment/folding mechanisms shall operate as intended by the manufacturer.
Folding walking frames shall lock into working position when unfolded.
4.7 Materials and finish
Taking into account the intended use and contact by those involved in user care or transportation and storage of the
product, walking frame materials which come into contact with the human body shall be assessed for
biocompatibility using the guidance given in ISO 10993-1.
The walking frame materials shall not cause discolouring of skin or clothing when the frame is in normal use.
All parts of the walking frame shall be free from burrs, sharp edges or projections that could cause damage to
clothing or discomfort to the user.
5 Test methods
5.1 General
Walking frames are grouped into six sizes, as given in Table A.1.
All tests, if not otherwise specified, shall be performed at an ambient temperature of 21 °C ± 5 °C.
If not otherwise specified, all tests shall be performed with the height adjustments at their maximum. The handles
shall be positioned at their maximum angle as specified by the manufacturer relative to the line of motion. 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.
5.2 Sampling and inspection
One walking frame shall be tested. The sequence of the tests shall be as follows: stability, static load, fatigue and
static leg-strength.
Immediately before testing, the walking frame shall be inspected to check compliance with this part of ISO 11199.
Any apparent defects shall be noted so that they shall not later be recorded as having been caused by the tests.
5.3 Fatigue test
5.3.1 Loading geometry
The height adjustment and the handles shall be positioned as given in 5.1 and the frame shall be placed with its tips
on a horizontal surface.The loading force shall be applied vertically to the walking frame as shown in Figure 4. The
loading line shall pass through the midpoint of the line joining the rear handgrip reference points of the two
handgrips.
© ISO
ISO 11199-1:1999(E)
5.3.2 Loading force
A cyclic force of 800 N ± 2 % shall be applied. If the maximum user weight specified for the frame deviates from the
standard maximum user weight of 100 kg, a force of 8,0 N per kilogram of maximum user weight, ± 2 %, shall be
applied. The load shall be not less than 280 N ± 2 %.
5.3.3 Loading frequency
The frequency of the cyclic loading shall not exceed 1 Hz.
5.3.4 Loading cycles
The number of cycles shall be 200 000.
5.4 Static loading test
5.4.1 Loading g
...
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