ISO 5363:2024

International
Standard
ISO 5363
First edition
Robotics — Test methods for
2024-04
exoskeleton-type walking RACA robot
Robotique — Méthodes d'essai du robot ambulant RACA de type
exosquelette
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test conditions . 2
4.1 General .2
4.2 Environmental conditions . .2
4.3 Apparatus .2
4.3.1 Construction of test equipment .2
4.3.2 Treadmill .3
4.3.3 Test dummy .4
4.3.4 Test frame .4
4.3.5 Actuation module .5
4.4 Example of test setup.5
5 Accuracy test of range of movement of each joint of walking RACA robot . 6
5.1 Purpose .6
5.2 Procedure .6
6 Repeated durability test of actuated applied part. 6
6.1 Purpose .6
6.2 Procedure .7
7 Repeated durability test of support system of walking RACA robot . 7
7.1 Purpose .7
7.2 Procedure .7
8 Test report . 8
Annex A (informative) Theoretical background of the repeated durability test of support
systems of walking RACA robot .10
Annex B (Informative) Horizontal test set up for the repeated durability test of support systems
of walking RACA robot . .12
Bibliography . 14

iii
Foreword
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In the IEC, see www.iec.ch/understanding-standards.
This document was prepared jointly by Technical Committee ISO/TC 299, Robotics, and Technical Committee
IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC 62A, Common aspects of medical
equipment, software, and systems and Subcommittee SC 62D, Particular medical equipment, software, and
systems.
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 and
www.iec.ch/national-committees.

iv
Introduction
When IEC 80601-2-78:2019 was published there were no specific test methods to verify the conformity with
the standard. This document was developed to supplement IEC 80601-2-78:2019 by specifying test methods
to evaluate powered exoskeleton-type walking RACA robots.

v
International Standard ISO 5363:2024(en)
Robotics — Test methods for exoskeleton-type walking
RACA robot
1 Scope
This document specifies test methods for the exoskeleton-type walking RACA robot used as medical
electrical equipment which is intended to move from one location to another, by making reciprocating
motion having intermittent contact with the travel surface.
This document does not apply to passive or non-powered exoskeletons.
NOTE These tests can be used to verify conformity with the requirements of IEC 80601-2-78.
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.
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements for
basic safety and essential performance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
actuated applied part
subcategory of applied part that is intended to provide actively controlled physical interactions with the
patient that are related to the patient’s movement functions, to perform a clinical function of a RACA robot
[SOURCE: IEC 80601-2-78:2019, 201.3.201]
3.2
medical robot
robot intended to be used as medical electrical equipment or medical electrical system
[SOURCE: IEC/TR 60601-4-1:2017, 3.20]
3.3
RACA robot
rehabilitation, assessment, compensation and alleviation robot
medical robot intended by its manufacturer to perform rehabilitation, assessment, compensation or
alleviation comprising an actuated applied part
[SOURCE: IEC 80601-2-78:2019, 201.3.212]

3.4
robot
programmed actuated mechanism with a degree of autonomy to perform locomotion, manipulation or
positioning
[SOURCE: ISO 8373:2021, 3.1]
3.5
walking
mobile equipment that, once installed and placed into service, is intended to move from one location to another,
by making reciprocating motion having intermittent contact with the travel surface and the RACA robot
[SOURCE: IEC 80601-2-78:2019, 201.3.215]
4 Test conditions
4.1 General
The exoskeleton-type walking RACA robot shall be completely assembled, fully charged and operational. It
should also be ensured that the robot operates in a safe manner throughout the test.
The tests shall be preceded by the preparations for operation as specified by the manufacturer.
4.2 Environmental conditions
The following environmental conditions shall be maintained during all tests.
— Ambient temperature: 5 °C to 40 °C
— Relative humidity: 15 % to 90 %
If the environmental conditions specified by the manufacturer are outside the given conditions, then this
shall be declared in the test results.
4.3 Apparatus
4.3.1 Construction of test equipment
The test apparatus consists of the following parts (see Figure 1):
— force sensor to measure floor reaction force;
— actuation module to vertically move the dummy with position control, speed control and force control;
— treadmill to simulate the reciprocating motion;
— test dummy to be attached with RACA robot.
Walking RACA robot shall be installed into the test apparatus.

Key
1 treadmill
2 test frame
3 test dummy
4 force sensor
5 actuation module
Figure 1 — Construction of test equipment
4.3.2 Treadmill
4.3.2.1 Belt speed
The belt speed shall have an accuracy specified by treadmill manufacturer. The belt speed should be able to
be controlled in conjunction with the vertical movement of the actuation module.
When the belt speed needs to be controlled by interfacing with the exoskeleton-type walking RACA robot,
it should have an input/output terminal of a signal that can be synchronized with the exoskeleton-type
walking RACA robot.
4.3.
...