ISO 5363:2024 PDF

Name: ISO 5363:2024 — Robotics — Test methods for exoskeleton-type walking RACA robot
SKU: ISO 5363:2024
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Robotics — Test methods for exoskeleton-type walking RACA robot

Название (английский):

ISO 5363:2024

Robotics — Test methods for exoskeleton-type walking RACA robot

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 14
Дата публикации:: 19 апреля 2024 г.
Издание:: ISO IS 5363 edition 1 version 1
ICS:: 11.180.10

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Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 5363:2024 - Robotics - Test methods for exoskeleton‑type walking RACA robot specifies standardized test methods for powered exoskeleton‑type walking RACA robots used as medical electrical equipment. The standard covers test set‑up, environmental conditions, required apparatus and procedures to evaluate functional performance and mechanical durability of exoskeleton‑type RACA robots that move by reciprocating motion with intermittent contact with the travel surface. It explicitly excludes passive or non‑powered exoskeletons. These test methods can be used to verify conformity with IEC 80601‑2‑78.

Key technical topics and requirements

Scope and definitions: Clarifies terms such as RACA robot (rehabilitation, assessment, compensation and alleviation robot), actuated applied part, walking, and medical robot consistent with IEC and ISO terminology.

Test conditions and environmental limits: Tests are performed with the robot fully assembled, charged and operable; ambient temperature 5 °C to 40 °C and relative humidity 15 % to 90 % (unless manufacturer specifies otherwise).

Required apparatus and test set‑up:

Treadmill: belt speed control/synchronization with the robot; permissible load must support patient mass + robot + accessories.
Test dummy: passive dummy with movable hip, knee, ankle joints sized per IEC/ISO anthropometric references.
Test frame: rigid, floor‑fixed frame with sufficient height to mount the robot on the dummy over the treadmill.
Actuation module: powered vertical motion to lift the dummy in coordination with gait; vertical range of 100 mm or more and speed interlock with treadmill/robot.
Force sensor and instrumentation for motion/force measurement.

Performance tests:

Accuracy test of joint range of movement: measures joint angle ranges during gait (e.g., using a 3D optical motion analyser or electric goniometer); performance specs are manufacturer‑defined and measured under worst‑case conditions (max load, speed, gait length).
Repeated durability tests: fatigue/durability testing of actuated applied parts and support systems to validate mechanical life between inspections.

Documentation: specified test report content and informative annexes on theoretical background and alternate test set‑ups.

Practical applications and who uses ISO 5363:2024

Exoskeleton manufacturers - design validation, product development and pre‑market verification.

Test laboratories and conformity assessors - standardized procedures for performance and durability testing.

Regulatory bodies and certification organizations - objective methods to assess compliance with IEC 80601‑2‑78 and medical device safety requirements.

Clinical engineering and procurement teams - evidence‑based evaluation of exoskeleton durability and functional accuracy before clinical adoption.

Related standards

IEC 80601‑2‑78 (medical electrical equipment - specific requirements for RACA robots)

IEC 60601‑1 (general requirements for basic safety and essential performance)

ISO 8373, ISO/IEC terminology and anthropometric references (e.g., IEC 60601‑1 annexes, ISO 7250 series)

Keywords: ISO 5363:2024, exoskeleton, RACA robot, test methods, medical electrical equipment, joint range accuracy, durability test, treadmill test, IEC 80601‑2‑78.

ISO 5363:2024 PDF

Abstract

Похожие стандарты

Overview

Key technical topics and requirements

Practical applications and who uses ISO 5363:2024

Related standards

Технические детали

BS EN IEC 80601-2-78:2020

Medical electrical equipment - Particular requirements for basic safety and essential performance of medical…

IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

ISO 8373:1994/Cor 1:1996

Manipulating industrial robots — Vocabulary — Technical Corrigendum 1

SIST EN ISO 7250-1:2018

Basic human body measurements for technological design - Part 1: Body measurement definitions and landmarks (…