ISO 5363:2024

Name: ISO 5363:2024 — Robotics — Test methods for exoskeleton-type walking RACA robot
SKU: ISO 5363:2024
Price: 25 EUR
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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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Цена:25 €

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

Overview

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.

Технические детали

Технический комитет: ISO/TC 299 - Robotics
SKU: ISO 5363:2024

Главная

Каталог

IEC 80601-2-78:2019

Действующий

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance…

Overview IEC 80601-2-78:2019 is an international standard published by the International Electrotechnical Commission (IEC) that specifies particular requirements for the basic safety and essential pe…

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IEC 60601-1-12:2014

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Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - C…

Overview IEC 60601-1-12:2014 is an international collateral standard under the IEC 60601-1 series, developed by the International Electrotechnical Commission (IEC). This standard sets forth general r…

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ISO 8373:2021

Действующий

Robotics — Vocabulary

Overview ISO 8373:2021 - Robotics - Vocabulary is the third-edition ISO standard that provides a harmonized vocabulary for robotics. Its primary purpose is to define terms used in relation to robots,…

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ISO 7250-3:2015

Действующий

Basic human body measurements for technological design — Part 3: Worldwide and regional design ranges for use…

Overview ISO 7250-3:2015 - Basic human body measurements for technological design - Part 3 provides worldwide and regional design ranges of anthropometric dimensions for use in product standards. It…

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ISO 5363:2024

Abstract

Overview

Похожие стандарты

Key technical topics and requirements

Practical applications and who uses ISO 5363:2024

Related standards

Технические детали

IEC 80601-2-78:2019

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance…

IEC 60601-1-12:2014

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - C…

ISO 8373:2021

Robotics — Vocabulary

ISO 7250-3:2015

Basic human body measurements for technological design — Part 3: Worldwide and regional design ranges for use…