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.