Medical Electrical Equipment - Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Scope:
This Standard applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS following an IMPAIRMENT.
This particular standard does not apply to:
- (external limb) prosthetic devices (use: ISO 22523)
- Electric wheelchairs (use: ISO 7176 series)
- Diagnostic imaging equipment (e.g. MRI, use: IEC 60601-2-33)
- Personal care robots (use: ISO 13482)
Project need:
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Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.