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IEC 80601-2-78:2019

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IEC 80601-2-78:2019

Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

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IEC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT?S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
IEC 80601-2-78:2019 does not apply to
? external limb prosthetic devices (use ISO 22523),
? electric wheelchairs (use ISO 7176 (all parts)),
? diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and
? personal care ROBOTS (use ISO 13482).

Author ISO/TC 299 Robotics
Editor ISO
Document type Standard
Format Paper
Edition 1
Number of pages 144
Weight(kg.) 0.3448
Year 2019
Country Switzerland