IEC-80601-2-78 › Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

IEC-80601-2-78 - EDITION 1.0 - CURRENT


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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).
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Document Number

IEC 80601-2-78 Ed. 1.0 b:2019

Revision Level

EDITION 1.0

Status

Current

Publication Date

July 1, 2019

Committee Number

62d