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IEC 80601-2-78:2019 ED1

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

Publication date:   Mar 12, 2024

General information

60.60 Standard published   Jul 9, 2019

IEC

TC 62/SC 62D

International Standard

11.040.01   Medical equipment in general

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Scope

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).

Life cycle

NOW

PUBLISHED
IEC 80601-2-78:2019 ED1
60.60 Standard published
Jul 9, 2019

CORRIGENDA / AMENDMENTS

PUBLISHED
IEC 80601-2-78:2019/AMD1:2024 ED1

REVISED BY

IN_DEVELOPMENT
IEC 80601-2-78 ED2