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EN IEC 80601-2-78:2020

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:   Oct 14, 2020

General information

60.60 Standard published   Apr 3, 2020

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

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
EN IEC 80601-2-78:2020
60.60 Standard published
Apr 3, 2020

CORRIGENDA / AMENDMENTS

PUBLISHED
EN IEC 80601-2-78:2020/A1:2024

REVISED BY

IN_DEVELOPMENT
prEN IEC 80601-2-78