BS EN IEC 80601-2-78:2020

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

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Standard number:	BS EN IEC 80601-2-78:2020
Pages:	82
Released:	2020-04-06
ISBN:	978 0 580 96579 1
Status:	Standard

DESCRIPTION

BS EN IEC 80601-2-78:2020

This standard BS EN IEC 80601-2-78:2020 Medical electrical equipment is classified in these ICS categories:

11.040.01 Medical equipment in general

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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