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IEC 80601-2-78 Ed. 1.1 b:2024

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 Ed. 1.1 b:2024

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

PUBLISH DATE 2024
IEC 80601-2-78 Ed. 1.1 b:2024
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
IEC 80601-2-78:2019+AMD1:2024 CSV 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 PATIENTÂ’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).
SDO IEC: International Electrotechnical Commission
Document Number IEC 80601
Publication Date June 5, 2024
Language b - English & French
Page Count
Revision Level 1.1
Supercedes
Committee 62d
Publish Date Document Id Type View
June 5, 2024 Revision
June 5, 2024 IEC 80601-2-78 Ed. 1.1 b:2024 Revision
July 1, 2019 Revision
July 1, 2019 IEC 80601-2-78 Ed. 1.0 b:2019 Revision