ISO IEC 80601-2-78:2019

Current Revision

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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ISO IEC 80601-2-78:2019

Name: ISO IEC 80601-2-78:2019 – Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Brand: International Organization for Standardization
SKU: ISO IEC 80601-2-78:2019
Price: 473.55 USD
Availability: InStock

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 2019

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).