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 PATIENTS 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).
Status: PublishedPublication date: 2019-07
Edition: 1Number of pages: 144
Technical Committee: ISO/TC 299 Robotics
- ICS :
- 11.040.01 Medical equipment in general
This standard contributes to the following Sustainable Development Goals:
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|std 1 330||Paper|
|std 2 330|
IEC 80601-2-78:2019Stage: 60.60
Corrigenda / AmendmentsUnder development
IEC 80601-2-78:2019/DAmd 1
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