IEC 80601-2-78:2019
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Hardcopy , PDF
English - French
09-07-2019
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).
| Committee |
TC 62/SC 62D
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-7000-4
|
| Pages |
191
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Standards | Relationship |
| VDE 0750-2-78:2021-05 | Identical |
| NF EN IEC 80601-2-78:2020 | Identical |
| DIN EN IEC 80601-2-78:2021-05 | Identical |
| EN IEC 80601-2-78:2020 | Identical |
| NEN-EN-IEC 80601-2-78:2020 | Identical |
| ANSI/AAMI/IEC 80601-2-78:2020 | Identical |
| CEI EN IEC 80601-2-78:2020 | Identical |
| I.S. EN IEC 80601-2-78:2020 | Identical |
| BS EN IEC 80601-2-78:2020 | Identical |
| UNE-EN IEC 80601-2-78:2020 | Identical |
| BS EN 50363-0:2011 | Identical |
| JIS T 80601-2-78:2022 | Identical |
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