$77
CEI EN IEC 80601-2-78
2020
Medical Electrical Equipment Part 2: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
- Format:
- Language(s) :
- Published :
- English
- 09/01/2020
This part of IEC 80601 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.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
NOTE See also 4.2 of the general standard.
This particular standard 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).
| CEI EN IEC 80601-2-78 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | CEI EN IEC 80601-2-78 |
| Scope | Medical Electrical Equipment Part 2: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| Publisher | CEI - Comitato Elettrotecnico Italiano |
| Languages | English |
| State | [ Active ] |
| Publication Year | 2020 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| Edition | 20 |
| File Size | 1 file , 3.3 MB |
| Number of Pages | 84 |
| Published | 09/01/2020 |
| CEI EN IEC 80601-2-78 | ||
|---|---|---|
| History | Publisher Year | |
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