IEC 80601-2-78-2019 医疗电气设备--第2-78部分:康复、评估、补偿或减轻用医疗机器人的基本安全和基本性能的特殊要求 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
- 标准类别:
- 标准大小:
- 标准编号:IEC 80601-2-78-2019
- 标准状态:现行
- 更新时间:2023-10-17
- 下载次数:次
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).dition 1.0 2019-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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Medical electrical equipment -
Part 2-78: Particular requirements for basic safety and essential performance of
medical robots for rehabilitation, assessment, compensation or alleviation
Appareils alectromadicaux -
Partie 2-78: Exigences particuliares pour la sacurita de base et les performances
essentielles des robots medicaux dedies a la reeducation, I'evaluation, la
compensation ou I'attanuation
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