BS EN IEC 80601-2-78:2020
Current
The latest, up-to-date edition.
Medical electrical equipment Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Hardcopy , PDF
English
06-04-2020
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/62/4
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| DocumentType |
Standard
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| ISBN |
9780580965791
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| Pages |
82
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| ProductNote |
This standard also refers to EN 62366-1:2015/AC:2015, EN 60601-1-10:2008, EN 60601-1-6:2010,
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| PublisherName |
British Standards Institution
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| Status |
Current
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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).
| Standards | Relationship |
| EN 50363-0:2011 | Identical |
| IEC 80601-2-78:2019 | Identical |
| EN IEC 80601-2-78:2020 | Identical |
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