CEI EN IEC 80601-2-78:2020
Current
The latest, up-to-date edition.
Medical Electrical Equipment Part 2: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Hardcopy , PDF
English
01-09-2020
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.
| Committee |
CT 62
|
| DevelopmentNote |
New child AMD 1 2025 is added
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-7000-4
|
| Pages |
110
|
| ProductNote |
New child AMD 1 2025 is added
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Standards | Relationship |
| IEC 80601-2-78:2019 | Identical |
| EN IEC 80601-2-78:2020 | Identical |
| IEC GUIDE 109:2012 | Environmental aspects - Inclusion in electrotechnical product standards |
| ISO 10218-1:2011 | Robots and robotic devices — Safety requirements for industrial robots — Part 1: Robots |
| ISO 8373:2012 | Robots and robotic devices — Vocabulary |
| IEC 60601-2-33:2010 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| IEC 61924-2:2012 | Maritime navigation and radiocommunication equipment and systems - Integrated navigation systems - Part 2: Modular structure for INS - Operational and performance requirements, methods of testing and required test results |
| IEC 60601-1-9:2007 | Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO 13482:2014 | Robots and robotic devices — Safety requirements for personal care robots |
| ISO 7176-19:2008 | Wheelchairs — Part 19: Wheeled mobility devices for use as seats in motor vehicles |
| IEC TR 62366-2:2016 | Medical devices - Part 2: Guidance on the application of usability engineering to medical devices |
| ISO 9999:2016 | Assistive products for persons with disability — Classification and terminology |
| IEC TR 60601-4-1:2017 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| ISO 11064-7:2006 | Ergonomic design of control centres — Part 7: Principles for the evaluation of control centres |
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