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.
Note: A MOVEMENT FUNCTION is a function consisting of one or more of sensory, neuromusculoskeletal or movement-related body functions that comprise PATIENT motor control.
A RACA ROBOT is defined in this standard as a PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS) with a LEVEL OF AUTONOMY greater than zero, comprising an ACTUATED APPLIED PART, intended by its MANUFACTURER to perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION
Note 1: a LEVEL OF AUTONOMY of zero is defined as having no AUTONOMY in any of its functions
RACA ROBOTS covered by this particular standard include but are not limited to:
• Exoskeletons or robotic orthoses for upper and lower limbs for ASSESSMENT, REHABILITATION, ALLEVIATION or COMPENSATION
• Robotic end-effectors for upper / lower extremities for ASSESSMENT or REHABILITATION
• Active balance control equipment for ASSESSMENT or REHABILITATION
• Overhead robotic body weight support systems
• Robotic walkers
• Robots intended to alleviate hemiplegic shoulder/ joint pain or spasticity through movement
• Continuous Passive Motion devices with a LEVEL OF AUTONOMY
Note 2: Annex AA lists examples of RACA ROBOT.
Note 3: This particular standard is primarily focused on human beings but, may also be used for animal PATIENTS.
The RISK MANAGEMENT PROCESS may be necessary to address specific BASIC SAFETY and ESSENTIAL PERFORMANCE for animal PATIENTS.
This particular standard does not apply to:
• Devices that support activities of daily living (including active assisted living), but do not directly address PATIENT MOVEMENT FUNCTIONS, such as:
o electric wheelchairs (use ISO 7176 (all parts)),
o personal care / service robots (use ISO 13482: 2014), e.g. feeding robots, robotic hoists, robotic bed
• Devices with a LEVEL OF AUTONOMY of zero
o E.g. Continuous Passive Motion devices with no AUTONOMY
• the following devices which are covered by other standards:
o external limb prosthetic devices (use ISO 22523: 2006),
o diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33: 2022),
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1 The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
o stationary training equipment (ISO 20957 series) e.g. treadmills
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.
Required fields are indicated with *
