ANSI/AAMI/ IEC 80601-2- 78:2020 pdf download – Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation.
201 .5.9.1 Applied parts Additional subclause: 201 .5.9.1 .1 01 Actuated APPLIED PARTS A CTUATED APPLIED PARTS are identified by inspection and referenced in the ACCOMPANYING DOCUMENTS . 201 .5.9.2.1 Test finger Addition: The tests as described in the general standard are additionally performed with the small finger probe shown in Figure 1 of IEC 60601-1-11:2015 for RACA ROBOT s, where applicable. 201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies. 201.7 M E EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows: 201 .7.2.4 A CCESSORIES Replacement: If misidentification of ACCESSORIES results in an unacceptable RISK , the MANUFACTURER shall follow 6.2 of ISO 14971:2007 and the stated priorities for RISK CONTROL . A CCESSORIES shall be marked as has been identified in the RISK MANAGEMENT PROCESS , but at least with  the name or trademark of their manufacturer,  a model or type reference,  a serial number or lot or batch identifier, if applicable, and  the date of manufacture or use-by date, if applicable. NOTE 1 See ISO 15223-1 for symbols for MANUFACTURER , serial number, lot or batch, year of manufacture and use by date. NOTE 2 The serial number, lot or batch identifier, and the date of manufacture can be provided in a human readable code or through automatic identification technology, such as barcodes or radio-frequency identification. Where no marking of the ACCESSORIES is practicable, these markings may be affixed to the individual packaging. 201 .7.9.2.5 ME EQUIPMENT description Addition to the list of the first paragraph:  a sufficient description of functions that have a degree of autonomy (including start-up PROCEDURE , restart PROCEDURE , shutdown PROCEDURE and maintenance), as needed for OPERATORS to develop adequate SITUATION AWARENESS .
201 .9.2.2.1 General Addition: For those RACA ROBOT s that contact objects in their environment, in order to fulfil their INTENDED USE , the space between the RACA ROBOT and its environment may not be feasible to be considered a TRAPPING ZONE . This situation shall be assessed in the RISK MANAGEMENT PROCESS . 201 .9.2.3 Other MECHANICAL HAZARDS associated with moving parts 201 .9.2.3.1 * Unintended movement Replacement and additional subclauses: 201 .9.2.3.1 .1 01 Unintended movement related to controls Controls shall be positioned, recessed, or protected by other means so that they cannot be accidentally actuated, unless the USABILITY ENGINEERING PROCESS concludes otherwise for the intended PATIENT (e.g. PATIENT with special needs) or activation does not result in an unacceptable RISK . NOTE Controls are understood as USER INTERFACES on the control devices actuated by the OPERATOR , such as switches, joysticks, touch panels (including smart devices), dials, or knobs. Compliance is checked by inspection of ME EQUIPMENT , and, if the control is part of the PRIMARY OPERATING FUNCTIONS , by inspection of the USABILITY ENGINEERING FILE . 201 .9.2.3.1 .1 02 * Unintended movement related to shared control between the PATIENT , OPERATOR or RACA ROBOT The MANUFACTURER shall identify unintended or unexpected movement or force/torque related to shared control between the PATIENT , OPERATOR or RACA ROBOT and address them in the RISK MANAGEMENT PROCESS . In case of unacceptable RISK , additional RISK CONTROL shall be implemented. If the movement of the RACA ROBOT is controlled according to physiological signals (e.g. EMG, ECG, or EEG signals) related to MOVEMENT FUNCTIONS of the PATIENT , this shall be considered in the RISK MANAGEMENT PROCESS .
201 .9.2.3.1 .1 03 Unintended movement related to unexpected release of energy The MANUFACTURER shall address unintended movement related to unexpected release of energy in the RISK MANAGEMENT PROCESS ; in case of unacceptable RISK , additional RISK CONTROL shall be implemented. NOTE Examples of energy sources are loaded springs, pressurized vessels (hydraulic or pneumatic), counterweights, flywheels. Stored electrical energy, when discharged, can through an actuator lead to unintended movement.