D2.1 Requirements and Specification - CORBYS

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D2.1 Requirements and Specification and test protocols Reason / Comments: Indicative priority Mandatory 8.1.1.2 Interfaces Requirement No.: CTREF9 Name: Evaluation of sub-system conformance testing outcomes Description: For sub-system conformance testing, the outcomes will be determined as a result of conformance testing involving the partners delivering (technology development work packages) and receiving technology (system integrators) Reason / Comments: Indicative priority Mandatory Requirement No.: CTREF10 Name: Sub-system components not meeting all conformance testing requirements Description: It must be anticipated that not all sub-systems will meet all conformance test requirements. In these cases, there will have to be a discussion about the severity of the failed items, the possibility to correct these items at a later stage (during integration stages), and the overall system consequences of not integrating the component in question. Reason / Comments: Indicative priority Mandatory Requirement No.: CTREF11 Name: Evaluation of integrated system conformance testing outcomes Description: For integrated system conformance testing, the outcomes will be determined as a result of conformance testing involving WP 8 (system integrators) on one side and WP 9 (clinical evaluation) partners Reason / Comments: Indicative priority Mandatory 8.1.1.3 Roles and responsibilities Requirement No.: CTREF12 Name: Sub-system responsibility Description: The sub-system functionality and performance is the responsibility of the partner(s) developing the sub-system during all testing and integration stages. Reason / Comments: After the integration stage, the responsibility will have to be shared with all partners, but all partners have responsibility to offer and provide guidance, service and other assistance during the integration and evaluation stages Indicative priority Mandatory 8.1.1.4 Operating environment Requirement No.: CTREF13 Name: CORBYS gait system target operating environment Description: The CORBYS gait rehabilitation system will be designed to work in typical health institution environments. Reason / Comments: The CORBYS gait rehabilitation system will not be suitable for outdoor all-weather usage. Indicative priority Mandatory Requirement No.: CTREF14 Name: CORBYS gait system target operating mode (ambulatory/not ambulatory) 88
D2.1 Requirements and Specification Description: The CORBYS gait rehabilitation system will be designed to be ambulatory, e.g., with wheels, moving around during gait rehabilitation therapy. Reason / Comments: Indicative priority Mandatory 8.1.1.5 Resources Requirement No.: CTREF15 Name: Sub-system conformance testing equipment Description: Special, dedicated test equipment, jigs et cetera required to perform conformance testing are supplied by the developing partner of the sub-system Reason / Comments: Indicative priority Mandatory 8.1.2 Non Functional Requirements 8.1.2.1 Performance Requirement No.: CTREF16 Name: Sub-system conformance testing of performance Description: Performance testing is not the main concern of conformance testing, but should have been carried out by developers of the sub-system prior to integration. Some limited performance testing should however be included in the conformance testing to verify functionality (such as to verify that an increase in control system load gives the expected feedback) Reason / Comments: Indicative priority Mandatory 8.1.2.2 Safety and reliability Requirement No.: CTREF17 Name: Sub-system evaluation of user hasards and safety Description: User safety is a prime concern for all medical devices. During conformance testing and in integration stages, hasards and safety concerns of all sub-systems shall be evaluated as part of the sub-system hand-over to integration partners. Hasards and safety aspects shall be considered for all CORBYS users - both patients and professionals. Reason / Comments: Indicative priority Mandatory Requirement No.: CTREF18 Name: Sub-system evaluation of reliability Description: The developer of the sub-system is responsible for ensuring that their sub-system components operate reliably. The developer’s effort to ensure this should be discussed during conformance testing. Reason / Comments: Indicative priority Mandatory 89
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CORBYS Cognitive Control Framework
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D2.1 Requirements and Specification
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D2.1 Requirements and Specification - CORBYS

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