D2.1 Requirements and Specification - CORBYS

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D2.1 Requirements and Specification documentation of plans, timelines and issues stored on the CORBYS file sharing system (WebDAV) Reason / Comments: Indicative priority Mandatory 8.2.1.3 Roles and responsibilities Requirement No.: SIREF11 (confer 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 8.2.1.4 Operating environment Operation environment requirements correspond 1:1 to the requirements for conformance testing: CTREF13 and CTREF14 Requirement No.: SIREF12 (confer CTREF13) Name: Integrated system power resources Description: The Consortium need to decide whether a battery or a mains powered system will be targeted Reason / Comments: Indicative priority Mandatory 8.2.1.5 Resources Requirement No.: SIREF13 Name: Resource limitations encountered in the system integration stage Description: Resource limitations emerging in the integration stage (for example power or processing will have to be dealt with in a process involving the system integrators and the partners sharing the limited resource) Reason / Comments: Indicative priority Mandatory 8.2.2 Non Functional Requirements 8.2.2.1 Performance Requirement No.: SIREF12 (confer CTREF12) Name: Integrated system performance testing Description: The integrated system will be subject to performance testing. These tests will partly be to done to verify that sub-components performs as planned, and partly to verify that system features of the integrated system performs. Performance test parameters will be derived/extracted from target system specifications Reason / Comments: Indicative priority Mandatory 92
D2.1 Requirements and Specification 8.2.2.2 Safety and reliability Requirement No.: SIREF13 Name: System evaluation of user hazards and safety Description: User safety is a prime concern for all medical devices. During integration stages, hasards and safety concerns of all sub-systems shall be evaluated on a continuous basis, as well as in dedicated risks hasard meetings. The purpose of these meetings is to identify potential risks and find strategies to mitigate them. Risks and hazards evaluation shall consider all CORBYS users – both patients and professionals Reason Comments: / Indicative priority Mandatory Requirement No.: SIREF14 Name: System integration reliability assessment Description: The integrated system will not be subject of extensive reliability tests (such as accelerated wear tests, climate chamber testing, and repeatability testing of sensor/actuators). The system will however not be released until a situation deemed as stable with a low frequency of failures have been reached. Reason / An acceptable failure rate has to be decided, but as a minimum, failures should not be Comments: expected during the time span of a typical rehabilitation session. Indicative priority Mandatory 8.2.2.3 Other Requirement No.: SIREF15 Name: Integrated system must be possible to transport in Europe Description: The integrated system will have to be moved between various locations in Europe. The assembly quality of all components must therefore be sufficient to allow safe transport using commercial freight services Reason / The integrated system will have to be moved for display at one or more conferences, as well Comments: as when it will be deployed in the evaluation effort in clinical environments Indicative priority Mandatory Requirement No.: SIREF16 Name: The integrated system must be properly insured and declared at customs when transported across borders Description: With substantial accumulated effort and component value follows the need for insurance. With the component value follows also the need to avoid taxes at each customs border. Reason Comments: / Indicative priority Mandatory Requirement No.: SIREF17 Name: Number of gait rehabilitation devices to be developed Description: There will only be developed at least one complete one integrated system Reason Comments: / Indicative priority Mandatory 8.2.3 Assumptions and Dependencies Internal 93
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D2.1 Requirements and Specification - CORBYS

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