D2.1 Requirements and Specification - CORBYS
D2.1 Requirements and Specification - CORBYS
D2.1 Requirements and Specification - CORBYS
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<strong>D2.1</strong> <strong>Requirements</strong> <strong>and</strong> <strong>Specification</strong><br />
8.2.2.2 Safety <strong>and</strong> reliability<br />
Requirement No.: SIREF13<br />
Name: System evaluation of user hazards <strong>and</strong> safety<br />
Description: User safety is a prime concern for all medical devices. During integration stages, hasards <strong>and</strong><br />
safety concerns of all sub-systems shall be evaluated on a continuous basis, as well as in<br />
dedicated risks hasard meetings. The purpose of these meetings is to identify potential risks<br />
<strong>and</strong> find strategies to mitigate them. Risks <strong>and</strong> hazards evaluation shall consider all <strong>CORBYS</strong><br />
users – both patients <strong>and</strong> professionals<br />
Reason<br />
Comments:<br />
/<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: SIREF14<br />
Name: System integration reliability assessment<br />
Description: The integrated system will not be subject of extensive reliability tests (such as accelerated<br />
wear tests, climate chamber testing, <strong>and</strong> repeatability testing of sensor/actuators). The system<br />
will however not be released until a situation deemed as stable with a low frequency of<br />
failures have been reached.<br />
Reason / An acceptable failure rate has to be decided, but as a minimum, failures should not be<br />
Comments: expected during the time span of a typical rehabilitation session.<br />
Indicative priority M<strong>and</strong>atory<br />
8.2.2.3 Other<br />
Requirement No.: SIREF15<br />
Name: Integrated system must be possible to transport in Europe<br />
Description: The integrated system will have to be moved between various locations in Europe. The<br />
assembly quality of all components must therefore be sufficient to allow safe transport using<br />
commercial freight services<br />
Reason / The integrated system will have to be moved for display at one or more conferences, as well<br />
Comments: as when it will be deployed in the evaluation effort in clinical environments<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: SIREF16<br />
Name: The integrated system must be properly insured <strong>and</strong> declared at customs when transported<br />
across borders<br />
Description: With substantial accumulated effort <strong>and</strong> component value follows the need for insurance.<br />
With the component value follows also the need to avoid taxes at each customs border.<br />
Reason<br />
Comments:<br />
/<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: SIREF17<br />
Name: Number of gait rehabilitation devices to be developed<br />
Description: There will only be developed at least one complete one integrated system<br />
Reason<br />
Comments:<br />
/<br />
Indicative priority M<strong>and</strong>atory<br />
8.2.3 Assumptions <strong>and</strong> Dependencies<br />
Internal<br />
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