Biomedical Engineering Reference
In-Depth Information
EAL4: Methodically Designed, Tested, and Reviewed. It applies when develop-
ers or users require moderate to high independently assured security in conven-
tional commodity products and are prepared to incur additional security-specific
engineering costs.
EAL5: Semi-formally Designed and Tested. It applies when developers or users
require high, independently assured security in a planned development and re-
quire a rigorous development approach that does not incur unreasonable costs
from specialist security engineering techniques.
EAL6: Semi-formally Verified Design and Tested. It applies when developing
security targets of evaluation for application in high-risk situations where the
value of the protected assets justifies the additional costs.
EAL7: Formally Verified Design and Tested. It applies to the development of se-
curity targets of evaluation for application in extremely high-risk situations, as
well as when the high value of the assets justifies the higher costs.
References
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tion and general model. http://www.iec.ch/ .
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functional requirements. http://www.iec.ch/ .
4. CC (2009). Common criteria for information technology security evaluation, part 3: Security
assurance components. http://www.iec.ch/ .
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Health, US FDA.
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311). Berlin: Springer.
11. IEC62304 (2006). International Electrotechnical Commission: Medical device software—
software life-cycle processes. http://www.iec.ch/ .
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of electrical/electronic/programmable electronic safety-related systems. http://www.iec.ch/ .
13. IEEE-SA. IEEE Standards Association. http://standards.ieee.org/ .
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15. IEEE Std. 730-1998. IEEE standard for software quality assurance plans. http://standards.
ieee.org/ .
16. IEEE
Std.
1012-1998.
IEEE
standard
for
software
verification
and
validation.
http://
standards.ieee.org/ .
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