Detailed requirements will be defined for the alternative
and/or equivalency design by the Administration and the Submitter
jointly on the basis of the results of the quantitative risk analyses
in order to achieve approval. These requirements address the following
topics:
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.1 approval tests: testing and analysis methods
required to confirm assumptions used for the quantitative risk analysis;
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.2 approval numerical calculations/simulations:
numerical results required to demonstrate quantitative performance;
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.3 manufacturing: level of quality control during
manufacturing and installation; and
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.4 operation: operational limits and maintenance,
including definition of operation and maintenance procedures, as well
as data acquisition and assessment during operation.