4.5.1 In the first phase of the alternative and/or
equivalency process the Preliminary design is carried out by the Submitter.
A draft of the alternative and/or equivalent under consideration is
developed, taking into account among other things general arrangement,
components as well as the boundary conditions of the system, including
physical boundaries and system interfaces.
4.5.2 The objective of this phase is to develop
a common level of understanding of the proposed alternative and/or
equivalent design to enable the subsequent tasks of the submission
and approval process to be properly defined and carried out. Those
rules, standards and/or regulations that are being challenged should
be identified and thoroughly explained by the Submitter. Furthermore,
prior to the start of the project, a selection may be made of the
appropriate terminology and semantics. The definition of the terminology
and semantics used in the approval process avoids misinterpretation
and thus increases the efficiency of the process.
4.5.3 The Submitter submits the Preliminary design
description addressing the above-mentioned aspects to the Administration.