4.6.1 In this phase, the Submitter organizes a
Preliminary design preview meeting with the Administration in order
to discuss the concept, relevant rules/guides/codes/standards as well
as the further phases involved in the approval process.
4.6.2 The purpose of this meeting is to identify
and describe items requiring special attention and to plan how these
items are handled by the Administration and Submitter with respect
to approval.
4.6.3 The aim of the Preliminary preview phase
is also to decide whether the alternative and/or equivalency challenge
any prescriptive rules, regulations or standards to such an extent
that a risk analysis is required. The safety and environmental aspects
of the alternative and/or equivalency design are crucial for this
decision. If the Administration comes to the conclusion that there
is no need of a risk analysis, the Submitter can follow a conventional
approval process, to be determined by the Administration.
4.6.4 The decision whether the alternative and/or
equivalency requires a risk-based analysis demonstrating that an equivalent
level of safety may be reached by using table 1 to determine the degree
of novelty. This decision needs to be transparently documented by
the Administration (for the purpose of objectivity). Technology in
category 1 is proven technology where proven methods for classification,
tests, calculations and analyses may be used. Technology in categories
2-4 is defined as new technology and may follow the procedure described
in this report. The distinction between categories 2, 3 and 4 makes
it easier to focus on the areas of concern. The objective of using
the categorization is to establish whether or not the alternative
and/or equivalency design qualifies as a novel design and to gain
a general understanding of the variation from proven designs. The
categorization will also assist in defining the level of detail of
the different analyses that will be required in the following phase.
|
Table 1: Categorization of new technology
|
|
|
Technology status
|
| Proven
|
Limited field history
|
New or unproven
|
|
Application Area
|
1
|
2
|
3
|
| Known
|
0
|
1
|
2
|
3
|
| New
|
1
|
2
|
3
|
4
|
4.6.5 The Preliminary design preview meeting should
include relevant people from the Submitter and professionals from
the different disciplines including risk assessment within or contracted
by the Administration.
4.6.6 Ideally, the representatives of the Administration
who take part in the initial Preliminary design preview meetings should
also take part in the definition of the approval basis, monitor the
subsequent analyses and follow the project until final approval in
order to take advantage of the learning process that occurs throughout
entire approval process.
4.6.7 During the Preliminary design preview phase,
the Submitter may be required to submit the following documents:
-
.1 general description of alternative and/or equivalency;
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.2 functional description of alternative and/or
equivalency;
-
.3 identification of interfaces between alternative
and/or equivalency and other systems/operations;
-
.4 preliminary general arrangement drawings;
-
.5 preliminary detail drawings, if required;
-
.6 list of codes and standards applied;
-
.7 risk assessment plans; and
-
.8 further design basis documents, if necessary.