6.1 The objective of the System Design Limitations approach is twofold. First, it ensures
that the performance of the BWMS has been transparently assessed with respect to the
known water quality and operational parameters that are important to its operation,
including those that may not be specifically provided for in these Guidelines. Second,
it provides transparent oversight of manufacturer BWMS performance claims that may go
beyond specific criteria in these Guidelines. Although the validation of System Design
Limitations yields transparent information that is reported on the Type Approval
Certificate, this information does not affect the eligibility of a BWMS to receive type
approval.
6.2 The low and/or high parameter values for each system design limitation should be
validated to the satisfaction of the Administration as follows:
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.1 the validation should be overseen by the Administration and should consist
of a rigorous evidence-based assessment of a specific claim by the BWMS
manufacturer that the equipment will operate as intended between pre-stated
parameter values;
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.2 tests to validate System Design Limitations should be undertaken in
accordance with section 2.1 of this annex. Such tests may be combined with
land-based and/or shipboard testing if the QAPP establishes that the
validation tests will not interfere with the specific procedures in Part 2
of this annex. Laboratory or bench-scale testing may also be used in the
validation of System Design Limitations;
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.3 methods other than testing, such as the use of existing data and/or
models, may be used in the validation of System Design Limitations. The
source, suitability and reliability of such methods should be reported; and
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.4 validation is not intended as a stress-test of the BWMS or as a procedure
for identifying equipment failure points. Validation should be undertaken
independently of the BWMS manufacturer and should be separate from BWMS
research and development activities. Data and models may be supplied by
manufacturer when appropriate but should be independently assessed.
6.3 Claims of open-ended performance (expressed as the lack of either a low or a high
parameter value for a system design limitation) should also be validated.
6.4 BWMS manufacturers may include a margin of error in claiming System Design
Limitations. For this reason, System Design Limitations should not necessarily be
interpreted as the exact parameter values beyond which the BWMS is incapable of
operation. The Administration should take this into account in considering whether to
include any additional restrictions on the Type Approval Certificate in connection with
the validation of System Design Limitations.
6.5 System Design Limitations should be established for all known parameters to which the
design of the BWMS is sensitive that are important to the operation of the BWMS. In the
case of system design limitation parameters that are also subject to specific criteria
in Part 2 of this annex, the procedure set out in Part 2 should be followed. For such
parameters, the approach in paragraph 6.2 may be used only to the extent that the
performance claim goes beyond the specific criteria in Part 2.
6.6 A report should be submitted to the Administration containing all documentation
(including procedures, methods, data, models, results, explanations and remarks)
associated with the validation of System Design Limitations. The report should include
at least the information identified in paragraph 2.7.2 of this annex.