SCHEDULE 3TECHNICAL DOCUMENTATION
1
The technical documentation shall render the design, manufacture and operation of the relevant instrument intelligible and shall permit an assessment of its conformity with the appropriate requirements of these Regulations.
2
The technical documentation shall be sufficiently detailed to ensure—
a
the definition of the metrological characteristics;
b
the reproducibility of the metrological performances of produced relevant instruments when properly adjusted using appropriate intended means; and
c
the integrity of the instrument.
3
The technical documentation shall include insofar as relevant for assessment and identification of the type and/or instrument—
a
a general description of the instrument;
b
conceptual design and manufacturing drawings and plans of components, sub-assemblies and circuits;
c
manufacturing procedures to ensure consistent production;
d
if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operation;
e
descriptions and explanations necessary for the understanding of sub-paragraphs (b), (c) and (d), including the operation of the instrument;
f
a list of the relevant national standards and/or relevant normative documents, applied in full or in part;
g
descriptions of the solutions adopted to meet the essential requirements where the relevant national standards and/or relevant normative documents have not been applied;
h
results of design calculations and examinations;
i
the appropriate test results, where necessary, to demonstrate that the type and/or instrument is compliant with—
i
the requirements of these Regulations under declared rated operating conditions and under specified environmental disturbances; and
ii
the durability specifications; and
j
the EC-type examination certificates or EC design examination certificates in respect of instruments containing parts identical to those in the design.
4
The manufacturer shall specify where seals and markings have been applied.
5
The manufacturer shall indicate the conditions for compatibility with interfaces and sub-assemblies, where relevant.