SCHEDULE 3TECHNICAL DOCUMENTATION

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 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 the requirements of these Regulations under declared rated operating conditions and under specified environmental disturbances and with 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.