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The Measuring Instruments Regulations 2016 CHAPTER 2 — REQUIREMENTS AS TO THE TECHNICAL DOCUMENTATION REQUIRED FOR THE PURPOSES OF CONFORMITY ASSESSMENT

43–453 provisions

Application of this Chapter

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The technical documentation required for the purposes of conformity assessment under these Regulations must satisfy the requirements of this Chapter.

General requirements to be met by technical documentation

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(1) The technical documentation must— (a) render the design, manufacture and operation of the regulated measuring instrument intelligible; and (b) permit an assessment of its conformity with the applicable requirements of these Regulations . (2) The technical documentation must be sufficiently detailed to ensure compliance with the following requirements— (a) the definition of the metrological characteristics; (b) the reproducibility of the metrological performances of produced regulated measuring instruments when properly adjusted using appropriate intended means; and (c) the integrity of the regulated measuring instrument.

Specific information to be included in technical documentation

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(1) The technical documentation must, insofar as relevant for assessment and identification of either the regulated measuring instrument or its type (or both), include the following information— (a) a general description of the regulated measuring instrument; (b) the conceptual design and manufacturing drawings and plans of components, sub-assemblies, circuits etc.; (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 the information referred to in sub-paragraphs (b) to (d); (f) a list of any designated standards and normative documents which have been applied in full or in part ...; (g) descriptions of the solutions adopted to meet the essential requirements where designated standards or normative documents have not been applied, including a list of other relevant technical specifications applied; (h) results of design calculations, examinations etc.; (i) the appropriate test results, where necessary to demonstrate that the type or regulated measuring instruments or both comply with the following— (i) the requirements of these Regulations under declared rated operating conditions and under specified environmental disturbances; and (ii) the durability specifications for gas and water meters as well as for liquids other than water; and (j) the type examination certificates or ... design examinations certificates in respect of regulated measuring instruments containing parts identical to those in the design. (2) The manufacturer must specify where seals and markings have been applied. (3) The manufacturer must indicate the conditions for compatibility with interfaces and sub-assemblies where relevant.

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