Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies1 Scope This document provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies. It is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical

• The handbook ECSS-E-HB-50

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BS EN 4020:2009  Aerospace series

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NOTE Though the terms in this standard are horizontally applicable to bio-based products