1993 – EN 540

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The standard EN 540 is being published and describes the performance of clinical trials.

Standard

A technical standard is an established norm in regard to technical or scientific systems. It usually establishes uniform engineering or technical criteria, methods, processes and practices. In contrast a custom, convention or company product that becomes generally accepted is often called a de facto standard.

A technical standard may be developed by a corporation, regulatory body, trade union or another standard organization.
Standards can also be developed by social or political groups such as voluntary standards or through legislation.

Clinical trial

Clinical trials are experiments or observations done in clinical research on patients or healthy volunteers. They aim to answer specific questions about biomedical interventions and new treatments in terms of the efficacy and safety of drugs and medical devices. Clinical trials are necessary condition for the official registration of novel drugs. Essentially they are designed as intervention studies or observational studies.

 

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