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European Data Format (EDF) is a standard file format designed for exchange and storage of medical time series.Being an open and non-proprietary format, EDF(+) is commonly used to archive, exchange and analyse data from commercial devices in a format that is independent of the acquisition system.
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
EN 62353:2014 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment; Moreover, there are a lot of ISO and IEC standards that were accepted as "European Standard" (headlined as EN ISO xxxxx) and are valid in the European Economic Region.
The SBL Handbook of Style includes a recommended standard format for abbreviation of Primary Sources in Ancient Near Eastern, biblical, and early Christian Studies. The Style Manual for Political Science—used by many American political science journals; published by the American Political Science Association.
The quality standards of the European Pharmacopoeia apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-nine (39) signatory states, which include all European Union member states. Several legal texts make the European Pharmacopoeia mandatory in Europe. [1]
The European Pharmacopoeia: setting quality standards for Europe and beyond and supplying pharmaceutical reference standards [ edit ] Published and regularly updated by the EDQM/ Council of Europe in English and French, the two official languages of the Council of Europe, the Ph. Eur. is a compendium of official quality standards for medicines ...
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis