Search results
Results from the WOW.Com Content Network
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 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
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 ...
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
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 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 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 original GDF specification was introduced in 2005 as a new data format to overcome some of the limitations of the European Data Format for Biosignals (EDF). GDF was also designed to unify a number of file formats which had been designed for very specific applications (for example, in ECG research and EEG analysis). [ 2 ]