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The European respirator standards refer to the filtering classification by EN 149, EN 14683, and EN 143, all European standards of testing and marking requirements for respirators. [1] FFP standard masks (where FFP stands for filtering facepiece) [ 2 ] cover the nose, mouth and chin and may have inhalation and/or exhalation valves.
A Comparison of International Guidelines on Goal Blood Pressure and Initial Therapy for Adults With Hypertension (adapted from JNC 8 guidelines [1]) ; Guideline
European standards are generally annotated by the organization, standard number and year of publication (e.g. CEN 1789:2000 or CEN 1789/2007). Within member countries, [ 2 ] the annotation is likely to be adapted to include the local standards body, so that in Britain, the 'C' is dropped from the prefix, and replaced with ' BS ', in Germany ...
A style guide, or style manual, is a set of standards for the writing and design of documents, either for general use or for a specific publication, organization or field. The implementation of a style guide provides uniformity in style and formatting within a document and across multiple documents.
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 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 ...
The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance).The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.
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 ...