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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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
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 Measuring Instruments Directive 2014/32/EU, formerly 2004/22/EC, is a directive by the European Union, which seeks to harmonise many aspects of legal metrology across all member states of the EU. [1] Its most prominent tenet is that all kinds of meters which receive a MID approval may be used in all countries across the EU.
A standard practice or procedure gives a set of instructions for performing operations or functions. For example, there are detailed standard operating procedures for operation of a nuclear power plant. [3] A standard guide is general information or options that do not require a specific course of action.
during the 10 minute period of measurement 3 contractions occurred; subtract the resting tone from the peak intensity of the contraction; add the 3 contractions together to get the MVUs; Montevideo units are calculated by obtaining the peak uterine pressure amplitude and subtracting the resting tone.
User's guide for a Dulcitone keyboard. A user guide, also commonly known as a user manual, is intended to assist users in using a particular product, service or application. It is usually written by a technician, product developer, or a company's customer service staff. Most user guides contain both a written guide and associated images.
Certified reference materials (CRMs) are 'controls' or standards used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments. [1] A certified reference material is a particular form of measurement standard.
The operations manual is the documentation by which an organisation provides guidance for members and employees to perform their functions correctly and reasonably efficiently. [1] It documents the approved standard procedures for performing operations safely to produce goods and provide services. [ 2 ]