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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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
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 45502-1: Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer; EN 45545: Railway applications. Fire protection on railway vehicles. EN 45545-1: Railway applications. Fire protection on railway vehicles. General; EN 45545-2: Railway applications. Fire ...
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
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.
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
CEN 1789:2020 is the European Union standard for ambulances and medical transportation vehicles. This European standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients.