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EU - 93/42/EEC - COUNCIL DIRECTIVE CONCERNING MEDICAL DEVICES - AMENDED BY 98/79/EC:10/27/1998, 2000/70/EC:11/16/2000, 2001/104/EC:12/7/2001,(EC) NO 1882/2003:9/29/2003, 2007/47/EC:9/5/2007 Organization: EU
Date: 1993-06-14
Description: For the purposes of this Directive, the following definitions shall apply: (a) ►M5 ‘medical device' means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: ◄ — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy or of a physiological process, — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; (b) ‘accessory' means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
VDI 5703 - SYSTEMATICAL DEVELOPMENT FOR A MODEL-BASED TESTING OF MEDICAL DEVICES Organization: VDI
Date: 2015-09-01
Description: The scope of this VDI Standard is meant for the development of model-based tests (e.g. on the basis of physical, chemical, biological, or numeric models), which are applied in order to ensure warranty of safety and function, product design and development, certification, reimbursement by public health insurances or product monitoring of medical products, • for materials, components, or complete products, • by manufacturers and users of medical devices, research institutions, test institutes and other authorities.
DSF/FPREN 16602-20-10 - SPACE PRODUCT ASSURANCE - OFF-THE-SHELF ITEMS UTILIZATION IN SPACE SYSTEMS Organization: DS
Description: This Standard considers complex OTS items, as for example: motherboards, cards, data storage units/items, optical equipments, photo cameras and video units, LANs, mechanical/electrical and electromechanical devices, batteries, sensors, monitoring support units, medical equipments and items, laptops.
NBN - EN 16602-20-10 - SPACE PRODUCT ASSURANCE - OFF-THE-SHELF ITEMS UTILIZATION IN SPACE SYSTEMS Organization: NBN
Date: 2014-10-24
Description: This Standard considers complex OTS items, as for example: motherboards, cards, data storage units/items, optical equipments, photo cameras and video units, LANs, mechanical/electrical and electromechanical devices, batteries, sensors, monitoring support units, medical equipments and items, laptops.
NBN - EN 16602-20-10 - ASSURANCE PRODUIT DES PROJETS SPATIAUX - UTILISATION D'ÉLÉMENTS SUR ÉTAGÈRES DANS LES SYSTEMES SPATIAUX Organization: NBN
Date: 2014-10-24
Description: This Standard considers complex OTS items, as for example: motherboards, cards, data storage units/items, optical equipments, photo cameras and video units, LANs, mechanical/electrical and electromechanical devices, batteries, sensors, monitoring support units, medical equipments and items, laptops.
CEN - EN 16602-20-10 - SPACE PRODUCT ASSURANCE - OFF-THE-SHELF ITEMS UTILIZATION IN SPACE SYSTEMS Organization: CEN
Date: 2014-09-01
Description: This Standard considers complex OTS items, as for example: motherboards, cards, data storage units/items, optical equipments, photo cameras and video units, LANs, mechanical/electrical and electromechanical devices, batteries, sensors, monitoring support units, medical equipments and items, laptops.
DIN EN 16602-20-10 - SPACE PRODUCT ASSURANCE - OFF-THE-SHELF ITEMS UTILIZATION IN SPACE SYSTEMS; ENGLISH VERSION EN 16602-20-10:2014 Organization: DIN
Date: 2014-12-01
Description: This Standard considers complex OTS items, as for example: motherboards, cards, data storage units/items, optical equipments, photo cameras and video units, LANs, mechanical/electrical and electromechanical devices, batteries, sensors, monitoring support units, medical equipments and items, laptops.
CRC - TELEMEDICINE AND ELECTRON - TELEMEDICINE AND ELECTRONIC MEDICINE Organization: CRC
Date: 2015-11-24
Description: Preface Introduction purpose of the Telehealth and Mobile Health Handbook is to provide a reference that is both concise and useful for biomedical engineers in universities and medical device industries, scientists, designers, managers, research personnel, and students, as well as healthcare personnel, such as physicians, nurses, and technicians, who use technology over a distance.
CRC - TELEHEALTH AND MOBILE HEA - TELEHEALTH AND MOBILE HEALTH Organization: CRC
Date: 2015-12-02
Description: Preface Introduction The purpose of the Telehealth and Mobile Health handbook is to provide a reference that is both concise and useful for biomedical engineers in universities and medical device industries, scientists, designers, managers, research personnel, and students, as well as healthcare personnel, such as physicians, nurses, and technicians, who use technology over a distance.
CRC - IMAGE-GUIDED RADIATION - IMAGE-GUIDED RADIATION THERAPY Organization: CRC
Date: 2012-02-22
Description: Similarly important, computing and imaging science software algorithms and tools serve as the infrastructure to integrate the various IMRT processes into a procedure that can be readily implemented in the clinic.

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