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DS/ISO TR 80002-2 - MEDICAL DEVICE SOFTWARE – PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS Organization: DS
Date: 2017-06-19
Description: It does not apply to – software used as a component, part or accessory of a medical device, or – software that is itself a medical device.
ISO TR 80002-2 - MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS - FIRST EDITION Organization: ISO
Date: 2017-06-01
Description: It does not apply to — software used as a component, part or accessory of a medical device, or — software that is itself a medical device.
AAMI TIR80002-2 - MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS Organization: AAMI
Date: 2017-01-01
Description: It does not apply to — software used as a component, part or accessory of a medical device, or — software that is itself a medical device.
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;
CRC - KE23211 - MOBILE POINT-OF-CARE MONITORS AND DIAGNOSTIC DEVICE DESIGN Organization: CRC
Date: 2014-09-12
Description: Efficient mobile systems that allow for vital sign monitoring and disease diagnosis at the point of care can help combat issues such as rising healthcare costs, treatment delays in remote and resource-poor areas, and the global shortage of skilled medical personnel. Covering everything from sensors, systems, and software to integration, usability, and regulatory challenges, Mobile Point-of-Care Monitors and Diagnostic Device Design offers valuable insight into state-of-the-art technologies, research, and methods for designing personal diagnostic and ambulatory healthcare devices.
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.
CRC - KE14478 - PIEZOELECTRIC MATERIALS AND DEVICES : APPLICATIONS IN ENGINEERING AND MEDICAL SCIENCES Organization: CRC
Date: 2016-04-19
Description: Elaborates on design and virtual prototyping of piezoelectric devices through the use of FE software tools ANSYS and PAFEC Giving design engineers, scientists, and technologists the information and guidance they will need to adopt piezoelectric materials in the development of smart devices, this book will also motivate engineering and science students to initiate new research for developing innovative devices.
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.
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.
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.
WILEY - WIRELESS COMPUTING IN MED - WIRELESS COMPUTING IN MEDICINE: FROM NANO TO CLOUD WITH ETHICAL AND LEGAL IMPLICATIONS Organization: WILEY
Date: 2016-07-01
Description: Defines the technologies of distributed wireless health, from software that runs cloud computing data centers, to the technologies that allow new sensors to work Explains the applications of nanotechnologies to prevent, diagnose and cure disease Includes case studies on how the technologies covered in the book are being implemented in the medical field, through both the creation of new medical applications and their integration into current systems Discusses pervasive computing's organizational benefits to hospitals and health care organizations, and their ethical and legal challenges Author: Mary Mehrnoosh Eshaghian-Wilner
CRC - KE23567 - TECHNOLOGIES FOR SMART SENSORS AND SENSOR FUSION Organization: CRC
Date: 2014-04-14
Description: Featuring contributions from authors working at the leading edge of sensor technology, Technologies for Smart Sensors and Sensor Fusion showcases the latest advancements in sensors with biotechnology, medical science, chemical detection, environmental monitoring, automotive, and industrial applications.
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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