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DSF/IEC/FDIS 82304-1 - HEALTH SOFTWARE -- PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Description: 1.1 Purpose This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS. 1.2 Field of application This document covers the entire lifecycle including design, development, VALIDATION, installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS. In each referenced standard, the term “medical device” or “medical device software” is to be substituted by the term “HEALTH SOFTWARE” or “HEALTH SOFTWARE PRODUCT”, as appropriate.
DS/IEC 82304-1 - HEALTH SOFTWARE – PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Date: 2016-11-10
Description: 1.1 Purpose This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS. 1.2 Field of application This document covers the entire lifecycle including design, development, VALIDATION, installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS. In each referenced standard, the term “medical device” or “medical device software” is to be substituted by the term “HEALTH SOFTWARE” or “HEALTH SOFTWARE PRODUCT”, as appropriate.
CENELEC - EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: CENELEC
Date: 2017-09-01
Description: Field of application This document covers the entire lifecycle including design, development, VALIDATION, installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS. In each referenced standard, the term “medical device” or “medical device software” is to be substituted by the term “HEALTH SOFTWARE” or “HEALTH SOFTWARE PRODUCT”, as appropriate.
ISO/IEC DIS 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: ISO
Date: 2015-07-31
Description: Specifically, IEC 82304-1 does not apply to: a) medical electrical equipment or systems covered by the IEC 60601/IEC 80601 series; b) in vitro diagnostic equipment covered by the IEC 61010 series; c) implantable devices covered by the ISO 14708 series NOTE This standard also applies to HEALTH SOFTWARE PRODUCTS (e.g., medical apps, health apps) intended to be used in combination with mobile computing platforms.
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.
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.
IEC 61223-3-1 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-1: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHIC AND RADIOSCOPIC SYSTEMS - EDITION 1.0 Organization: IEC
Date: 1999-03-01
Description: This standard applies to the performance of X-RAY EQUIPMENT in the ACCEPTANCE TEST on the following medical diagnostic X-RAY EQUIPMENT and ASSOCIATED EQUIPMENT: – radiography equipment, for example: • stationary radiography EQUIPMENT; • mobile radiography EQUIPMENT; • skull radiography EQUIPMENT; • lung radiography EQUIPMENT; • TOMOGRAPHY EQUIPMENT – excluding COMPUTED TOMOGRAPHY; • radiography devices (SPOTFILM DEVICES) in RADIOSCOPY EQUIPMENT; • angiography EQUIPMENT (excluding DSA function); • CINERADIOGRAPHY equipment; – RADIOSCOPY EQUIPMENT, including: • combined radiographic and radioscopic EQUIPMENT.
CTA-CEB18 - RECOMMENDED PRACTICE FOR TRANSMITTER CONTROL AND STATUS INDICATION IN TRANSMITTING PORTABLE ELECTRONIC DEVICES (T-PEDS) - FORMERLY CEA-CEB18 Organization: CTA
Date: 2007-01-01
Description: This Recommended Practice is intended for use by portable electronic device (PED) manufacturers, related component and software companies, the air transport industry, relevant government regulatory agencies, and other stakeholders that might require information on transmitting status of T-PEDs to facilitate policies.
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: It emphasizes the privacy and security of using such devices. The role of mobile sensing, wireless power and Markov decision process in distributed computing is also examined.
PACKT - GETTING STARTED WITH RESE - GETTING STARTED WITH RESEARCHKIT Organization: PACKT
Date: 2016-02-18
Description: Enter the era of medical research using mobile devices with the help of this guide on ResearchKit!
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 - BYOD FOR HEALTHCARE - BYOD FOR HEALTHCARE Organization: CRC
Date: 2014-04-23
Description: There is also a full set of appendices that include information on everything from security settings for Apple iOS devices to a sample employee mobile device agreement. I thank those who assisted me in putting this book together.

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