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Software Safety Classification
Software installed in medical devices is assessed for health and safety Occupational safety and health (OSH), also commonly referred to as occupational health and safety (OHS), occupational health, or occupational safety, is a multidisciplinary field concerned with the safety, health, and welfare of people at ... issues according to international standards. Safety classes Software classification is based on the potential for hazard(s) that could cause injury to the user or patient. Per IEC 62304:2006+ A1:2015], the software can be divided into three separate classes: * The SOFTWARE SYSTEM is software safety class A if: **the SOFTWARE SYSTEM cannot contribute to a HAZARDOUS SITUATION; or **the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which does not result in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM. *The SOFTWARE SYSTEM is software safety class B if: **the SOFTWARE SYSTEM can contribute to a HAZARDOU ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software
Software is a set of computer programs and associated software documentation, documentation and data (computing), data. This is in contrast to Computer hardware, hardware, from which the system is built and which actually performs the work. At the low level language, lowest programming level, executable code consists of Machine code, machine language instructions supported by an individual Microprocessor, processor—typically a central processing unit (CPU) or a graphics processing unit (GPU). Machine language consists of groups of Binary number, binary values signifying Instruction set architecture, processor instructions that change the state of the computer from its preceding state. For example, an instruction may change the value stored in a particular storage location in the computer—an effect that is not directly observable to the user. An instruction System call, may also invoke one of many Input/output, input or output operations, for example displaying some text on ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health And Safety
Occupational safety and health (OSH), also commonly referred to as occupational health and safety (OHS), occupational health, or occupational safety, is a multidisciplinary field concerned with the safety, health, and welfare of people at work (i.e. in an occupation). These terms also refer to the goals of this field, so their use in the sense of this article was originally an abbreviation of ''occupational safety and health program/department'' etc. The goal of an occupational safety and health program is to foster a safe and healthy occupational environment. OSH also protects all the general public who may be affected by the occupational environment.Fanning, Fred E. (2003). Basic Safety Administration: A Handbook for the New Safety Specialist, Chicago: American Society of Safety Engineers Globally, more than 2.78 million people die annually as a result of workplace-related accidents or diseases, corresponding to one death every fifteen seconds. There are an additional 3 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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