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Software is a collection of instructions that tell a computer how to work. This is in contrast to hardware, from which the system is built and actually performs the work.
Interoperability is a characteristic of a product or system to work with other products or systems. While the term was initially defined for information technology or systems engineering services to allow for information exchange, a broader definition takes into account social, political, and organizational factors that impact system-to-system performance.
A safety-critical system (SCS) or life-critical system is a system whose failure or malfunction may result in one of the following outcomes:
The Therac-25 was a computer-controlled radiation therapy machine produced by Atomic Energy of Canada Limited (AECL) in 1982 after the Therac-6 and Therac-20 units.
Medical software is any software item or system used within a medical context, such as:
Computer-aided production engineering (CAPE) is a relatively new and significant branch of engineering. Global manufacturing has changed the environment in which goods are produced. Meanwhile, the rapid development of electronics and communication technologies has required design and manufacturing to keep pace.
Commercial off-the-shelf or commercially available off-the-shelf (COTS) products are packaged or canned (ready-made) hardware or software, which are adapted aftermarket to the needs of the purchasing organization, rather than the commissioning of custom-made, or bespoke, solutions. A related term, Mil-COTS, refers to COTS products for use by the U.S. military.
DO-178B, Software Considerations in Airborne Systems and Equipment Certification is a guideline dealing with the safety of safety-critical software used in certain airborne systems. It was jointly developed by the safety-critical working group RTCA SC-167 of the Radio Technical Commission for Aeronautics (RTCA) and WG-12 of the European Organisation for Civil Aviation Equipment (EUROCAE). RTCA published the document as RTCA/DO-178B, while EUROCAE published the document as ED-12B. Although technically a guideline, it was a de facto standard for developing avionics software systems until it was replaced in 2012 by DO-178C.
IEC 61508 is an international standard published by the International Electrotechnical Commission consisting of methods on how to apply, design, deploy and maintain automatic protection systems called safety-related systems. It is titled Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems.
A computer appliance is a computer with software or firmware that is specifically designed to provide a specific computing resource. Such devices became known as appliances because of the similarity in role or management to a home appliance, which are generally closed and sealed, and are not serviceable by the user or owner. The hardware and software are delivered as an integrated product and may even be pre-configured before delivery to a customer, to provide a turn-key solution for a particular application. Unlike general purpose computers, appliances are generally not designed to allow the customers to change the software and the underlying operating system, or to flexibly reconfigure the hardware.
BioAPI is a key part of the International Standards that support systems that perform biometric enrollment and verification. It defines interfaces between modules that enable software from multiple vendors to be integrated together to provide a biometrics application within a system, or between one or more systems using a defined Biometric Interworking Protocol (BIP) – see below.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
Medical equipment management is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare technology. These healthcare technology managers are, much like other healthcare professionals referred to by various specialty or organizational hierarchy names.
Functional safety is the part of the overall safety of a system or piece of equipment that depends on automatic protection operating correctly in response to its inputs or failure in a predictable manner (fail-safe). The automatic protection system should be designed to properly handle likely human errors, systematic errors, hardware failures and operational/environmental stress.
The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
Parasoft C/C++test is an integrated set of tools for testing C and C++ source code that software developers use to analyze, test, find defects, and measure the quality and security of their applications. It supports software development practices that are part of development testing, including static code analysis, dynamic code analysis, unit test case generation and execution, code coverage analysis, regression testing, runtime error detection, requirements traceability, and code review. It's a commercial tool that supports operation on Linux, Windows, and Solaris platforms as well as support for on-target embedded testing and cross compilers.
Cantata++, or simply Cantata in newer versions, is a commercial computer program for dynamic testing, specifically unit testing and integration testing, and code coverage at run time of C and C++ programs. It is developed and sold by QA Systems, and was formerly a product of IPL Information Processing Ltd.
Operational Technology (OT) is hardware and software that detects or causes a change, through the direct monitoring and/or control of industrial equipment, assets, processes and events. The term has become established to demonstrate the technological and functional differences between traditional IT systems and Industrial Control Systems environment, the so-called "IT in the non-carpeted areas". Examples of operational technology include:
Software installed in medical devices is assessed for health and safety issues according to international standards.
References
- ↑ Felix Redmill (2001). "The COTS Debate in Perspective" . In Udo Voges (ed.). Proceedings of the 20th International Conference on Computer Safety, Reliability and Security, SAFECOMP 2001, Budapest, Hungary, September 26–28, 2001. Springer. pp. 122. ISBN 978-3-540-42607-3.
- ↑ Hall, Ken (June 1, 2010). "Developing Medical Device Software to IEC 62304". EMDT - European Medical Device Technology. Retrieved 2012-12-11.
- ↑ Hobbs, Chris (2011-11-01). "Device makers can take COTS, but only with clear SOUP". Medical Design. Archived from the original on 2013-01-23.
