Related Research Articles
Safety engineering is an engineering discipline which assures that engineered systems provide acceptable levels of safety. It is strongly related to industrial engineering/systems engineering, and the subset system safety engineering. Safety engineering assures that a life-critical system behaves as needed, even when components fail.
A safety-critical system or life-critical system is a system whose failure or malfunction may result in one of the following outcomes:
Medical software is any software item or system used within a medical context, such as reducing the paperwork, tracking patient activity
ISO/IEC 15504Information technology – Process assessment, also termed Software Process Improvement and Capability dEtermination (SPICE), is a set of technical standards documents for the computer software development process and related business management functions. It is one of the joint International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) standards, which was developed by the ISO and IEC joint subcommittee, ISO/IEC JTC 1/SC 7.
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.
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.
In functional safety, safety integrity level (SIL) is defined as the relative level of risk-reduction provided by a safety instrumented function (SIF), i.e. the measurement of the performance required of the SIF.
Information security standards are techniques generally outlined in published materials that attempt to protect a user's or organization's cyber environment. This environment includes users themselves, networks, devices, all software, processes, information in storage or transit, applications, services, and systems that can be connected directly or indirectly to networks.
IEC 61508 is an international standard published by the International Electrotechnical Commission (IEC) 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.
Software safety is an engineering discipline that aims to ensure that software, which is used in safety-related systems, does not contribute to any hazards such a system might pose. There are numerous standards that govern the way how safety-related software should be developed and assured in various domains. Most of them classify software according to their criticality and propose techniques and measures that should be employed during the development and assurance:
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 systematic errors, hardware failures and operational/environmental stress.
ISO 14971Medical devices — Application of risk management to medical devices is a voluntary consensus standard, published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
ISO 26262, titled "Road vehicles – Functional safety", is an international standard for functional safety of electrical and/or electronic systems that are installed in serial production road vehicles, defined by the International Organization for Standardization (ISO) in 2011, and revised in 2018.
IEC 62304 – medical device software – software life cycle processes is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices. It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements.
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.
CEBEC is a private Belgian rating label for the quality assurance of electrical appliances. Use of this label indicates that a piece of equipment conforms to European safety standards. The label is issued by SGS-CEBEC, now part of the SGS group. CEBEC has its own electrical testing laboratory located in Brussels. It is an approved laboratory for the purpose of certifications granted by SGS.
Cantata++, commonly referred to as Cantata in newer versions, is a commercial computer program designed for dynamic testing, with a focus on unit testing and integration testing, as well as run time code coverage analysis for C and C++ programs. It is developed and marketed by QA Systems, a multinational company with headquarters in Waiblingen, Germany.
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.
