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IEC 62304
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. Implications of IEC 62304 for software The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance). The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used. Contents General requirements * Quality management system * Risk management * Software safety classification Software development process * Software development planning * Software requirements analysis ... [...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 (F ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
List Of IEC Standards
This is an incomplete list of standards published by the International Electrotechnical Commission (IEC). The numbers of older IEC standards were converted in 1997 by adding 60000; for example IEC 27 became IEC 60027. IEC standards often have multiple sub-part documents; only the main title for the standard is listed here. * IEC 60027 Letter symbols to be used in electrical technology * IEC 60028 International standard of resistance for copper * IEC 60034 Rotating electrical machines * IEC 60038 IEC Standard Voltages * IEC 60041 Field acceptance tests to determine the hydraulic performance of hydraulic turbines, storage pumps and pump-turbines * IEC 60044 Instrument transformers * IEC 60045 Steam turbines * IEC 60050 International Electrotechnical Vocabulary * IEC 60051 Direct acting indicating analogue electrical measuring instruments and their accessories * IEC 60052 Voltage measurement by means of standard air gaps * IEC 60055 Paper-insulated metal-sheathed cables for rated ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation Of Medical Devices
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restrictions ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
IEC Standards
This is an incomplete list of standards published by the International Electrotechnical Commission (IEC). The numbers of older IEC standards were converted in 1997 by adding 60000; for example IEC 27 became IEC 60027. IEC standards often have multiple sub-part documents; only the main title for the standard is listed here. * IEC 60027 Letter symbols to be used in electrical technology * IEC 60028 International standard of resistance for copper * IEC 60034 Rotating electrical machines * IEC 60038 IEC Standard Voltages * IEC 60041 Field acceptance tests to determine the hydraulic performance of hydraulic turbines, storage pumps and pump-turbines * IEC 60044 Instrument transformers * IEC 60045 Steam turbines * IEC 60050 International Electrotechnical Vocabulary * IEC 60051 Direct acting indicating analogue electrical measuring instruments and their accessories * IEC 60052 Voltage measurement by means of standard air gaps * IEC 60055 Paper-insulated metal-sheathed cables for rated ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Time-triggered System
Time-triggered architecture (abbreviated as TTA), also known as a time-triggered system, is a computer system that executes one or more sets of tasks according to a pre-determined and set task schedule.Pont, M.J. (2001) "Patterns for Time-Triggered Embedded Systems", Addison-Wesley / ACM Press. . Implementation of a TT system will typically involve use of a single interrupt that is linked to the periodic overflow of a timer. This interrupt may drive a task scheduler (a restricted form of real-time operating system). The scheduler willin turnrelease the system tasks at predetermined points in time. History and development Because they have highly deterministic timing behavior, TT systems have been used for many years to develop safety-critical aerospace and related systems.Ward, N. J. (1991) "The static analysis of a safety-critical avionics control system", in Corbyn, D.E. and Bray, N. P. (Eds.) "Air Transport Safety: Proceedings of the Safety and Reliability Society Spring Con ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CISQ
The Consortium for IT Software Quality (CISQ) is an IT industry group comprising IT executives from the Global 2000, systems integrators, outsourced service providers, and software technology vendors committed to making improvements in the quality of IT application software. Overview Jointly organized by the Software Engineering Institute (SEI) at Carnegie Mellon University and the Object Management Group (OMG), CISQ is designed to be a neutral forum in which customers and suppliers of IT application software can develop an industry-wide agenda of actions for defining, measuring, and improving IT software quality. History CISQ was launched in August 2009 by 24 founders including SEI and OMG. The founders of CISQ are Paul D. Nielsen, Director and CEO of SEI and Richard Mark Soley, Chairman and CEO of OMG. Bill Curtis, the co-author of the CMM framework is CISQ's first Director. Software measurement and productivity expert Capers Jones is a CISQ Distinguished Advisor. I ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO 9001
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test. ISO 9004 gives guidance on achieving sustained organizational success. Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. However, the ISO certification process has b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO 13485
ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016. Background Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO 14971
ISO 14971 ''Medical devices — Application of risk management to medical devices'' is a voluntary standard for the application of risk management to medical devices. "Voluntary standards do not replace national laws, with which standards' users are understood to comply and which take precedence" over voluntary standards such as ISO 13485 and ISO 14971. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971. Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production. ISO 14971:2012 was harmonized with respect ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
IEC 60601
IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission. First published in 1977 and regularly updated and restructured, as of 2011 it consists of a general standard, about 10 collateral standards, and about 80 particular standards. General standard The general standard ''IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance'' – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many countries. Many companies view compliance with IEC 60601-1 as a requirement for most markets. This standard does not assure effectiveness of a medical device. In the US, evidence of effectiveness is required by the FDA and conf ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software Quality
In the context of software engineering, software quality refers to two related but distinct notions: * Software functional quality reflects how well it complies with or conforms to a given design, based on functional requirements or specifications. That attribute can also be described as the fitness for purpose of a piece of software or how it compares to competitors in the marketplace as a worthwhile product. It is the degree to which the correct software was produced. * Software structural quality refers to how it meets non-functional requirements that support the delivery of the functional requirements, such as robustness or maintainability. It has a lot more to do with the degree to which the software works as needed. Many aspects of structural quality can be evaluated only statically through the analysis of the software inner structure, its source code (see Software metrics), at the unit level, system level (sometimes referred to as end-to-end testing), which is in effect ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software Life Cycle
A software release life cycle is the sum of the stages of development and maturity for a piece of computer software ranging from its initial development to its eventual release, and including updated versions of the released version to help improve the software or fix software bugs still present in the software. There are several models for such a life cycle. A common method is that suggested by Microsoft, which divides software development into five phases: Pre-alpha, Alpha, Beta, Release candidate, and Stable. Pre-alpha refers to all activities performed during the software project before formal testing. The alpha phase generally begins when the software is feature complete but likely to contain several known or unknown bugs. The beta phase generally begins when the software is deemed feature complete, yet likely to contain several known or unknown bugs. Software in the production phase will generally have many more bugs in it than completed software, as well as speed/performan ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
