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IEC 62366
IEC 62366 medical devices - Application of usability engineering to medical devices is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies usability requirements for the development of medical devices. It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements. Summary of IEC 62366 The IEC 62366 standard calls out the errors caused by inadequate medical device usability have become an increasing cause for concern. IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not apply to clinical decision-making that may be related to the use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability. Manufacturers of medical electrical equipment who comply with IEC 60601-1-6 need to also ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices
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 (FD& ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Standard
international standard is a technical standard developed by one or more international standards organizations. International standards are available for consideration and use worldwide. The most prominent such organization is the International Organization for Standardization (ISO). Other prominent international standards organizations including the International Telecommunication Union (ITU) and the International Electrotechnical Commission (IEC). Together, these three organizations have formed the World Standards Cooperation alliance. Purpose International standards may be used either by direct application or by a process of modifying an international standard to suit local conditions. Adopting international standards results in creating national standards that are equivalent, or substantially the same as international standards in technical content, but may have (i) editorial differences as to appearance, use of symbols and measurement units, substitution of a point for a com ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Electrotechnical Commission
The International Electrotechnical Commission (IEC; in French: ''Commission électrotechnique internationale'') is an international standards organization that prepares and publishes international standards for all electrical, electronic and related technologies – collectively known as "electrotechnology". IEC standards cover a vast range of technologies from power generation, transmission and distribution to home appliances and office equipment, semiconductors, fibre optics, batteries, solar energy, nanotechnology and marine energy as well as many others. The IEC also manages four global conformity assessment systems that certify whether equipment, system or components conform to its international standards. All electrotechnologies are covered by IEC Standards, including energy production and distribution, electronics, magnetics and electromagnetics, electroacoustics, multimedia, telecommunication and medical technology, as well as associated general disciplines such as t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Gold Standard (test)
In medicine and statistics, a gold standard test is usually the diagnostic test or benchmark that is the best available under reasonable conditions. In other words, a gold standard is the most accurate test possible without restrictions. Both meanings are different because for example, in medicine, dealing with conditions that would require an autopsy to have a perfect diagnosis, the gold standard test would be the best one that keeps the patient alive instead of the autopsy. In medicine "Gold standard" can refer to the criteria by which scientific evidence is evaluated. For example, in resuscitation research, the "gold standard" test of a medication or procedure is whether or not it leads to an increase in the number of neurologically intact survivors that walk out of the hospital.''ACLS: Principles and Practice''. p. 62. Dallas: American Heart Association, 2003. . Other types of medical research might regard a significant decrease in 30-day mortality as the gold standard. The ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory Compliance
In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Compliance has traditionally been explained by reference to the deterrence theory, according to which punishing a behavior will decrease the violations both by the wrongdoer (specific deterrence) and by others (general deterrence). This view has been supported by economic theory, which has framed punishment in terms of costs and has explained compliance in terms of a cost-benefit equilibrium (Becker 1968). However, psychological research on motivation provides an alternative view: granting rewards (Deci, Koestner and Ryan, 1999) or imposing fines (Gneezy Rustichini 2000) for a certain behavior is a form of extrinsic motivation that weakens intrinsic motivation and ultimately undermines compliance. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and ... [...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] |
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] |
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] |
