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21-451: The main purpose of the GMDN is to provide health authorities / regulators, health care providers, conformity assessment bodies and others with a single generic naming system. Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225. The GMDN meets the need to identify medical devices at

42-573: A GMDN term by medical condition or product feature. The GMDN is used by regulators, healthcare providers and others for activities such as medical device recalls, adverse event reporting and postmarket surveillance and monitoring, as well as inventory control and other healthcare management functions. The GMDN Agency updates the GMDN utilizing member change requests, to add a new generic device term or to change an existing Term Name or Definition. The decisions are made by an international expert team, according to ISO 15225. The GMDN Agency releases updates to

63-758: A country's conformance testing requirements. Additionally, these agreements have the advantage of increasing confidence in conformance assessment bodies (e.g., testing labs and certification bodies), and by extension, product quality. An example is the IAF MLA which is an agreement for the mutual recognition of accredited certification between IAF Accreditation Body (AB) Member signatories. Test functions for optimization In applied mathematics, test functions , known as artificial landscapes , are useful to evaluate characteristics of optimization algorithms, such as convergence rate , precision, robustness and general performance. Here some test functions are presented with

84-425: A local radio station or interference from nearby products. Safety tests ensure that a product will not create a safety risk from situations such as a failed or shorted power supply, blocked cooling vent, and powerline voltage spikes and dips. For example, Ericsson 's telecommunications research and development subsidiary Telcordia Technologies publishes conformance standards for telecommunication equipment to pass

105-501: A product performs according to its specified standards. Compilers , for instance, are extensively tested to determine whether they meet the recognized standard for that language. In electronic engineering and electrical engineering , some countries and business environments (such as telecommunication companies) require that an electronic product meet certain requirements before they can be sold. Standards for telecommunication products written by standards organizations such as ANSI ,

126-467: A product within its ARTG system The GMDN Agency has established long term cooperation with the IHTSDO . The Cooperation Agreement shall result in the use of the GMDN as the medical device component of SNOMED CT . This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation. The following objectives were agreed: The Agreement will benefit patients across

147-469: A specific Term Name and Definition, with which all specific medical devices having substantially similar generic features, can be identified. The following is an example: The GMDN term and other associated data is copyright protected and the GMDN is a Trademark . Uniquely each GMDN term has a set of attributes, known as Collective Terms, which help to navigate the GMDN Database and aid the selection of

168-504: Is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification , technical standard , contract , or regulation . Testing is often either logical testing or physical testing . The test procedures may involve other criteria from mathematical testing or chemical testing . Beyond simple conformance, other requirements for efficiency, interoperability, or compliance may apply. Conformance testing may be undertaken by

189-536: Is realized after a product passes a series of tests without occurring some specified mode of failure. Compliance testing for electronic devices include emissions tests, immunity tests, and safety tests. Emissions tests ensure that a product will not emit harmful electromagnetic interference in communication and power lines. Immunity tests ensure that a product is immune to common electrical signals and electromagnetic interference (EMI) that will be found in its operating environment, such as electromagnetic radiation from

210-478: The FCC , and IEC have certain criteria that a product must meet before compliance is recognized. In countries such as Japan, China, Korea, and some parts of Europe, products cannot be sold unless they are known to meet those requirements specified in the standards. Usually, manufacturers set their own requirements to ensure product quality, sometimes with levels much higher than what the governing bodies require. Compliance

231-579: The GMDN on a daily basis, on their interactive website, the GMDN Database. Only Members have access to the GMDN Database. Since 1 April 2019 GMDN membership and therefore access to GMDN Terms and Codes has been free of any charge. The GMDN is available in English and other languages. The GMDN is part of the 'minimum data set' of the US FDA Unique Device Identification regulation for the registration of new Medical Devices intended for use in

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252-731: The United States. This follows the international consensus established by the International Medical Device Regulators Forum (IMDRF). The GMDN is required by the UK's national medical device regulator, the Medicines and Healthcare products Regulatory Agency The government agency responsible for medical device safety in Australia Therapeutic Goods Administration require the GMDN when registering

273-538: The aim of giving an idea about the different situations that optimization algorithms have to face when coping with these kinds of problems. In the first part, some objective functions for single-objective optimization cases are presented. In the second part, test functions with their respective Pareto fronts for multi-objective optimization problems (MOP) are given. The artificial landscapes presented herein for single-objective optimization problems are taken from Bäck, Haupt et al. and from Rody Oldenhuis software. Given

294-477: The certification body's website, to assure quality to the end user and that competing suppliers are on the same level. Aside from the various types of testing, related conformance testing activities include: The UK government identifies three forms of testing or assessment: Conformance testing is applied in various industries where a product or service must meet specific quality and/or regulatory standards. This includes areas such as: In all such testing,

315-561: The following tests: Several international standards relating to conformance testing are published by the International Organization for Standardization (ISO) and covered in the divisions of ICS 03.120.20 for management and ICS 23.040.01 for technical. Other standalone ISO standards include: Many countries sign mutual recognition agreements (MRAs) with other countries in order to promote trade of and facilitate market access to goods and services, while making it easier to meet

336-587: The global level, as identified in the Global Harmonization Task Force (GHTF) that have since disbanded (2012) and replaced by the IMDRF GMDN is managed by the GMDN Agency, a non-profit organization and Registered Charity , which reports to its Board of Trustees, that represent medical device regulators and industry. The GMDN term is in the form of a 5-digit numeric GMDN Code cross-referenced to

357-457: The number of problems (55 in total), just a few are presented here. The test functions used to evaluate the algorithms for MOP were taken from Deb, Binh et al. and Binh. The software developed by Deb can be downloaded, which implements the NSGA-II procedure with GAs, or the program posted on Internet, which implements the NSGA-II procedure with ES. Just a general form of the equation, a plot of

378-1603: The objective function, boundaries of the object variables and the coordinates of global minima are given herein. where:  A = 10 {\displaystyle {\text{where: }}A=10} − exp ⁡ [ 0.5 ( cos ⁡ 2 π x + cos ⁡ 2 π y ) ] + e + 20 {\displaystyle -\exp \left[0.5\left(\cos 2\pi x+\cos 2\pi y\right)\right]+e+20} + ( 2.625 − x + x y 3 ) 2 {\displaystyle +\left(2.625-x+xy^{3}\right)^{2}} [ 30 + ( 2 x − 3 y ) 2 ( 18 − 32 x + 12 x 2 + 48 y − 36 x y + 27 y 2 ) ] {\displaystyle \left[30+\left(2x-3y\right)^{2}\left(18-32x+12x^{2}+48y-36xy+27y^{2}\right)\right]} + ( y − 1 ) 2 ( 1 + sin 2 ⁡ 2 π y ) {\displaystyle +\left(y-1\right)^{2}\left(1+\sin ^{2}2\pi y\right)} or, similarly, f ( x 1 , x 2 , . . . , x n − 1 , x n ) = ∑ i = 1 m ( c i + ∑ j = 1 n ( x j −

399-447: The producer of the product or service being assessed, by a user, or by an accredited independent organization, which can sometimes be the author of the standard being used. When testing is accompanied by certification , the products or services may then be advertised as being certified in compliance with the referred technical standard . Manufacturers and suppliers of products and services rely on such certification including listing on

420-465: The subject of test is not just the formal conformance in aspects of completeness of filed proofs, validity of referred certificates, and qualification of operating staff. Rather, it also heavily focuses on operational conditions, physical conditions, and applied test environments. By extension conformance testing leads to a vast set of documents and files that allow for reiterating all performed tests. In software testing , conformance testing verifies that

441-493: The world and all users of SNOMED CT and the GMDN in promoting comprehensive terminology based medical records, covering the needs of regulators, the medical device industry and healthcare professionals. The arrangement will enhance the application of care to individual patients for medical device, patient risk and safety use cases. Conformity assessment Conformance testing — an element of conformity assessment , and also known as compliance testing , or type testing —

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