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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] |
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] |
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/IEC Guide 51
ISO/IEC JTC 1, entitled "Information technology", is a joint technical committee (JTC) of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Its purpose is to develop, maintain and promote standards in the fields of information and communications technology (ICT). JTC 1 has been responsible for many critical IT standards, ranging from the Joint Photographic Experts Group (JPEG) image formats and Moving Picture Experts Group (MPEG) audio and video formats to the C and C++ programming languages. History ISO/IEC JTC 1 was formed in 1987 as a merger between ISO/TC 97 (Information Technology) and IEC/TC 83, with IEC/SC 47B joining later. The intent was to bring together, in a single committee, the IT standardization activities of the two parent organizations in order to avoid duplicative or possibly incompatible standards. At the time of its formation, the mandate of JTC 1 was to develop base standards in information tec ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO/IEC Guide 63
ISO/IEC JTC 1, entitled "Information technology", is a joint technical committee (JTC) of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Its purpose is to develop, maintain and promote standards in the fields of information and communications technology (ICT). JTC 1 has been responsible for many critical IT standards, ranging from the Joint Photographic Experts Group (JPEG) image formats and Moving Picture Experts Group (MPEG) audio and video formats to the C and C++ programming languages. History ISO/IEC JTC 1 was formed in 1987 as a merger between ISO/TC 97 (Information Technology) and IEC/TC 83, with IEC/SC 47B joining later. The intent was to bring together, in a single committee, the IT standardization activities of the two parent organizations in order to avoid duplicative or possibly incompatible standards. At the time of its formation, the mandate of JTC 1 was to develop base standards in information tec ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices Directive
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificat ... applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised direct ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Committee For Standardization
The European Committee for Standardization (CEN, french: Comité Européen de Normalisation) is a public standards organization whose mission is to foster the economy of the European Single Market and the wider European continent in global trading, the welfare of European citizens and the environment by providing an efficient infrastructure to interested parties for the development, maintenance and distribution of coherent sets of standards and specifications. The CEN was founded in 1961. Its thirty-four national members work together to develop European Standards (ENs) in various sectors to build a European internal market for goods and services and to position Europe in the global economy. CEN is officially recognized as a European standards body by the European Union, European Free Trade Association and the United Kingdom; the other official European standards bodies are the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunicati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
List Of ISO Standards
A ''list'' is any set of items in a row. List or lists may also refer to: People * List (surname) Organizations * List College, an undergraduate division of the Jewish Theological Seminary of America * SC Germania List, German rugby union club Other uses * Angle of list, the leaning to either port or starboard of a ship * List (information), an ordered collection of pieces of information ** List (abstract data type), a method to organize data in computer science * List on Sylt, previously called List, the northernmost village in Germany, on the island of Sylt * ''List'', an alternative term for ''roll'' in flight dynamics * To ''list'' a building, etc., in the UK it means to designate it a listed building that may not be altered without permission * Lists (jousting), the barriers used to designate the tournament area where medieval knights jousted * ''The Book of Lists'', an American series of books with unusual lists See also * The List (other) * Listing (di ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Technology
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients. Development Pre-digital Era During a pre-digital era, patients suffered from inefficient and faulty clinical systems, processes, and conditions. Many medical errors happened in the past due to undeveloped health technologies. Some examples of these medical errors included adverse drug events and alarm fatigue. Alarm fatigue is caused when an alarm is repeatedly triggered or activated and one becomes d ... [...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] |
Clinical Engineering
Clinical engineering is a specialty within biomedical engineering responsible for using medical technology to optimize healthcare delivery. Clinical engineers train and supervise biomedical equipment technicians (BMETs), working with governmental regulators on hospital inspections and audits, and serve as technological consultants for other hospital staff (i.e., Physicians, Administrators, IT). Clinical engineers also assist manufacturers in improving the design of medical equipment and maintain state-of-the-art hospital supply chains. With training in both product design and point-of-use experience, clinical engineers bridge the gap between product developers and end-users. The focus on practical implementations tends to keep clinical engineers oriented towards incremental redesigns, as opposed to revolutionary or cutting-edge ideas far-off of implementation for clinical use. However, there is an effort to expand this time horizon, over which clinical engineers can influe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO 690
ISO 690 is an ISO standard governing bibliographic references in different kinds of documents, including electronic documents. This international standard specifies the bibliographic elements that need to be included in references to published documents, and the order in which these elements should be stated. Characteristics ISO 690 governs bibliographic references to published material in both print and non-print documents. The current version of the standard was published in 2021 and covers all kinds of information resources, including monographs, serials, contributions, patents, cartographic materials, electronic information resources (including computer software and databases), music, recorded sound, prints, photographs, graphic and audiovisual works, and moving images. ISO 690 ranks among a number of ISO standards that bear on academic publishing, such as ISO 214, which establishes rules for abstracts; ISO 2145, which deals with numbering of divisions and subdivisions of wr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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