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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] |
Technical Standard
A technical standard is an established norm or requirement for a repeatable technical task which is applied to a common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices. A technical standard includes definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, performance, designs, or operations; measurement of quality and quantity in describing materials, processes, products, systems, services, or practices; test methods and sampling procedures; or descriptions of fit and measurements of size or strength. It is usually a formal document that establishes uniform engineering or technical criteria, methods, processes, and practices. In contrast, a custom, convention, company product, corporate standard, and so forth that becomes generally accepted and dominant is often called a ''de facto'' standard. A techni ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Product Life Cycle Management
Product life-cycle management (PLM) is the succession of strategies by business management as a product goes through its life-cycle. The conditions in which a product is sold (advertising, saturation) changes over time and must be managed as it moves through its succession of stages. Goals The goals of product life cycle management (PLM) are to reduce time to market, improve product quality, reduce prototyping costs, identify potential sales opportunities and revenue contributions, maintain and sustain operational serviceability, and reduce environmental impacts at end-of-life. To create successful new products the company must understand its customers, markets and competitors. Product Lifecycle Management (PLM) integrates people, data, processes and business systems. It provides product information for companies and their extended supply chain enterprise. PLM solutions help organizations overcome the increased complexity and engineering challenges of developing new products for ... [...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] |
New Zealand
New Zealand ( mi, Aotearoa ) is an island country in the southwestern Pacific Ocean. It consists of two main landmasses—the North Island () and the South Island ()—and over 700 smaller islands. It is the sixth-largest island country by area, covering . New Zealand is about east of Australia across the Tasman Sea and south of the islands of New Caledonia, Fiji, and Tonga. The country's varied topography and sharp mountain peaks, including the Southern Alps, owe much to tectonic uplift and volcanic eruptions. New Zealand's capital city is Wellington, and its most populous city is Auckland. The islands of New Zealand were the last large habitable land to be settled by humans. Between about 1280 and 1350, Polynesians began to settle in the islands and then developed a distinctive Māori culture. In 1642, the Dutch explorer Abel Tasman became the first European to sight and record New Zealand. In 1840, representatives of the United Kingdom and Māori chiefs ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Australia
Australia, officially the Commonwealth of Australia, is a Sovereign state, sovereign country comprising the mainland of the Australia (continent), Australian continent, the island of Tasmania, and numerous List of islands of Australia, smaller islands. With an area of , Australia is the largest country by area in Oceania and the world's List of countries and dependencies by area, sixth-largest country. Australia is the oldest, flattest, and driest inhabited continent, with the least fertile soils. It is a Megadiverse countries, megadiverse country, and its size gives it a wide variety of landscapes and climates, with Deserts of Australia, deserts in the centre, tropical Forests of Australia, rainforests in the north-east, and List of mountains in Australia, mountain ranges in the south-east. The ancestors of Aboriginal Australians began arriving from south east Asia approximately Early human migrations#Nearby Oceania, 65,000 years ago, during the Last Glacial Period, last i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Japan
Japan ( ja, 日本, or , and formally , ''Nihonkoku'') is an island country in East Asia. It is situated in the northwest Pacific Ocean, and is bordered on the west by the Sea of Japan, while extending from the Sea of Okhotsk in the north toward the East China Sea, Philippine Sea, and Taiwan in the south. Japan is a part of the Ring of Fire, and spans Japanese archipelago, an archipelago of List of islands of Japan, 6852 islands covering ; the five main islands are Hokkaido, Honshu (the "mainland"), Shikoku, Kyushu, and Okinawa Island, Okinawa. Tokyo is the Capital of Japan, nation's capital and largest city, followed by Yokohama, Osaka, Nagoya, Sapporo, Fukuoka, Kobe, and Kyoto. Japan is the List of countries and dependencies by population, eleventh most populous country in the world, as well as one of the List of countries and dependencies by population density, most densely populated and Urbanization by country, urbanized. About three-fourths of Geography of Japan, the c ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Canada
Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by total area. Its southern and western border with the United States, stretching , is the world's longest binational land border. Canada's capital is Ottawa, and its three largest metropolitan areas are Toronto, Montreal, and Vancouver. Indigenous peoples have continuously inhabited what is now Canada for thousands of years. Beginning in the 16th century, British and French expeditions explored and later settled along the Atlantic coast. As a consequence of various armed conflicts, France ceded nearly all of its colonies in North America in 1763. In 1867, with the union of three British North American colonies through Confederation, Canada was formed as a federal dominion of four provinces. This began an accretion of provinces an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territories, nine Minor Outlying Islands, and 326 Indian reservations. The United States is also in free association with three Pacific Island sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau. It is the world's third-largest country by both land and total area. It shares land borders with Canada to its north and with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the most populous country in the Americas and the third most populous in the world. The national capital of the United States is Washington, D.C. and its most populous city and principal financial center is New York City. Paleo-Americ ... [...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 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] |
Manufacturers
Manufacturing is the creation or production of goods with the help of equipment, labor, machines, tools, and chemical or biological processing or formulation. It is the essence of secondary sector of the economy. The term may refer to a range of human activity, from handicraft to high-tech, but it is most commonly applied to industrial design, in which raw materials from the primary sector are transformed into finished goods on a large scale. Such goods may be sold to other manufacturers for the production of other more complex products (such as aircraft, household appliances, furniture, sports equipment or automobiles), or distributed via the tertiary industry to end users and consumers (usually through wholesalers, who in turn sell to retailers, who then sell them to individual customers). Manufacturing engineering is the field of engineering that designs and optimizes the manufacturing process, or the steps through which raw materials are transformed into a final product. T ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Siemens Healthineers
Siemens Healthineers AG (formerly Siemens Healthcare, Siemens Medical Solutions, Siemens Medical Systems) is a German medical device company. It is the parent company for several medical technology companies and is headquartered in Erlangen, Germany. The company dates its early beginnings in 1847 to a small family business in Berlin, co-founded by Werner von Siemens. Siemens Healthineers is connected to the larger corporation, Siemens AG. The name Siemens Medical Solutions was adopted in 2001, and the change to Siemens Healthcare was made in 2008. In 2015, Siemens named Bernd Montag as its new global CEO. In May 2016, the business operations of Siemens Healthcare GmbH were rebranded "Siemens Healthineers." Globally, the companies owned by Siemens Healthineers have 65,000 employees. History 19th century The history of Siemens Healthineers started in Berlin in the mid-19th century as a part of what is now known as Siemens AG. Siemens & Halske was founded by Werner von Siemens ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
