IEC 60601-1
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IEC 60601-1
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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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