accessory for a medical device definition

accessory for a medical device means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
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accessory for a medical device means an article which, whilst not being itself a medical device, is
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accessory for a medical device means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s); fff) Tıbbi cihaz aksesuarı: Kendi başına bir tıbbi cihaz olmadığı halde, özellikle tıbbi cihaz(lar)ın kullanım amacına/amaçlarına uygun olarak kullanılmasını mümkün kılmak ya da tıbbi cihaz(lar)ın kullanım amacı/amaçları bakımından tıbbi işlevselliğine doğrudan ve spesifik olarak yardımcı olmak üzere imalatçısı tarafından bir ya da birden fazla belirli tıbbi cihazla birlikte kullanımı amaçlanan parçayı,
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More Definitions of accessory for a medical device

accessory for a medical device means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or more particular medical devices and:
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accessory for a medical device means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intendedpurpose(s); fff) Tıbbi cihaz aksesuarı: Kendi başına bir tıbbi cihaz olmadığı halde, özellikle tıbbi cihaz/cihazların kullanım amacına/amaçlarına uygun olarak kullanılmasını mümkün kılmak ya da tıbbi cihaz/cihazların kullanım amacı/amaçları bakımından tıbbi işlevselliğine doğrudan ve spesifik olarak yardımcı olmak üzere imalatçısı tarafından bir ya da birden fazla belirli tıbbi cihazla birlikte kullanımı amaçlanan parçayı, (17) ‘derivative’ means a ‘non-cellular substance’ extracted from human or animaltissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues; ggg) Türev: Bir imalat süreci vasıtasıyla insan veya hayvan dokularından ya dahücrelerinden ekstrakte edilmiş hücresel olmayan ve dolayısıyla hiçbir hücre veya doku içermeyen maddeyi, (41) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification andinspection; ğğğ) Uygunluk değerlendirme kuruluşu: Kalibrasyon, test, belgelendirme ve muayene dâhil olmak üzere, üçüncü taraf uygunluk değerlendirme faaliyetleriniyürüten kuruluşu, (40) ‘conformity assessment’ means the process demonstrating whether therequirements of this Regulation relating to a device have been fulfilled; hhh) Uygunluk değerlendirmesi: Bir cihazla ilgili bu Yönetmeliğin gerekliliklerininyerine getirilip getirilmediğini gösteren süreci, (70) ‘harmonised standard’ means a European standard as defined in point (1)(c) ofArticle 2 of Regulation (EU) No 1025/2012; ııı) Uyumlaştırılmış standart: Uyumlaştırılmış Avrupa Birliği Mevzuatını uygulamakamacıyla Komisyon’un talebine istinaden kabul edilen bir Avrupa standardını, (25) ‘compatibility’ is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:(a) perform without losing or compromising the ability to perform as intended, and/or
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Related to accessory for a medical device

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Information Technology (IT) System means the combination of hardware components, software, and other equipment to make a system whose core purpose is to accomplish a data processing need such as the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission or reception of data. IT systems include ground systems in support of flight hardware. IT systems do not include—

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Assistive technology device means any item, piece of equipment, or product system that is used to increase, maintain, or improve the functional capacities of a child with a disability.

  • National Medical Support Notice or “NMSN” shall mean a notice that contains the following information:

  • Information Technology (IT means data processing, telecommunications, and office systems technologies and services:

  • Information technology services means services designed to do any of the following:

  • Information Technology Resources means agency budgetary resources, personnel, equipment, facilities, or services that are primarily used in the management, operation, acquisition, disposition, and transformation, or other activity related to the lifecycle of information technology; acquisitions or interagency agreements that include information technology and the services or equipment provided by such acquisitions or interagency agreements; but does not include grants to third parties which establish or support information technology not operated directly by the Federal Government. (0MB M-15-14)

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Access Device means a card, plate, code, account number, per- sonal identification number, electronic serial number, mobile identi- fication number, or other telecommunications service, equipment, or instrument identifier or means of account access that alone or in conjunction with another device may be used to:

  • Control device means equipment (such as an incinerator or carbon adsorber) used to reduce, by destruction or removal, the amount of air contaminants in an air stream prior to discharge to the ambient air.

  • Information Technology Systems means all information technology systems, Software, computers, workstations, databases, routers, hubs, switches, networks and other information technology equipment used or held for use in, or otherwise relating to, the Business.

  • Pharmaceutical care means the provision of drug therapy and

  • Secondary Systems means control or power circuits that operate below 600 volts, AC or DC, including, but not limited to, any hardware, control or protective devices, cables, conductors, electric raceways, secondary equipment panels, transducers, batteries, chargers, and voltage and current transformers.

  • Traffic control device means a flagger, sign, signal, marking, or other device used to regulate, warn or guide traffic, placed on, over, or adjacent to a street, highway, private road open to public travel, pedestrian facility, or shared-use path by authority of a public agency or official having jurisdiction, or, in the case of a private road open to public travel, by authority of the private owner or private official having jurisdiction.