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Terminology used in the instructions for use for ophthalmic implants, surgical tools & instruments, OVDs, ophthalmic irrigating fluids

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Created by: Leoneska

Number of Blossarys: 1

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na medicina, indicação é uma razão válida para usar certo teste, medicação, procedimento ou cirurgia o seu oposto é chamado de contra-indicação

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Diseases; Hospitals; Diseases; Herbal medicine; Medicine; Implants & interventional materials

В медицине указание это веская причина для использования определенного теста, лекарства, процедуры или хирургии. Противоположностью индикация является противопоказанием.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Diseases; Hospitals; Diseases; Herbal medicine; Medicine; Implants & interventional materials

"um manual geralmente um dispositivo técnico de acompanhamento e explicando como instalar ou operá-lo" requisitos essenciais - médicos dispositivo da Directiva 93/42/CEE - Anexo I, 13.1: cada dispositivo deve ser acompanhado as informações necessárias para usá-lo com segurança e identificar o fabricante, tendo em conta a formação e conhecimento do potencial usuário. Esta informação inclui os detalhes sobre o rótulo e os dados nas instruções de uso. Tanto quanto possível e apropriado, a informação necessária para utilizar o dispositivo com segurança deve ser definida fora no próprio dispositivo e/ou na embalagem de cada unidade. Se não possível, a informação deve ser definida para fora no folheto fornecido com um ou mais dispositivos. Manual de instruções deve ser incluído na embalagem de cada dispositivo. Excepcionalmente, não há tal folheto de instruções é necessária para dispositivos de classe I ou classe II se completamente com segurança podem ser usados sem qualquer tais instruções.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Biochemistry; Biofuel; Biomedical; Behavioral science; Cancer treatment; Dentistry; Diseases; Hematology; Hospitals; Medical research; Nursing homes; Psychiatry; Vaccines; Regulatory; Herbal medicine; Histology; Medicine; Cardiac supplies; Clinical analytical instruments; Clinical trials; Dental equipment; Dermatology instruments; Emergency room apparatus; ENT instruments; Eye instruments; General assay & diagnostic instruments; Implants & interventional materials; Medical cryogenic equipment; OBGYN equipment; Orthopaedic supplies; Pharmacology instruments; Physical therapy equipment; Radiology equipment; Sterilization equipment; Surgical instruments; Ultrasonic & optical equipment; Ward nursing equipment

"a manual usually accompanying a technical device and explaining how to install or operate it" Essential Requirements - Medical Device Directive 93/42/EEC - Annex I, 13.1: Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential user. This information comprises the details on the label and the data in the instructions for use. As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging of each unit. If not practicable, the information must be set out in the leaflet supplied with one or more devices. Instructions for use must be included in the packaging for every device. By way of exception, no such instruction leaflet is needed for devices in Class I or Class IIa if they can be used completely safely without any such instructions.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Biochemistry; Biofuel; Biomedical; Behavioral science; Cancer treatment; Dentistry; Diseases; Hematology; Hospitals; Medical research; Nursing homes; Psychiatry; Vaccines; Regulatory; Herbal medicine; Histology; Medicine; Cardiac supplies; Clinical analytical instruments; Clinical trials; Dental equipment; Dermatology instruments; Emergency room apparatus; ENT instruments; Eye instruments; General assay & diagnostic instruments; Implants & interventional materials; Medical cryogenic equipment; OBGYN equipment; Orthopaedic supplies; Pharmacology instruments; Physical therapy equipment; Radiology equipment; Sterilization equipment; Surgical instruments; Ultrasonic & optical equipment; Ward nursing equipment

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