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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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Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: 

Una lent intraocular (IOL) és una lent d'implantat en l'ull, normalment reemplaçant el cristal • lí existent perquè ha estat entelat per una cataracta, o com a forma de la cirurgia refractiva a canvi de potència òptica de l'ull. Normalment consta d'una lent de plàstic petita amb plàstic costat struts, anomenats haptics, per mantenir la lent en el lloc dins de la bossa capsular dins de l'ull.[edita] Lio tradicionalment es van fer d'un material inflexible (PMMA), encara que això en gran mesura ha estat substituïda per l'ús de materials flexibles. Més Lio equipat avui són lents fixa monofocal corresponen a vision de distància. No obstant això, altres tipus estan disponibles, com ara Lio multifocals que proporcionen el pacient amb visió múltiple-es va centrar a distància fins aquí i llegir i adaptable Lio que proporcionen el pacient amb allotjament visual limitat.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Implants & interventional materials

An intraocular lens (IOL) is an implanted lens in the eye, usually replacing the existing crystalline lens because it has been clouded over by a cataract, or as a form of refractive surgery to change the eye's optical power. It usually consists of a small plastic lens with plastic side struts, called haptics, to hold the lens in place within the capsular bag inside the eye.[citation needed] IOLs were traditionally made of an inflexible material (PMMA), although this has largely been superseded by the use of flexible materials. Most IOLs fitted today are fixed monofocal lenses matched to distance vision. However, other types are available, such as multifocal IOLs which provide the patient with multiple-focused vision at far and reading distance, and adaptive IOLs which provide the patient with limited visual accommodation.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Implants & interventional materials

Anell intracorneal Implants (INTACS) són una opció de correcció de visió a tractar a baix en un nivell moderat de la miopia. INTACS s'utilitzen per corregir la miopia en pacients que tenen Queratocon i aquells que tenen la miopia residual seguint làser refractiva o la cirurgia LASIK.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Implants & interventional materials

Intracorneal Ring Implants (INTACS) are a vision correction option to treat low to moderate levels of myopia. INTACS are used to correct myopia in patients who have keratoconus and those who have residual myopia following laser refractive or LASIK surgery.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Implants & interventional materials

L'envasament és la ciència, art i tecnologia de tancament o protecció de productes per a la distribució, emmagatzematge, Venda i ús. Envasament també es refereix al procés d'avaluació, disseny i producció de paquets. Envasament pot ser descrit com un sistema coordinat de preparació dels béns per al transport, emmagatzematge, logística, Venda i ús final. Envasament conté, protegeix, conserva, transporta, informa i ven.[1] A molts països plenament s'integra en el govern, empresarial, institucional, industrial i personal d'ús.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: 

Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages. Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use. Packaging contains, protects, preserves, transports, informs, and sells.[1] In many countries it is fully integrated into government, business, institutional, industrial, and personal use.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: 

"un manual normalment acompanyant un dispositiu tècnic i explicant com instal·lar o operar-lo" requisits imprescindibles - mèdic dispositiu directiva 93/42/EEC - Annex I, 13.1: cada dispositiu ha d'anar acompanyada de la informació necessària per utilitzar-lo de manera segura i identificar el fabricant, prendre compte de la formació i el coneixement de l'usuari potencial. Aquesta informació està formada pels detalls sobre l'etiqueta i les dades de les instruccions per utilitzar. Pel que fa a practicables i apropiat, la informació necessària per utilitzar el dispositiu amb seguretat cal definir en el propi dispositiu i/o en l'envasament de cada unitat. Si no practicables, la informació ha d'establir en el prospecte subministrat amb un o més mecanismes. Instruccions d'ús han de figurar en l'envasament per cada dispositiu. Manera excepcional, no tan prospecte instrucció és necessària per a dispositius a l'aula o classe IIa si es poden utilitzar completament segura sense cap d'aquestes instruccions.

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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