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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

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In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect, and may result from an unsuitable or incorrect dosage or procedure, which could be due to medical error. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects only occur only when starting, increasing or discontinuing a treatment. Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause medical complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen. The harmful outcome is usually indicated by some result such as morbidity, mortality, alteration in body weight, levels of enzymes, loss of function, or as a pathological change detected at the microscopic, macroscopic or physiological level. It may also be indicated by symptoms reported by a patient. Adverse effects may cause a reversible or irreversible change, including an increase or decrease in the susceptibility of the individual to other chemicals, foods, or procedures, such as drug interactions. In clinical trials, a distinction is made between adverse events (AEs) and serious adverse events (SAEs). Generally, any event which causes death, permanent damage, birth defects, or requires hospitalization is considered an SAE.[1] The results of these trials are often included in the labeling of the medication to provide information both for patients and the prescribing physicians.

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

În medicină, un efect advers este un efect periculos și nedorit care rezultă dintr-o medicație sau din altă intervenție cum ar fi intervenția chirurgicală. Un efect advers poate fi definit ca \"efect secundar\" atunci când este considerat a fi secundar unui efect terapeutic sau principal și poate rezulta din dozarea sau procedura nepotrivită sau incorectă ce se poate datora unei erori medicale. Efectele adverse sunt considerate a fi \"iatrogenice\" deoarece sunt generate de către medic/tratament. Unele efecte adverse apar numai la început, crescând sau întrerupând un tratament. Folosirea unui medicament sau a altei intervenții medicale care este contraindicată poate crește riscul efectelor adverse. Efectele adverse pot determina complicații medicale ale bolii sau ale procedurii și îi afectează negativ prognoza. Ele pot de asemenea să conducă la neacceptarea unui regim de tratament. Rezultatul nociv este indicat de obicei, de unele urmări cum ar fi morbiditatea, mortalitatea, deteriorarea greutății corpului, nivelul enzimelor, pierderea funcțiilor sau o schimbare patologică depistată la nivel microscopic, macroscopic sau fiziologic. Poate de asemenea fi indicat de simptome raportate de către pacient. Efectele adverse pot cauza o schimbare reversibilă sau ireversibilă incluzând o creștere sau o descreștere a susceptibilității individului la alte chimicale, alimente sau proceduri, cum ar fi interacțiunile medicamentului. În studiile clinice se face o distincție între evenimentele adverse (EA) și evenimentele adverse serioase (EAS). În general, orice eveniment care provoacă moarte, daună permanentă, defecte la naștere sau care necesită spitalizare este considerat un EAS. Rezultatele acestor studii sunt incluse adeseori în prospectul medicamentului pentru a furniza informația atât pacientului cât și fizicianului care îl prescrie.

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

description a statement presenting something in words, from verb describe

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

Descriere o declaraţie ceva prezentarea în cuvinte, de la verbul descrie

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

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

Implanturi Intracorneal Ring (INTACS) sunt o opţiune de corecţie viziune pentru a trata scăzut la niveluri moderate de miopie. INTACS sunt utilizate pentru a corecta miopia la pacienţii care au keratoconus şi cei care au miopie reziduală următoarele refractiva cu laser sau chirurgie LASIK.

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

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: 

Ambalajul este ştiinţa, arta şi tehnologia de anexând sau de protecţie de produse pentru distributie, depozitarea, vânzarea, şi de a folosi. Ambalare, de asemenea, se referă la procesul de proiectare, evaluare, şi producţia de ambalaje. Ambalare poate fi descris ca un sistem coordonat de pregătirea mărfurilor pentru utilizare de transport, depozitare, logistica, vânzare, şi sfârşitul. Ambalaj contine, protejeaza, păstrează, transporturi, informează, şi vinde [1]. În multe ţări, este complet integrat în guvern, mediul de afaceri, utilizează instituţional, industrial, şi personale.

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

intraoperative complications, are complications, problems within operation, intraoperative problems.

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

complicaţii intraoperatorie, sunt complicatii, probleme în funcţionarea, probleme intraoperatorie.

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

complications that may arise following surgery

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

Complicaţiile care pot apărea după o intervenţie chirurgicală

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

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

Un lentile intraoculare (IOL) este un obiectiv implantat în ochi, de obicei înlocuirea cristalinul existente pentru că ea a fost umbrită de către o cataractă, sau ca o formă de chirurgie refracţie la schimbarea ochiului puterii optice. De obicei, constă dintr-un mic plastic lentilă cu bare laterale din plastic, numit haptics, să deţină lentilă în loc în sacul capsular din interiorul ochiului.[necesită citare] IOLs s-au făcut în mod tradiţional dintr-un material inflexibil (PMMA), deşi acest lucru a fost înlocuit în mare măsură de folosirea de materiale flexibile. IOLs cel mai dotat azi sunt fix monofocal lentile adaptate la distanţă viziune. Cu toate acestea, alte tipuri sunt disponibile, precum IOLs multifocale care asigură pacientul cu multiple-concentrat viziune la distanţă departe şi citirea şi IOLs adaptiv care asigură pacientul cu limitat de cazare vizuale.

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

In United States safety standards, precautionary statements are sentences providing information on potential hazards, and proper procedures. They are used in situations from consumer product on labels and manuals, to descriptions of physical activities. Various methods are used to bring focus to them, such as setting apart from normal text, graphic icons, changes in text's font and color. Texts will often clarify the types of statements and their meanings within the text. Common precautionary statements are described below.

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

În standardele de siguranță din Statele Unite, frazele de securitate sunt fraze care furnizează informația asupra pericolelor potențiale și a procedurilor corecte. ele sunt folosite în situații de la etichete și manuale ale produsului de consum până la descrierea activităților fizice. Pentru a atrage atenția asupra lor, astfel de semnalări separat de textul normal, imagini grafice, schimbări în fontul și culoarea textului. Adeseori textele vor clarifica tipurile de fraze și înțelesul lor în cadrul textului. Frazele de precauție obișnuite sunt descrise mai jos.

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

Dose means quantity in the following fields: In nutrition, medicine, and toxicology: * Dose (biochemistry), the quantity of something that may be eaten by or administered to an organism, or that an organism may be exposed to In medicine and toxicology: * Absorbed dose, an amount of radiation received * Dosing, the process of administering a measured amount of a medicine or chemical to an inanimate object or non-human animal * Effective dose, the smallest amount of a substance required to produce a measurable effect on a living organism * Equivalent dose, a measure of radiation dosage to tissue * Maximum tolerated dose, the highest dose of a radiological or pharmacological treatment that will produce the desired effect without unacceptable toxicity. * Optimal Biological Dose, the quantity of a radiological or pharmacological treatment that will produce the desired effect with acceptable toxicity. * Reference dose, the United States Environmental Protection Agency's maximum acceptable oral dose of a toxic substance Dosage is a synonym for the biochemical term dose!

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

Doza: cantitatea în următoarele domenii: în nutriţie, medicină şi toxicologie: * doza (Biochimie), cantitatea de ceva care poate fi mâncat de sau administrate la un organism, sau că un organism poate fi expus la în medicină şi toxicologie: * doza absorbita, o sumă de radiaţii primite * dozare, procesul de administrare o cantitate măsurată de un medicament sau chimice a unui obiect neînsufleţit sau animale non-umane * doza eficace, cea mai mică cantitate de substanță necesară pentru a produce un efect măsurabil pe un organism viu * doza echivalentă, o măsură a dozei de radiaţii la ţesutul * doza maximă tolerată, cea mai mare doză o radiologice sau farmacologice de tratament, care va produce efectul dorit fără toxicitate inacceptabile. * Optime dozei biologice, cantitatea de o radiologice sau farmacologice de tratament, care va produce efectul dorit cu toxicitate acceptabil. * Trimitere doza, Unite Statele Agenţia pentru protecţia mediului pe maxim acceptabil orală a unei substanțe toxice doza este un sinonim pentru doza biochimice termen!

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

In medicine, most medications can be safely used with other medicines, but particular combinations of medicines need to be monitored for interactions, often by the pharmacist. In molecular biology, the knowledge on gene/protein interaction among themselves and with their metabolites is referred to as molecular pathways. Interactions between medications (drug interactions) fall generally into one of two main categories: 1. pharmacodynamic : Involving the actions of the two interacting drugs. 2. pharmacokinetic : Involving the absorption, distribution, metabolism, and excretion of one or both of the interacting drugs upon the other. In terms of efficacy, there can be three types of interactions between medications: additive, synergistic, and antagonistic. Additive interaction means the effect of two chemicals is equal to the sum of the effect of the two chemicals taken separately. This is usually due to the two chemicals acting on the body in the same way. Examples would be Aspirin and Motrin, Alcohol and Depressant, Tranquilizer and Painkiller. Synergistic interaction means that the effect of two chemicals taken together is greater than the sum of their separate effect at the same doses. An example is Pesticide and Fertilizer, the biological effect is devastating. Antagonistic interaction means that the effect of two chemicals is actually less than the sum of the effect of the two drugs taken independently of each other. This is because the second chemical increases the excretion of the first, or even directly blocks its toxic actions. Antagonism forms the basis for antidotes of poisonings.

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

In medicina, cele mai multe medicamente poate fi utilizat cu alte medicamente, dar anumite combinaţii de medicamente trebuie să fie monitorizate pentru interacţiuni, adesea de către farmacist. În biologie moleculară, cunoştinţe pe gene/proteine interacţiune între ele şi cu metaboliților lor este menţionată ca moleculare căi. Interacţiunile dintre medicamente (interacţiuni de droguri) se încadrează în general în una dintre două categorii principale: 1. farmacodinamice: care implică acţiuni de două medicamente interacţionează. 2. farmacocinetice: care implică absorbţia, distribuţia, metabolismul şi excreţia de una sau ambele medicamente interacţionează la celelalte. În termeni de eficacitate, pot exista trei tipuri de interacţiuni între medicamente: aditive, sinergice şi antagonice. Aditiv interacţiunea înseamnă efectul a două substanţe chimice este egală cu suma de efectul de două substanţe chimice luate separat. Acest lucru se datorează de regulă două substanţe chimice acţionează pe corp în acelaşi mod. Exemple ar fi aspirina şi Motrin, alcool şi sedativ, tranchilizant si analgezic. Sinergice interacţiunea înseamnă că efectul a două substanţe chimice luate împreună este mai mare decât suma de efectul lor separată la aceleaşi doze. Un exemplu este Pesticide şi îngrăşăminte, efectul biologic este devastator. Antagoniste interacţiunea înseamnă că efectul a două substanţe chimice este de fapt mai mică decât suma de efectul a două medicamente luate independent unele de celelalte. Aceasta este deoarece chimice a doua creste excretia de primul, sau chiar direct blocuri acţiunile sale toxice. Antagonismul formează baza pentru antidoturi de intoxicaţii.

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

Complication, in medicine, is an unfavorable evolution of a disease, a health condition or a medical treatment. The disease can become worse in its severity or show a higher number of signs, symptoms or new pathological changes, become widespread throughout the body or affect other organ systems. A medical treatment, such as drugs or surgery may produce adverse effects and/or produce new health problem(s) by itself. A new disease may also appear as a complication to a previous existing disease. Therefore, a complication may be iatrogenic, i.e., literally brought forth by the physician. Medical knowledge about a disease, procedure or treatment usually entails a list of the most common complications, so that they can be foreseen, prevented or recognized more easily and speedily. Depending on the degree of vulnerability, susceptibility, age, health status, immune system condition, etc. complications may arise more easily. Complications affect adversely the prognosis of a disease. Non-invasive and minimally invasive medical procedures usually favor fewer complications in comparison to invasive ones. Examples of complications * Generalized septicemia (infection of the blood) may occur as a complication of an infected wound or abscess * Allergic shock can be a reaction to several kinds of anesthetics, as a complication in a surgery * Fractured ribs and sternum may be a complication of cardiopulmonary resuscitation attempts in people suffering severe osteoporosis * Puerperal fever may be a common complication of childbirth and used to kill a large proportion of mothers before the advent of antisepsis and antibiotics * Diabetes mellitus may present a series of complications in an advanced or more severe stage, such as gangrene, diabetic foot, blindness, infections, etc. * Thrombosis in the heart or brain, causing stroke or acute myocardial infarction can be complications of blood coagulation disorders, phlebitis (inflammation of the veins), endocarditis and artificial heart valves * Eczema vaccinatum is a rare and severe complication of smallpox vaccination in people with eczema * Hepatotoxic dementia is a possible complication of hepatitis and liver cirrhosis * Mental retardation is a common complication of untreated hydrocephalus * A paradoxical reaction to a drug; that is, a reaction that is the opposite to the intended purpose of the drug. An example is benzodiazepines, a class of psychoactive drugs considered minor tranquilizers with varying hypnotic, sedative, anxiolytic, anticonvulsant, and muscle relaxant effects; paradoxically they may also create hyperactivity, anxiety, convulsions etc. in susceptible individuals. [1] * Erectile dysfunction and urinary incontinence are prevalent to prostatectomy.

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

Complicaţie, în medicină, este o evoluţie nefavorabilă de o boală, o stare de sănătate sau de un tratament medical. Boala poate deveni mai rău în severitatea acesteia sau Arată un număr mai mare de semne, simptome sau noile modificări patologice, devenit larg răspândite pe tot corpul sau afecta alte sisteme de organe. Un tratament medical, cum ar fi medicamente sau o intervenţie chirurgicală pot produce efecte adverse sau produc noi sănătate problema (e) de la sine. O boală nouă, de asemenea, pot să apară ca o complicaţie a unei boli existente anterior. Prin urmare, o complicaţie poate fi iatrogenă, adică, literalmente Adus de către medic. Cunoştinţele medicale despre o boala, procedura sau un tratament implică, de obicei, o listă cu cele mai frecvente complicatii, astfel încât acestea pot fi prevazute, prevenite sau recunoscut mai uşor şi mai rapid. În funcţie de gradul de vulnerabilitate, sensibilitate, vârsta, starea de sănătate, sistemul imunitar condiţie, etc. complicaţii pot apărea mai uşor. Complicatiile afecteaza negativ prognosticul bolii o. Proceduri medicale non-invazive şi minim invazivă, de obicei, favoare mai puţine complicaţii în comparaţie cu cele de invazive. Exemple de complicaţii * generalizat septicemia (infecţie de sânge) pot să apară ca o complicaţie de rana infectate sau abces * şoc alergică poate fi o reacţie la mai multe tipuri de anestezice, ca o complicaţie într-o intervenţie chirurgicală * fracturat coaste şi sternului poate fi o complicaţie a încercările de Resuscitare cardiopulmonare la persoanele care suferă de osteoporoză gravă * febră puerperală poate fi o complicatie frecventa a naşterii şi utilizate pentru a ucide o proporţie mare de mame înainte de apariţia antisepsis şi antibiotice * diabet zaharat poate prezenta o serie de complicaţii într-un stadiu avansat sau mai severe, cum ar fi cangrena, picior diabetic, orbire, infecţii, etc. * Tromboză în inima sau creierul, determinand accident vascular cerebral sau infarct miocardic acut poate fi complicaţii de tulburări de coagulare sange, Flebită (inflamarea venelor), endocardita si valvele cardiace artificiale * eczeme vaccinatum este o complicaţie rară şi severe de variolă vaccinare la persoanele cu eczeme * hepatotoxice demenţă este o complicatie posibila a ficatului şi hepatita ciroza * retard Mental este o complicatie frecventa hidrocefaliei netratate * O reacţie paradoxală la un medicament; Asta este, o reacţie, care este opusul scopul de droguri. Un exemplu este benzodiazepine, o clasă de medicamente psihoactive considerat minor tranchilizante cu diferite hipnotic, sedativ, anxiolitic, anticonvulsivant şi musculare relaxant efecte; paradoxal acestea pot, de asemenea, crea hiperactivitate, anxietate, convulsii etc la persoanele sensibile. [1] * Sunt predominante la prostatectomia disfuncţie erectilă şi incontinenţă urinară.

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

A contraindication (pronounced as contra-indication) is a condition or factor that speaks against a certain measure. It is mostly used in medicine, with regard to factors that increase the risks involved in using a particular drug, carrying out a medical procedure, or engaging in a particular activity. Some contraindications are absolute, meaning that there are no reasonable circumstances for undertaking a course of action. For example, a baby with a fever should never be given aspirin because of the risk of Reye's syndrome, and a person with an anaphylactic food allergy should never eat the food to which they are allergic. Similarly, a person with hemochromatosis should not be administered iron preparations. Other contraindications are relative, meaning that the patient is at higher risk of complications, but that these risks may be outweighed by other considerations or mitigated by other measures. For example, a pregnant woman should normally avoid getting X-rays, but the risk may be far less than the risk of not diagnosing or being able to treat a serious condition such as tuberculosis or a broken bone. Relative contraindications may also be referred to as cautions, such as in the British National Formulary.

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

O contraindicaţie (pronunţat ca contra-indicaţie) este o condiţie sau factor de care vorbeşte împotriva unei anumite măsuri. Cea mai mare parte este utilizat în medicină, în ceea ce privește factorii care cresc riscurile implicate în folosind un anumit medicament, efectuarea unei proceduri medicale sau angajarea într-o anumită activitate. Unele contraindicaţii sunt absolut, ceea ce înseamnă că nu există nici un caz rezonabile pentru întreprindere un curs de acţiune. De exemplu, un copil cu o febră ar trebui să nu fi dat aspirina că riscul de sindromului Reye, şi o persoană cu o alergie alimentară anafilactice nu ar trebui să mănânce alimente la care sunt alergice. În mod similar, o persoană cu hemocromatoza ar trebui să fie administrat fier preparate. Alte contraindicatii sunt relative, ceea ce înseamnă că pacientul este un risc mai mare de complicaţii, dar că aceste riscuri pot fi compensate de alte considerente sau atenuate prin alte măsuri. De exemplu, o femeie gravidă în mod normal, ar trebui să evite obtinerea de raze x, dar riscul poate fi mult mai puţin decât riscul de a nu diagnosticarea sau de a fi capabil de a trata o condiţie grave, cum ar fi tuberculoza sau un os rupt. Contraindicatii relative poate de asemenea fi menţionată ca atenţionări, cum ar fi în formularul de aplicaţie Naţional britanic.

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

In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. The opposite of indication is contraindication.

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

In meidcina,o indicatie este un argument intemeiat pentru a utiliza un anumit test,medicament,procedura sau interventie chirurgicala.Opusul termenului "indicatie" este "contraindicatie".

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

"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 information needed to use it in safety and to identify the manufacturer, taking account of the training and knowledge of potential user. This information includes the details on label and the data in 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 on 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

Instrucţiuni de utilizare

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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