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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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list of symbols used on the package/label and their explanation

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

elenco di simboli utilizzati sulla confezione/etichetta e loro spiegazione

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

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

Intracorneal Ring impianti (INTACS) sono un'opzione di correzione di visione per trattare bassi a livelli moderati di miopia. INTACS vengono utilizzati per correggere la miopia in pazienti che hanno il cheratocono e coloro che hanno miopia residua dopo laser refrattiva o chirurgia LASIK.

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

list of symbols used on the package/label and their explanation

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

elenco di simboli utilizzati sulla confezione/etichetta e loro spiegazione

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 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 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 medicina, l'indicazione è un valido motivo per usare una certa prova, farmaco, procedura o chirurgia. Controindicazione è il contrario dell'indicazione.

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

Secondo gli standard di sicurezza negli Stati Uniti, le dichiarazioni di precauzione sono frasi che forniscono informazioni su potenziali rischi e su procedure appropriate. Sono utilizzate in contesti che variano da etichette e manuali, a descrizioni di attività fisiche. Vengono utilizzati vari metodi per metterle in evidenza, ad esempio separandole dal testo normale, utilizzando icone grafiche o caratteri e colori differenti. I messaggi spesso chiarificano le affermazioni ed i contenuti del testo. Le dichiarazioni di precauzione più comuni sono descritte di seguito.

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: 

Con dose si indica una quantità nei seguenti campi: In nutrizione, medicina e tossicologia: * Dose (biochimica), la quantità di qualcosa che può essere mangiato da o somministrato ad un organismo, o a cui un organismo può essere esposto In medicina e tossicologia: * Dose assorbita, quantità di radiazione ricevuta * Dosaggio, processo di somministrazione di una quantità misurata di una medicina o di un agente chimico ad un oggetto inanimato o ad un animale non umano * Dose effettiva, la quantità minima di una sostanza necessaria per produrre un effetto misurabile su un organismo vivente * Dose equivalente, una misura del dosaggio di radiazioni dirette al tessuto * Dose massima tollerata, la dose maggiore di un trattamento radiante o farmacologico che produce l'effetto desiderato senza tossicità inaccettabile. * Dose Biologica Ottimale, la quantità di un trattamento radiante o farmacologico che produce l'effetto desiderato con tossicità accettabile. * Dose di riferimenti, la massima dose orale di una sostanza tossica accettabile secondo la United States Environmental Protection Agency Dosaggio è un sinonimo del termine biochimico dose!

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

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: 

In medicina, un evento avverso è un effetto dannoso ed inatteso dovuto ad un farmaco o ad altri interventi, come ad esempio la chirurgia. Un evento avverso può definirsi un \"effetto collaterale\" quando si ritiene secondario all'effetto principale o terapeutico, e può risultare da una dose o procedura non idonea o errata, presumibilmente dovuta ad un errore medico. Gli eventi avversi sono a volte definiti \"iatrogeni\" perché sono causati da un medico/trattamento. Alcuni eventi avversi si verificano solo quando si inizia, aumenta o interrompe un trattamento. Utilizzando un farmaco o altri interventi medici controindicati si può aumentare il rischio di eventi avversi. Gli eventi avversi possono causare complicazioni mediche di una patologia o procedura influendo negativamente sulla prognosi. Possono anche impedire la corretta aderenza al regime di trattamento. L'effetto nocivo è generalmente evidenziato tramite alcuni fattori quali morbidità, mortalità, alterazioni del peso corporeo, livelli enzimatici, perdita di funzionalità, oppure tramite cambiamenti patologici determinati a livello microscopico, macroscopico o fisiologico. Può anche essere messo in evidenza dai sintomi riferiti dal paziente. Eventi avversi possono causare cambiamenti reversibili o irreversibili, come l'aumento o la diminuzione nella suscettibilità dell'individuo ad altri agenti chimici, cibi o procedure, come l'interazione tra farmaci. Negli studi clinici gli eventi avversi (AEs) sono distinti dagli eventi avversi seri (SAEs). Generalmente, un evento che causa morte, danno permanente, difetti di nascita, o che richiede il ricovero in ospedale, è considerato un SAE.[1] I risultati di questi studi sono spesso inclusi nei foglietti informativi del farmaco per informare sia i pazienti sia i medici che lo prescrivono.

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: 

complicazioni che possono insorgere a seguito di intervento chirurgico

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: 

complicanze intraoperatorie, sono complicazioni, problemi nell'ambito dell'operazione, problemi intraoperatorie.

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

Una complicazione, in medicina, è un evoluzione sfavorevole di una malattia, di uno stato di salute o di un trattamento medico. La malattia può peggiorare nella sua gravità o mostrare un numero maggiore di segni, sintomi o modificarsi, diffondersi nell'organismo o intaccare altri organi. Un trattamento medico, come i farmaci o la chirurgia, possono di per sé produrre eventi avversi e/o nuovi problemi di salute. Una nuova malattia può anche insorgere come complicazione ad una patologia preesistente. Perciò, una complicazione può essere iatrogena, cioè letteralmente generata dal medico. La conoscenza medica di una malattia, una procedura o un trattamento, generalmente include una lista di complicazioni molto comuni, in modo che queste possano essere previste, prevenute o riconosciute più facilmente e velocemente. In base a grado di vulnerabilità, suscettibilità, età, stato di salute, condizioni del sistema immunitario, etc., le complicazioni possono insorgere più o meno facilmente. Le complicazioni influiscono negativamente sulla prognosi di una malattia. Le procedure mediche non invasive o minimamente invasive di solito comportano meno complicazioni rispetto alle procedure invasive. Esempi di complicazioni * La sepsi generalizzata (infezione del sangue) può insorgere come complicazione dell'infezione di una ferita o un ascesso * Lo shock allergico può essere una reazione a diversi tipi di anestetici come complicazione in chirurgia * Costole e sterno fratturati possono essere una complicazione di un tentativo di rianimazione cardiopolmonare in pazienti affetti da osteoporosi * La febbre puerperale può essere una complicazione molto comune del parto ed era solita uccidere molte madri prima dell'avvento di antisettici ed antibiotici * Il diabete mellito può avere una serie di complicazioni in condizioni avanzate o gravi, come ad esempio gangrena,piede del diabetico, cecità, infezioni, etc. * Le trombosi cardiaca o cerebrale, che causano ictus o infarto acuto del miocardio rispettivamente, possono essere complicazioni legate a disordini della coagulazione del sangue, fleibiti (infiammazioni delle vene), endocarditi e valvole cardiache artificiali * L'eczema da vaccinazione è una complicazione rara e severa del vaccino contro il vaiolo in soggetti con eczema * Il ritardo mentale è una complicazione molto comune dell'idrocefalo non trattato * Una reazione paradossale ad un farmaco; cioè, una reazione che è opposta all'effetto desiderato del farmaco. Un esempio è rappresentato dalle benzodiazepine, una classe di farmaci psicoattivi considerati tranquillanti minori e aventi effetti ipnotici, sedativi, ansiolitici, anticonvulsivi e miorilassanti variabili; in alcuni individui, paradossalmente, possono anche indurre iperattività, ansia, convulsioni etc. [1] * Disfunzione erettile e incontinenza urinaria sono prevalenti dopo una prostectomia.

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

Una controindicazione (pronunciato contro-indicazione) è una condizione o un fattore contrario ad una certa misura. E' un termine utilizzato per lo più in medicina, e si riferisce a fattori che aumentano i rischi connessi all'uso di un determinato medicinale, ad una procedura medica o allo svolgimento di una particolare attività. Alcune controindicazioni sono assolute, nel senso che non ci sono circostanze ragionevoli per intraprendere quella determinata azione. Ad esempio, ad un bambino con la febbre non si dovrebbe mai somministrare aspirina a causa del rischio di insorgenza della sindrome di Reye, mentre una persona con un'allergia ad un cibo non dovrebbe mai ingerire il cibo a cui è allergica. Allo stesso modo, persone affette da emocromatosi non dovrebbero mai assumere preparazioni a base di ferro. Altre controindicazioni sono relative, nel senso che il paziente è a rischio di complicazioni, ma tale rischio può essere controbilanciato da altre considerazioni o ridotto da altre misure. Ad esempio, una donna incinta dovrebbe generalmente evitare i raggi X, ma il rischio può essere molto minore di quello connesso ad una mancata diagnosi o alla possibilità di trattare una condizione più seria come la tubercolosi o una frattura ossea. Controindicazioni relative possono anche essere definite precauzioni, come riportato nel Formulario Nazionale Britannico.

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

confezione also: presentazione

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

lente intraoculare (IOL) Una volta asportato il cristallino catarattoso sarà necessario impiantare un cosiddetto cristallino artificiale o IOL. Tale cristallino non ha però le caratteristiche di quello naturale di poter cambiare il suo spessore permettendo quindi sia la visione del lontano che del vicino, ma soltanto di una delle due distanze. Per tale motivo nella maggioranza dei casi esso si calcola per poter svolgere la vita di relazione e cioè per la lontananza; per la lettura saranno necessarie delle lenti ausiliarie (lenti da presbiopia). Il calcolo della “gradazione” del cristallino viene fatto con uno strumento chiamato ECOBIOMETRO contestualmente alla visita specialistica. Tale apparecchio permette di misurare, grazie agli ultrasuoni, la lunghezza dell’occhio e quindi stabilire la “potenza” del cristallino da impiantare.

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

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

Descrizione una dichiarazione che presenta qualcosa in parole, dal verbo descrivere

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 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

"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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