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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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elenco di simboli utilizzati sulla confezione/etichetta e loro spiegazione

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

sarakstu, simboli, ko izmanto iepakojuma/etiķetes un to skaidrojums

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

elenco di simboli utilizzati sulla confezione/etichetta e loro spiegazione

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

sarakstu, simboli, ko izmanto iepakojuma/etiķetes un to skaidrojums

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

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; Categoria: 

Amerikas Savienoto valstu drošības standartiem, piesardzības paziņojumiem ir teikumi, kas sniedz informāciju par iespējamo apdraudējumu un atbilstošas procedūras. Tie tiek izmantoti situācijās no patēriņa preču etiķetēs un pamācības, fizisko aktivitāšu aprakstiem. Dažādās metodes tiek izmantotas, lai fokusu, piemēram, nosakot neatkarīgi no parasta teksta, grafikas ikonas, teksta fontu un krāsu izmaiņas. Teksti bieži vien precizēs paziņojumiem un to nozīmes teksta veidu. Kopējā piesardzības paziņojumiem ir aprakstīti zemāk.

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

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; Categoria: 

Devas ir daudzums, kas šādās jomās: uzturs, medicīnā un toksikoloģija: * devas (bioķīmija) daudzums, kaut kas var ēst vai ievada organisma vai ja organisms var tikt pakļauti medicīnā un toksikoloģija: * absorbētās devas, iemaksājot saņemto starojuma * Dosing procesu administrēšanu mērījumu apjoms medikamenti vai ķimikālijas, nedzīvs objekts vai cilvēkiem nesaistīto dzīvniekiem * efektīvās devas, mazākais daudzums nepieciešams, lai saražotu izmērāmu iespaidu uz dzīvā organisma vielas * ekvivalento devu, audu radiācijas devas mērvienība * maksimāli pieļaujama devu, radiācijas vai farmakoloģisko ārstēšanu, kas ražos vēlamo efektu bez nepieņemami toksicitātes lielākajai devai. * Optimālu bioloģisko devu, daudzumu, radiācijas vai farmakoloģisko ārstēšanu, kas ražos vēlamo efektu ar pieņemamu toksicitāti. * Standartdevu, Amerikas Savienoto valstu vides aizsardzības aģentūra maksimālo pieņemamo perorālas devas toksiskas vielas devu, kas ir sinonīms bioķīmisko termins devu!

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

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; Categoria: 

Medicīnā, lielākā daļa zāles var droši lietot ar citām zālēm, bet konkrētu zāļu kombinācijas, stingri jāuzrauga mijiedarbību, bieži vien ar farmaceitu. Molekulārās bioloģijas zināšanas par gēnu/proteīnu mijiedarbība savā starpā un ar to metabolītu dēvē par molekulāro ceļus. Mijiedarbība starp medikamentiem (narkotiku mijiedarbība) parasti iedalās vienai no divām galvenajām kategorijām: 1. farmakodinamiskās: saistībā ar darbībām, kas mijiedarbojas divas narkotikas. 2. farmakokinētiskie: iesaistot absorbcijas, sadalījumu, metabolismu un ekskrēcija vienas vai abu mijiedarbojošās narkotikas uz otra. Attiecībā uz efektivitāti, var būt trīs veidu mijiedarbība starp medikamentiem: piedevas, sinerģisku un vēl sliktākas. Piedevu mijiedarbība nozīmē divu ķīmisko vielu iedarbība ir vienāda ar summu, efekta divas ķīmiskās vielas, kas ņemti atsevišķi. Parasti to izraisa divas ķīmiskās vielas, kas iedarbojas uz ķermeni, tādā pašā veidā. Piemēri būtu aspirīnu un Motrin, alkoholu un Depressant, trankvilizatoru un pretsāpju līdzeklis. Sinerģētisko mijiedarbību nozīmē kopā divas ķimikālijas iedarbība ir lielāka nekā summa pēc to atsevišķas ietekmes pašas devas. Piemērs ir pesticīdu un minerālmēslu, bioloģiskā iedarbība ir postoša. Antagonistisks mijiedarbība nozīmē, ka divu ķīmisko vielu iedarbība ir faktiski mazāks par summu, kas veikti neatkarīgi vienu no otras divas narkotikas iedarbību. Tas ir tāpēc, ka otrais ķīmiskā palielina izdalīšanos no pirmajiem vai pat tieši bloķē tās toksiskās darbības. Antagonisms veido pamatu pretindes saindēšanās.

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

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; Categoria: 

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; Categoria: 

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; Categoria: Biomedical; Diseases; Hospitals; Diseases; Herbal medicine; Medicine; Clinical trials; Implants & interventional materials

Sarežģījums, medicīna, ir nelabvēlīga attīstība, slimības, veselības stāvokli vai ārstēšanu. Slimības var kļūt sliktāka tā smagums vai parādīt lielāku skaitu pazīmes, simptomi vai jaunu patoloģiskās izmaiņas kļūst plaši izplatīta visā ķermenī vai ietekmēt citām orgānu sistēmām. Ārstēšana, piemēram, narkotiku vai ķirurģija var kaitīgu iedarbību un/vai radīt jaunu veselības problēmas (u) pati par sevi. Jaunas slimības var parādīties arī kā iepriekšējā esošās slimības komplikācija. Tādēļ sarežģījumi varētu būt jatrogēnu, t.i., burtiski izņēma ar ārsta. Medicīniskās zināšanas par slimību, procedūru vai ārstēšana parasti saistīts saraksts Visbiežākās komplikācijas, tāpēc, ka viņi var paredzēt, novērst vai atzītas viegli un ātri. Atkarībā no pakāpes ievainojamību, uzņēmību, vecumu, veselības stāvokli, imūnās sistēmas stāvokli, u.c. komplikācijas var rasties daudz vienkāršāk. Komplikācijas nelabvēlīgi ietekmē slimības prognoze. Non invazīvās un minimāli invazīvās medicīniskās procedūras parasti favor mazāk salīdzinājumā ar invazīvām tiem komplikācijas. Piemēri komplikācijas * Generalized septicemia (asins infekcijas) var rasties kā komplikācijas no inficētas brūces vai abscess * alerģija šoks var būt reakcija uz dažāda veida anestēzijas, kā komplikācija ķirurģijā * komplikācija no cilvēkiem, kas cieš smagas osteoporozes cardiopulmonary atdzīvināšana mēģinājumiem var Fractured ribas un krūšu * Puerperal drudzis var būt kopējas komplikācija bērna piedzimšanas un izmantot, lai nogalinātu lielu daļu no mātēm pirms advent antisepsis un antibiotiku * Diabetes diabēts var radīt virkni sarežģījumu papildu vai daudz nopietnākus posmā, piemēram, gangrēna, diabēta pēdas, aklumu, infekcijas, utt. * Tromboze sirdi vai smadzenes, izraisot insulta vai akūts miokarda infarkts var būt komplikācijas, flebīts (vēnu iekaisums) asins recēšanas traucējumi, endokardīts, mākslīgā sirds vārstuļi * ekzēma vaccinatum ir reti un smagas komplikācijas Baku vakcinācijas cilvēkiem ar ekzēmu * hepatotoksiska demenci ir iespējams sarežģījums hepatīts un aknu ciroze * garīga atpalicība ir kopējā neapstrādātā hidrocefālija komplikācija * paradoksālas reakcijas ar narkotikām; t.i., reakcija, kas ir pretēja paredzētajam narkotikas. Ir, piemēram, benzodiazepīni, klases psihoaktīvās narkotikas uzskata par nelielu trankvilizatori ar dažādu hipnotisks, sedatīvs, anxiolytic, anticonvulsant un muskuļu relaxant iedarbību; paradoksālā kārtā tie var arī radīt hiperaktivitāte, trauksme, konvulsijas uc uzņēmīgiem indivīdiem. [1] * Erekcijas disfunkcija un urīna nesaturēšana ir izplatītas prostatectomy.

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

Kontrindikāciju (izrunā kā contra norāde) ir nosacījums vai faktors, kas runā pret noteiktu pasākumu. To galvenokārt lieto zāles, attiecībā uz faktoriem, kas palielina risku, izmantojot īpaši narkotiku, medicīniskās procedūras veikšanu vai iesaistīties konkrētu darbību. Dažas kontrindikācijas ir absolūtā nozīmē, ka nav nekādu pamatotu apstākļu uzņēmums rīcības gaitu. Piemēram, bērns ar drudzi nekad nav jādod aspirīnu Reye sindromu riska dēļ, un persona ar Anafilaktiskas pārtikas alerģija nekad vajadzētu ēst pārtiku, ar kuru tie ir alerģija. Līdzīgi, hemochromatosis personai nevajadzētu būt regulējamo dzelzs preparātus. Citi kontrindikācijas ir relatīvas, nozīmē, ka pacients ir lielāks komplikāciju risks, bet šie riski var atsver citi apsvērumi vai mazināti ar citiem pasākumiem. Piemēram, grūtniecei parasti vajadzētu izvairīties kļūst rentgena starus, bet risks var būt daudz mazāk nekā nav diagnozi vai to var ārstēt nopietna stāvokļa, piemēram, tuberkulozi vai kaula lūzumu risku. Relatīvās kontrindikācijas var tikt dēvēta arī piesardzības pasākumus, piemēram, Lielbritānijas valsts formulārs.

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

Medicīnā, norāde ir pamatots iemesls izmantot dažu testu, medikamenti, procedūru vai ķirurģija. Kontrindikāciju ir norādi pretēja.

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

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

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

aprakstīt apraksts paziņojums rada kaut ko verb sabrukumam

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