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DISPOSITIVO MEDICO [3 records]
Record 1 - internal organization data 2021-08-26
Record 1, English
Record 1, Subject field(s)
- Pharmacology
- Surgery
- Non-Surgical Treatment
- Symptoms (Medicine)
Record 1, Main entry term, English
- adverse event
1, record 1, English, adverse%20event
correct, standardized
Record 1, Abbreviations, English
Record 1, Synonyms, English
Record 1, Textual support, English
Record number: 1, Textual support number: 1 OBS
An adverse event occurs during or after a treatment, but is not necessarily caused by the treatment itself. 2, record 1, English, - adverse%20event
Record number: 1, Textual support number: 2 OBS
It may involve the exacerbation of a pre-existing condition, intercurrent diseases, an accident, a drug interaction or a significant worsening of the disease. 3, record 1, English, - adverse%20event
Record number: 1, Textual support number: 3 OBS
adverse event: designation standardized by the Health Technology Assessment (HTA) Glossary English Editorial Board and the Translation Bureau. 4, record 1, English, - adverse%20event
Record 1, French
Record 1, Domaine(s)
- Pharmacologie
- Chirurgie
- Traitements non chirurgicaux
- Symptômes (Médecine)
Record 1, Main entry term, French
- événement indésirable
1, record 1, French, %C3%A9v%C3%A9nement%20ind%C3%A9sirable
correct, masculine noun, standardized
Record 1, Abbreviations, French
Record 1, Synonyms, French
- évènement indésirable 2, record 1, French, %C3%A9v%C3%A8nement%20ind%C3%A9sirable
correct, masculine noun
Record 1, Textual support, French
Record number: 1, Textual support number: 1 OBS
Un événement indésirable survient pendant ou après un traitement, mais il n'est pas nécessairement causé par le traitement. 3, record 1, French, - %C3%A9v%C3%A9nement%20ind%C3%A9sirable
Record number: 1, Textual support number: 2 OBS
Il peut s'agir de l'exacerbation d'un problème préexistant, de maladies intercurrentes, d'un accident, d'une interaction médicamenteuse ou d'une aggravation importante de la maladie. 4, record 1, French, - %C3%A9v%C3%A9nement%20ind%C3%A9sirable
Record number: 1, Textual support number: 3 OBS
événement indésirable : désignation normalisée par l'Institut national d'excellence en santé et en services sociaux (INESSS) et le Bureau de la traduction. 2, record 1, French, - %C3%A9v%C3%A9nement%20ind%C3%A9sirable
Record 1, Spanish
Record 1, Campo(s) temático(s)
- Farmacología
- Cirugía
- Tratamiento sin cirugía
- Síntomas (Medicina)
Record 1, Main entry term, Spanish
- evento adverso
1, record 1, Spanish, evento%20adverso
correct, masculine noun
Record 1, Abbreviations, Spanish
- EA 2, record 1, Spanish, EA
correct, masculine noun
Record 1, Synonyms, Spanish
- acontecimiento adverso 3, record 1, Spanish, acontecimiento%20adverso
correct, masculine noun
Record 1, Textual support, Spanish
Record number: 1, Textual support number: 1 DEF
[...] suceso médico [indeseable] que puede presentarse durante el tratamiento con un medicamento[, dispositivo médico o producto sanitario, ] pero que no necesariamente tiene una relación causal con dicho tratamiento. 2, record 1, Spanish, - evento%20adverso
Record number: 1, Textual support number: 1 OBS
Las reacciones adversas y los eventos adversos no siempre son lo mismo. Un evento adverso es cualquier suceso indeseable experimentado por un paciente, independientemente de que se sospeche o no del medicamento administrado. Un ejemplo de un evento adverso es un paciente que sufre un accidente de tráfico mientras estaba con un tratamiento farmacológico específico. Mientras que una reacción adversa (RAM) es cualquier suceso indeseable que ha sucedido con el paciente mientras estaba utilizando un medicamento y existe la sospecha de que es causado por el medicamento. 4, record 1, Spanish, - evento%20adverso
Record 2 - internal organization data 2013-05-15
Record 2, English
Record 2, Subject field(s)
- Medical and Surgical Equipment
Record 2, Main entry term, English
- health care product
1, record 2, English, health%20care%20product
correct, standardized
Record 2, Abbreviations, English
Record 2, Synonyms, English
Record 2, Textual support, English
Record number: 2, Textual support number: 1 DEF
A medical device, including an in vitro diagnostic medical device, or a medicinal product, including a biopharmaceutical. 1, record 2, English, - health%20care%20product
Record number: 2, Textual support number: 1 OBS
health care product: term and definition standardized by the International Organization for Standardization (ISO). 2, record 2, English, - health%20care%20product
Record 2, Key term(s)
- healthcare product
Record 2, French
Record 2, Domaine(s)
- Équipement médico-chirurgical
Record 2, Main entry term, French
- produit de santé
1, record 2, French, produit%20de%20sant%C3%A9
correct, see observation, masculine noun, standardized
Record 2, Abbreviations, French
Record 2, Synonyms, French
Record 2, Textual support, French
Record number: 2, Textual support number: 1 DEF
Dispositif médical, notamment un dispositif médical de diagnostic in vitro, ou un produit médicinal, notamment un produit biopharmaceutique. 1, record 2, French, - produit%20de%20sant%C3%A9
Record number: 2, Textual support number: 1 OBS
produit de santé : terme et définition normalisés par l'Organisation internationale de normalisation (ISO). 2, record 2, French, - produit%20de%20sant%C3%A9
Record 2, Spanish
Record 2, Campo(s) temático(s)
- Equipo médico y quirúrgico
Record 2, Main entry term, Spanish
- producto sanitario para el cuidado de la salud
1, record 2, Spanish, producto%20sanitario%20para%20el%20cuidado%20de%20la%20salud
correct, masculine noun
Record 2, Abbreviations, Spanish
Record 2, Synonyms, Spanish
Record 2, Textual support, Spanish
Record number: 2, Textual support number: 1 DEF
Dispositivo médico, producto medicinal(farmacéutico o biológico) o dispositivo de diagnóstico médico in vitro. 1, record 2, Spanish, - producto%20sanitario%20para%20el%20cuidado%20de%20la%20salud
Record 3 - internal organization data 2007-11-26
Record 3, English
Record 3, Subject field(s)
- Marketing
- Prostheses
- Medication
Record 3, Main entry term, English
- premarket approval
1, record 3, English, premarket%20approval
correct
Record 3, Abbreviations, English
- PMA 1, record 3, English, PMA
correct
Record 3, Synonyms, English
Record 3, Textual support, English
Record number: 3, Textual support number: 1 CONT
Pre-market approval (PMA) permits an applicant to market a particular medical device. PMA requirements apply to Class III devices. PMA requirements differ between preamendment and postamendment devices. 2, record 3, English, - premarket%20approval
Record 3, French
Record 3, Domaine(s)
- Commercialisation
- Prothèses
- Médicaments
Record 3, Main entry term, French
- approbation préalable à la mise en marché
1, record 3, French, approbation%20pr%C3%A9alable%20%C3%A0%20la%20mise%20en%20march%C3%A9
correct, feminine noun
Record 3, Abbreviations, French
Record 3, Synonyms, French
- autorisation préalable à la mise en marché 3, record 3, French, autorisation%20pr%C3%A9alable%20%C3%A0%20la%20mise%20en%20march%C3%A9
correct, feminine noun
Record 3, Textual support, French
Record number: 3, Textual support number: 1 CONT
L'approbation préalable à la mise en marché permet à un requérant de commercialiser un dispositif médical particulier. 1, record 3, French, - approbation%20pr%C3%A9alable%20%C3%A0%20la%20mise%20en%20march%C3%A9
Record 3, Spanish
Record 3, Campo(s) temático(s)
- Comercialización
- Prótesis
- Medicamentos
Record 3, Main entry term, Spanish
- aprobación de precomercialización
1, record 3, Spanish, aprobaci%C3%B3n%20de%20precomercializaci%C3%B3n
correct, feminine noun
Record 3, Abbreviations, Spanish
Record 3, Synonyms, Spanish
- autorización para la precomercialización 2, record 3, Spanish, autorizaci%C3%B3n%20para%20la%20precomercializaci%C3%B3n
correct, feminine noun
Record 3, Textual support, Spanish
Record number: 3, Textual support number: 1 CONT
Es posible que la autoridad reguladora local exija para la comercialización del DM(dispositivo médico) : Notificación de conformidad precomercialización; Aprobación de precomercialización; Sin requisitos de precomercialización. 1, record 3, Spanish, - aprobaci%C3%B3n%20de%20precomercializaci%C3%B3n
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