TERMIUM Plus®

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HCPS [1 record]

Filter results by subject field Alphabetical list of terms

Filter results by subject field

Alphabetical list of terms

Record 1 2025-10-08

English

Subject field(s)
  • Medical Instruments and Devices
  • Prostheses
DEF

... a medical device, other than a mass-produced medical device, that(a) is manufactured in accordance with a HCP's [health care professional' s] written direction giving its design characteristics;(b) differs from medical devices generally available for sale or from a dispenser; and(c) is for the sole use of a particular patient of that professional, or, is for use by that professional to meet special needs arising in the course of his or her practice.

OBS

Mass-produced devices that need to be adapted to meet the specific requirements of the medical practitioner are not considered to be custom-made devices.

OBS

custom-made device: designation standardized by ISO.

French

Domaine(s)
  • Instruments et appareillages médicaux
  • Prothèses
DEF

[...] instrument médical - non fabriqué en série - qui : a) est fabriqué selon les directives écrites d'un professionnel de la santé précisant ses caractéristiques de conception; b) s'écarte des instruments médicaux qui généralement se trouvent dans le commerce ou peuvent être obtenus d'un préparateur; c) est destiné soit à l'usage exclusif d'un patient donné du professionnel, soit à l'usage du professionnel afin de répondre à des besoins spéciaux dans l'exercice de sa profession.

OBS

Les dispositifs produits en série devant être adaptés pour convenir aux besoins spécifiques du médecin ne sont pas considérés comme des dispositifs sur mesure.

OBS

dispositif sur mesure : désignation normalisée par l'ISO.

Spanish

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