Transcription of Single-Use Medical Devices Reuse and Reprocessing
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Single-Use Medical Devices Reuse and Reprocessing
Single-Use Medical Devices Reuse and Reprocessing (Reference number 168862)Presented by: Mario CastanedaPrepared by: Antonio HernandezInternational Conference Center (CICG) Geneva, Switzerland. November 22-24, 2013. ghtf * - Harmonized Definition of the Term Medical Device Medical Device ' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of Medical Devices , providing information for Medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; andb) which does not achieve its primary intended action in or on the human body by pharmacological, immunolog
GHTF - Harmonized Definition of the Term “Medical Device” Note 1: The definition of a device for in vitro examination includes, for example, reagents, calibrators, sample collection and storage devices, control materials, and related instruments or
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