IEC 63077-ed.1.0

Podrobné informace

Označení: IEC 63077-ed.1.0

Datum vydání: 13.11.2019

Stran: 33

Země: Mezinárodní technická norma

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Anotace

IEC 63077:2019 describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration. The MEDICAL IMAGING EQUIPMENT and systems covered by this document include: – X-RAY EQUIPMENT; – X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES; – X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY; – MAGNETIC RESONANCE EQUIPMENT; – ULTRASONIC DIAGNOSTIC EQUIPMENT; – GAMMA CAMERAS; – PLANAR WHOLEBODY IMAGING EQUIPMENT; – equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT); – SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – POSITRON EMISSION TOMOGRAPHS (PET); – PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT: and – other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above. This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems. IEC 63077:2019 includes the following significant technical changes with respect to IEC PAS 63077:2016: a) the scope was delineated more clearly; b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added; c) smaller corrections were performed. LIEC 63077:2019 decrit et definit le PROCESSUS de RECONDITIONNEMENT des APPAREILS D’IMAGERIE MEDICALE USAGES et s’applique a redonner aux APPAREILS D’IMAGERIE MEDICALE USAGES une condition de securite et de performances comparable a celle d’un appareil neuf, c’est-a-dire un APPAREIL D’IMAGERIE MEDICALE qui n’a pas ete utilise. Cette restauration inclut des actions telles que la REPARATION, la RETOUCHE, les mises a jour logiciel/materiel ainsi que le remplacement des pieces usagees par des pieces d’origine. Le present document enumere les actions qui sont realisees en coherence avec les specifications et les procedures d’entretien applicables, exigees pour garantir que le RECONDITIONNEMENT d’un APPAREIL D’IMAGERIE MEDICALE est effectue sans modification des performances de l’APPAREIL D’IMAGERIE MEDICALE fini, des specifications de securite ni de l’UTILISATION PREVUE selon son enregistrement valide d’origine ou applicable. Les APPAREILS et systemes D’IMAGERIE MEDICALE couverts par le present document incluent les elements suivants: – APPAREILS A RAYONNEMENT X; – APPAREILS A RAYONNEMENT X pour INTERVENTIONS GUIDEES PAR RADIOSCOPIE; – APPAREILS A RAYONNEMENT X POUR TOMODENSITOMETRIE; – APPAREILS A RESONANCE MAGNETIQUE; – APPAREILS DE DIAGNOSTIC A ULTRASONS; – CAMERAS GAMMA; – EQUIPEMENTS D’IMAGERIE PLANAIRE DU CORPS ENTIER; – appareils pour TOMODENSITOMETRIE PAR EMISSION DE PHOTONS SIMPLES (SPECT); – systemes hybrides SPECT/CT, combinant une CAMERA GAMMA et un EQUIPEMENT A RAYONNEMENT X POUR TOMODENSITOMETRIE (CT); – TOMOGRAPHES A EMISSION DE POSITRONS (PET); – systemes hybrides SPECT/CT combinant un TOMOGRAPHE A EMISSION DE POSITRONS et un EQUIPEMENT A RAYONNEMENT X POUR TOMODENSITOMETRIE (CT); – systemes hybrides PET/MRI combinant un TOMOGRAPHE A EMISSION DE POSITRONS et un APPAREIL A RESONANCE MAGNETIQUE: et – autres combinaisons des APPAREILS ou systemes enumeres ci-dessus. Le present document ne s’applique pas aux appareils d’endoscopie, aux appareils pour fond d’oil, aux appareils de radiotherapie ni aux systemes associes. LIEC 63077:2019 inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) le domaine dapplication a ete defini plus precisement; b) une liste informative des references croisees du contenu de lIEC 63077 en regard de lISO 13485 a ete ajoutee (Annexe A); c) de petites corrections ont ete faites.