CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

Directives As a first step, you need to verify whether your product(s) fall(s) within the definition of a medical device in accordance with Article 1 paragraph 2a) of Directive 93/42/EEC. Second, you need to exclude that your product(s) falls within the definition of an active implantable medical device (Directive 90/385/EEC) or of an in vitro diagnostic medical device (Directive 98/79/EC). Finally, you must verify that no other exclusion clause contained in the first Article of Directive 93/42/EEC is applicable. If all these conditions are fulfilled, Directive 93/42/EEC applies. • Download Directive 93/42/EEC on Medical devices (MDD) • For further information on Directive 93/42/EEC on Medical devices (MDD), please visit the DG SANCO webpage dedicated to this sector by following this link: http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm Verify requirements The New Approach Directives for the CE marking have been designed by the European Uni...

Luca Martinelli The self-aspirating dental syringe Publication no. 3 - 31st October 2012 1. THE SELF-ASPIRATING SYRINGE The self-aspirating syringe is so called because the aspiration takes place "automatically", without any need for retracting the plunger. There are at least two types of self-aspirating syringes, a standard and a "disk" model. 1.1 Standard self-aspirating syringe   Pic. 1 1.2 Disk self-aspirating syringe The structure is identical to the previous one, with the difference that the disk is integral with the vial-holder cylinder, but completely independent with respect of the plunger (It has a through hole that allows the plunger to slide inside it).   Example of a type of self-aspirating syringe with disk. Pic. 2 1.3 Loading The loading is substantially identical to the side-loading syringes except that the vial holder cylinder is to be retracted in order to have the space necessary to insert th...

Luca Martinelli Come vedere tutti i dispositivi medici, fabbricanti e mandatari registrati al Ministero della salute Molto spesso ci troviamo in difficoltà nell’individuare un dispositivo medico, in particolar modo individuarne il suo numero progressivo di registrazione presso la banca dati del Ministero , il numero di CND ( Classificazione Nazionale Dispositivi medic i ) e per coloro che hanno eseguito la registrazione volontaria al RDM ( Repertorio dispositivimedici ) il numero dì RDM, a volte serve anche individuarne la classe di rischio di appartenenza. Per ottenere tutti questi dati non è necessario rivolgersi esclusivamente al fabbricante, che spesso per un infinità di ragioni non è in grado di fornire in tempo reale le informazioni, basta infatti collegarsi al sito del Ministero della Salute e verificare on line tutte le informazioni relative al dispositivo di interesse. Un data base ad hoc, con aggiornamento settimanale, permette infatti di fare una ricerca per ...

Aggiornamento al 11 Luglio 2014 LINK> AVVISI SITO MINISTERO SALUTE

Aggiornamento al 14 Luglio 2014 LINK> AVVISI SITO MINISTERO SALUTE

Prorogate fino al 30 Settembre le iscrizioni al corso per Addetto Assistente Dentista di Lucca

Accessory means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device; Active implantable medical device means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure; Active medical device Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is conside...