Direttiva 93 42 cee pdf free

Stretchers new rollable medical device designed for rescue in confined. Tutte le lenti grossoptic sono conformi ai requisiti della direttiva europea 9342 cee. Direttiva del consiglio del 21 dicembre 1989 concernente il ravvicinamento delle legislazioni degli stati membri relative ai dispositivi di protezione individuale 89686 cee avvertenza. Medical device complying with european directive 93 42 cee iia class, designed and manufactured according to the iso9001, iso485, fu it xi ed. This product conforms to medical device guideline 9342ewg. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise the laws relating to medical devices within the european union.

Essential requirements annex i, 9342eec as compliance. Conforme alla direttiva 9342cee relativa ai prodotti medicali. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Whit vinyl powder free non sterile e free 0465 en 374 en 374 gkl en 388 c max 50 c min. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device on the european market the requirements of the md. Ha ving regard to the 9342eec directive concerning medical devices. The content of this page deals only with the medical devices directive 93 42 eec. Some of these cookies are essential to the operation of the site, while others help to improve your experience by providing insights into how the site is.

Direttiva 93 42 cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici gazzetta ufficiale n. Dpi ill categoria dm di i classe guanto di protezione contro agenti chimici e micro organismi. Direttiva 200332ce direttiva 200332ce della commissione, del 23 aprile 2003, recante modalita specifiche relative ai requisiti previsti dalla direttiva 9342cee per i dispositivi medici fabbricati con tessuti dorigine animale gu l 105 del 26. This document is in italian only and downloadable from. Direttiva del consiglio del 21 dicembre 1989 concernente il ravvicinamento delle legislazioni degli stati membri relative ai dispositivi di protezione individuale 89686cee avvertenza. Conformity with medical device directive 9342 eec is mandatory all devices that fit the definition of a and its accessories this directive is of the regulation remains pending. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169. Martellago ve, declares on its own responsibility that itech mag is manufactured in conformity with directive 9342eec mdd, dated 14 june 1993 d. Cpe cast of polyethylene powder free non sterile embossed ambidextrous transparent white colour available in three sizes personal protection device of i category medical device of i class protection glove, in conformity with directive ecc89686. Instructions for use and fluid control system operators. There are three medical device directives in place, the directive of active implantable medical devices 90385eec, the medical devices directive 9342eec, and the directive of in vitro diagnostic medical devices 9879ec. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to. Cee translation into english examples italian reverso.

A010102 manufacturer, classification and intended use producer and production place. Questions relating to the implementation of directive 200747 ec 1. All grossoptic ophthalmic lenses are in compliance with the requirements of european directive 9342 eec. Directive 200070ec of the european parliament and of the council of 16 november 2000. For a device to be classified as an active implant, it must rely on a power source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products covered by them. Ha ving regard to the 93 42 eec directive concerning medical devices. Direttiva 90496 cee del consiglio, del 24 settembre 1990, relativa alletichettatura nutrizionale dei prodotti alimentari. Misurare il paziente stesso metodo di regolazione per. Tutte le lenti grossoptic sono conformi ai requisiti della direttiva europea 93 42 cee.

Pdf habitat e specie della direttiva 9243cee ed altri. Italiano istruzioni per luso allineare il capo nella posizione neutra o occhi in avanti, salvo controindicazioni in base al protocollo in uso. B council directive 2006112ec of 28 november 2006 on. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169. B council directive 9342eec of 14 june 1993 concerning. The social cost of the large number of accidents caused by the use of machinery can be reduced by. The new machinery directive has been applicable since 29th leggi tutto. Direttiva 89686 sui dispositivi di protezione individuale. I materiali sono di grado medicale e i componenti sono conformi a iso 59412, f. Cee translation english italian dictionary reverso. Council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices oj no l 189 of 20 july 1990. The references published under directive 93 42 eec on medical devices are found in commission implementing decision eu 2020437 of 24 march 2020 oj l 90i, 25 march 2020 listed below.

Stesso metodo di misurazione sia per il select che per il pediselect. Implementing directive 90496eec 21 the ministry of agriculture, fisheries and food maff. Free of rigid frames and easily storable and transportable. Pdf on jan 1, 2006, venanzoni roberto and others published habitat e specie della direttiva 9243cee ed altri aspetti di rilevanza naturalistica al lago trasimeno. It was commissioned by ec directorategeneral for internal market, industry, entrepreneurship and smes dg grow, and undertaken by a consortium led by technopolis group over an 18month period during 20162017. Overview a medical device is defined in directive 93 42 eec as.

The light chair complies with medical devices directive 9342eec altezza minima. Class i device confezionamento packaging confezione primaria primary packaging 260ml in flacone di pe atossico, richiudibile 260ml in pe nontoxic bottle, open close cap confezione di vendita sale packaging 35 flaconi in scatola di cartone 35 bottles in carton box. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Cochlear wireless phone clip user manual pdf download. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Composition des materiaux lycra, mtp5 40, jersey 28% polyamide. They areconsidered the state of the art, and are considered not mandatory but in reality you will be unable to cemark a device without the use of harmonized eu standards.

Dispositivi medici detraibili nella dichiarazione dei. Medical devices internal market, industry, entrepreneurship. Direttiva 9342cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici gazzetta ufficiale n. All grossoptic ophthalmic lenses are in compliance with the requirements of european directive 93 42 eec. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993.

Lo stato dellarte delle poltrone dentali stateoftheart. There are three medical device directives in place, the directive of active implantable medical devices 90385eec, the medical devices directive 93 42 eec, and the directive of in vitro diagnostic medical devices 9879ec. Compliance of medical devices with the new requirements according to article 2 of directive 9342eec, member states shall take all necessary steps to ensure that devices may be placed on the market andor put into service only if. The active implantable medical devices directive with the official reference number 90385eec applies only to active implantable devices. Conformity with the machinery directive became mandatory on january 1, 1995 and covers new and used machinery being placed on the market for the first time. Medical device complying with european directive 9342cee iia class, designed and manufactured according to the iso9001, iso485, fu it xi ed. I, the undersigned, hereby declare that the equipment specified herein conforms with the applicable provisions of ec directive 93 42 eec concerning medical devices. Direttiva 90496cee del consiglio, del 24 settembre 1990, relativa alletichettatura nutrizionale dei prodotti alimentari. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. Contents 1 x mask 1 x instructions for use 1 x brochure. The product must be used exclusively on intact skin and free of ecchymoses or wounds. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7.

Directive 93 42 cee du conseil, du 14 juin 1993, relative aux dispositifs medicaux. Machinery directive 9837ec cemarking what manufacturers. Active implantable medical devices directive 90385eec. Exclusion of liability hologic is not liable for direct or consequential damage and the warranty is null and void if. Active implantable medical devices internal market. Council directive 9342eec of 14 june 1993 concerning medical devices.