Direttiva 93 42 cee pdf free

Direttiva 9342cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici gazzetta ufficiale n. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169, 12. Cee translation english italian dictionary reverso. 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. 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. 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. Active implantable medical devices internal market. Medical device complying with european directive 93 42 cee iia class, designed and manufactured according to the iso9001, iso485, fu it xi ed. B council directive 2006112ec of 28 november 2006 on.

Cochlear wireless phone clip user manual pdf download. 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. Direttiva 90496cee del consiglio, del 24 settembre 1990, relativa alletichettatura nutrizionale dei prodotti alimentari. The new machinery directive has been applicable since 29th leggi tutto. Free of rigid frames and easily storable and transportable. The light chair complies with medical devices directive 9342eec altezza minima. Federal law restricts this device to sale by or on the order of a physician. 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. Tutte le lenti grossoptic sono conformi ai requisiti della direttiva europea 9342 cee. Evaluation of directive 200642ec on machinery certifico srl. Stretchers new rollable medical device designed for rescue in confined. Contents 1 x mask 1 x instructions for use 1 x brochure.

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. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. The active implantable medical devices directive with the official reference number 90385eec applies only to active implantable devices. Ha ving regard to the 93 42 eec directive concerning medical devices. Direttiva 89686 sui dispositivi di protezione individuale. Stesso metodo di misurazione sia per il select che per il pediselect. Machinery directive 9837ec cemarking what manufacturers. Conforme alla direttiva 9342cee relativa ai prodotti medicali. 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. Understanding the machinery directive 2006 42ec the directive has been put in place because. 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. Active implantable medical devices directive 90385eec.

B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169. Misurare il paziente stesso metodo di regolazione per. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. The content of this page deals only with the medical devices directive 93 42 eec. 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. Overview a medical device is defined in directive 93 42 eec as. 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. Direttiva del consiglio del 21 dicembre 1989 concernente il ravvicinamento delle legislazioni degli stati membri relative ai dispositivi di protezione individuale 89686 cee avvertenza. Directive 75319eec council directive 75319eec of 20 may 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products oj no l 147 of 9. Exclusion of liability hologic is not liable for direct or consequential damage and the warranty is null and void if. Ha ving regard to the 9342eec directive concerning medical devices. Tutte le lenti grossoptic sono conformi ai requisiti della direttiva europea 93 42 cee. A010102 manufacturer, classification and intended use producer and production place. I, the undersigned, hereby declare that the equipment specified herein conforms with the applicable provisions of ec directive 93 42 eec concerning medical devices.

Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. All grossoptic ophthalmic lenses are in compliance with the requirements of european directive 93 42 eec. B council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169.

Italiano istruzioni per luso allineare il capo nella posizione neutra o occhi in avanti, salvo controindicazioni in base al protocollo in uso. 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. Medical devices internal market, industry, entrepreneurship. European medical device directive essential requirements. Direttiva 90496 cee del consiglio, del 24 settembre 1990, relativa alletichettatura nutrizionale dei prodotti alimentari. Pdf habitat e specie della direttiva 9243cee ed altri. 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. Whit vinyl powder free non sterile e free 0465 en 374 en 374 gkl en 388 c max 50 c min. Council directive 2006112ec of 28 november 2006 on the common system of value added tax. I, the undersigned, hereby declare that the equipment specified herein conforms with the applicable provisions of ec directive 9342eec concerning medical devices.

Direttiva del consiglio del 21 dicembre 1989 concernente il ravvicinamento delle legislazioni degli stati membri relative ai dispositivi di protezione individuale 89686cee avvertenza. Council directive 9342eec of 14 june 1993 concerning medical devices. 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. The product must be used exclusively on intact skin and free of ecchymoses or wounds. All grossoptic ophthalmic lenses are in compliance with the requirements of european directive 9342 eec.

Questions relating to the implementation of directive 200747 ec 1. Dispositivi medici detraibili nella dichiarazione dei. Council directive 93 42 eec of 14 june 1993 concerning medical devices. Medical device complying with european directive 9342cee iia class, designed and manufactured according to the iso9001, iso485, fu it xi ed. This document is in italian only and downloadable from. Direttiva 93 42 cee del consiglio, del 14 giugno 1993, concernente i dispositivi medici gazzetta ufficiale n. Cee translation into english examples italian reverso. Directive 93 42 cee du conseil, du 14 juin 1993, relative aux dispositifs medicaux. Lo stato dellarte delle poltrone dentali stateoftheart. Instructions for use and fluid control system operators.

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. 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. B council directive 9342eec of 14 june 1993 concerning. 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. Dpi ill categoria dm di i classe guanto di protezione contro agenti chimici e micro organismi. 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. Implementing directive 90496eec 21 the ministry of agriculture, fisheries and food maff. 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. Essential requirements annex i, 9342eec as compliance. Directive 200070ec of the european parliament and of the council of 16 november 2000. Composition des materiaux lycra, mtp5 40, jersey 28% polyamide. Martellago ve, declares on its own responsibility that itech mag is manufactured in conformity with directive 9342eec mdd, dated 14 june 1993 d. The social cost of the large number of accidents caused by the use of machinery can be reduced by.