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si tratta della cosiddetta sojt harmonization, di un'armonizzazione graduale.
maar dat is wat men noemt the soft harmonization, die geleidelijk aan tot stand wordt gebracht.
Last Update: 2014-02-06
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al termine del programma un/ece sulla misurazione del particolato, effettuato sotto l’egida del world forum for harmonization of vehicle regulations , la commissione provvederà:
na de afronding van het vn/ece-deeltjesmeetprogramma, dat wordt uitgevoerd onder leiding van het wereldforum voor de harmonisatie van voertuigreglementen, zal de commissie:
Last Update: 2014-10-23
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per essere considerata completa la documentazione tecnica deve come minimo trattare in modo adeguatamente approfondito gli elementi elencati nel documento «summary technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices (sted)» della global harmonization task force, nonché tutti gli elementi aggiuntivi richiesti dalla legislazione europea, oppure, per quanto riguarda i dispositivi medico-diagnostici in vitro, nel documento «summary technical documentation (sted) for demonstrating conformity to the essential principles of safety and performance of in vitro diagnostic medical devices» nonché tutti gli elementi aggiuntivi imposti dalla legislazione europea; i documenti sono reperibili all’indirizzo http://www.imdrf.org/ghtf/ghtf-archives-sg1.asp.
om als volledig te worden beschouwd, worden in technische documentatie ten minste die elementen met gepaste grondigheid behandeld die in het document „summary technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices (sted)” van de werkgroep wereldwijde harmonisatie worden vermeld, alsmede andere door de europese wetgeving vereiste elementen, of, voor medische hulpmiddelen voor in-vitrodiagnostiek, „summary technical documentation (sted) for demonstrating conformity to the essential principles of safety and performance of in vitro diagnostic medical devices”, alsmede andere door de europese wetgeving vereiste elementen; voor de genoemde documenten zie http://www.imdrf.org/ghtf/ghtf-archives-sg1.asp
Last Update: 2014-11-08
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