| dbo:abstract |
Το IEC 62304 – λογισμικό – διαδικασίες είναι ένα πρότυπο το οποίο καθορίζει τις απαιτήσεις του κύκλου ζωής για την ανάπτυξη του και λογισμικού εντός ιατρικών συσκευών. Εναρμονίζεται με την Ευρωπαϊκή Ένωση (Ε.Ε.) και τις Ηνωμένες Πολιτείες Αμερικής (Η.Π.Α), και, επομένως, μπορεί να χρησιμοποιηθεί ως ένα για από αυτές τις δύο . (el) IEC 62304 – medical device software – software life cycle processes is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices. It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements. (en) La norma internazionale IEC 62304 Medical device software — Software life cycle processes - in Italia CEI EN 62304 software per dispositivi medici - processi del ciclo di vita del software è uno standard che specifica i requisiti del ciclo di vita per lo sviluppo di software medico e software all'interno di dispositivi medici. Si è armonizzata dall'Unione Europea (UE) e degli Stati Uniti (US), e, pertanto, può essere utilizzata come un punto di riferimento per soddisfare i requisiti normativi di entrambi questi mercati. (it) |
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Το IEC 62304 – λογισμικό – διαδικασίες είναι ένα πρότυπο το οποίο καθορίζει τις απαιτήσεις του κύκλου ζωής για την ανάπτυξη του και λογισμικού εντός ιατρικών συσκευών. Εναρμονίζεται με την Ευρωπαϊκή Ένωση (Ε.Ε.) και τις Ηνωμένες Πολιτείες Αμερικής (Η.Π.Α), και, επομένως, μπορεί να χρησιμοποιηθεί ως ένα για από αυτές τις δύο . (el) IEC 62304 – medical device software – software life cycle processes is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices. It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements. (en) La norma internazionale IEC 62304 Medical device software — Software life cycle processes - in Italia CEI EN 62304 software per dispositivi medici - processi del ciclo di vita del software è uno standard che specifica i requisiti del ciclo di vita per lo sviluppo di software medico e software all'interno di dispositivi medici. Si è armonizzata dall'Unione Europea (UE) e degli Stati Uniti (US), e, pertanto, può essere utilizzata come un punto di riferimento per soddisfare i requisiti normativi di entrambi questi mercati. (it) |
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