"serious adverse event" means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity;
"hud neželen dogodek" je kateri koli neželeni dogodek v zvezi z oskrbo, testiranjem, predelavo, shranjevanjem ali razdeljevanjem tkiv in celic, ki bi utegnil povzročiti prenos nalezljive bolezni, smrt ali ogroziti življenje ter izzvati stanja invalidnosti ali nezmožnosti za delo, ali katerega posledica je hospitalizacija ali obolevnost, ali ki podaljša hospitalizacijo ali obolevnost;