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Padomes Direktīvu 93/42/EEK par medicīnas ierīcēm. Saskaņotie un starptautiskie standarti: - EN ISO 14155:2011 Cilvēkiem paredzētu medicīnisko ierīču klīniskā izpēte - laba klīniskā prakse; - EN ISO 14971:2012 Medicīnas ierīces - riska pārvaldības pielietojums medicīnas ierīcēm. Eiropas vadlīnijas:
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