Ovim delom standarda daju se zahtevi za pripremanje planova kliničkih istraživanja za klinička istraživanja medicinskih sredstava.
Директиве повезане са овим стандардом
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
ПОВУЧЕН
SRPS EN ISO 14155-2:2011
95.99
Повучен
30. 9. 2011.
ПОВУЧЕН
SRPS EN ISO 14155:2011
МИНИСТАРСТВО ЗДРАВЉА