Avtor/Urednik		Rudolf, Martina; Krbavčič, Aleš
Naslov		Kritičen pogled na ovrednotenje medicinskih propomočkov kot končnih izdelkov na primeru sterilnih podkožnih igel za enkratno uporabo
Prevedeni naslov		Critical view on the evaluation of medical devices as finished products on the example of sterile hypodermic needles for single use
Tip		članek
Vir		Farm Vestn
Vol. in št.		Letnik 50, št. 1
Leto izdaje		1999
Obseg		str. 27-34
Jezik		slo
Abstrakt		Majority of medical devices is on the first look uncomparable with classical medicinal products. We cannot find monographs for the evaluation of all this products in pharmacopeas. There are other international standards, but they are not defining particular parameters in the way as we are used to with pharmacopeas. On the example of sterile hypodermic needles for single use we are going to show what does compliance with the international standard mean. We are going to warn about the critical points, which are not included in these standards.
Izvleček		Večina medicinskih pripomočkov že na prvi pogled ni primerljiva s klasičnimi farmacevtskimi izdelki. Monografij za ovrednotenje večine teh izdelkov v farmakopejah ne najdemo. Obstajajo drugi mednarodni standardi, ki pa posameznih lastnosti ne opredeljujejo tako kot smo vajeni uporabniki farmakopej. Na primeru sterilnih podkožnih igel za enkratno uporabo bomo pokazali, kaj pravzaprav pomeni skladnost z enim od mednarodnih standardov. Opozorili bomo na kritične točke, ki v teh standardih niso zajete.
Deskriptorji		NEEDLES QUALITY CONTROL LEGISLATION, DRUG MATERIALS TESTING EQUIPMENT AND SUPPLIES