Author/Editor     Brus-Kovač, Boža; Krbavčič, Aleš
Title     Obvezilni in sanitetni material ter problematika z vidika njegove kakovosti
Translated title     Surgical dressings and problems regarding their quality
Type     članek
Source     Farm Vestn
Vol. and No.     Letnik 50, št. 4
Publication year     1999
Volume     str. 471-88
Language     slo
Abstract     Surgical dressings represent a group of products, which are classified according to the Medicinal Product Act as medical devices. Medical devices must be manufactured in such a way, that their duality, efficiency and safety is assured. Surgical dressings are very large and different group of products. Materials used for manufacture of surgical dressings vary from simple cotton and viscose to multilayer products of hidrocoloids, hidrogels, alginates and other materials. Modern contact surgical materials are very difficult to classify, because they are developing and changing very quickly. At the same time they are becoming wound specific. In current pharmacopoeias there are only monographs for evaluation of basic surgical material, such as cotton and viscose. There are other international standards, but they are not defining particular parameters in the way we are used to with pharmacopoeias. Beside that for those products harmonised european standards are not available. In the quality control of surgical dressings the main problem is that there are only few common parameters of evaluation, such as sterility, microbiological quality and safety of these products. Only sterility testing is well defined.
Summary     Obvezilni in sanitetni material predstavlja skupino izdelkov, ki sodijo po Zakonu o zdravilih med medicinske pripomočke. Medicinski pripomočki morajo biti izdelani na tak način, da je zagotovljena njihova kakovost, uporabnost in neškodljivost. Obvezilni in sanitetni material so velika in različna skupina izdelkov. Materiali, iz katerih se izdelujejo so različni, od enostavnega bombaža in viskoze do večplastnih izdelkov iz hidrokoloidov, hidrogelov, alginatov in drugih materialov. Sodobne stične sanitetne materiale zelo težko klasificiramo, ker se razvijajo in spreminjajo zelo hitro hkrati pa postajajo tudi specifični glede na vrsto rane. V veljavnih farmakopejah najdemo le monografije za ovrednotenje osnovnih materialov, kot sta bombaž in viskoza. Obstajajo drugi mednarodni standardi, ki pa posameznih lastnosti ne opredeljujejo tako kot smo vajeni uporabniki farmakopej. Poleg tega za ovrednotenje teh izdelkov ne obstajajo harmonizirani evropski standardi. Pri nadzoru kakovosti obvezilnega in sanitetnega materiala je glavni problem, da ima skupina obvezilnega in sanitetnega materiala le nekaj skupnih parametrov, kot so sterilnost, milkrobiološka kakovost in neškodljivost. Dorečeno je le preskušanje sterilnosti.
Descriptors     BANDAGES
PHARMACOPOEIAS
SURGICAL EQUIPMENT
OCCLUSIVE DRESSINGS
BIOLOGICAL DRESSINGS
WOUND HEALING
SURGICAL WOUND INFECTION