Látal Tomás
TRIOS Ltd., Prague, Czech Republic.
Klin Mikrobiol Infekc Lek. 2009 Dec;15(6):196-200.
In vitro diagnostics is the basic principle of most laboratory activities. It influences three quarters of diagnostic decisions, affecting more than a half of direct costs of provided health care. Production, storing and distribution of in vitro diagnostic medical devices, as well as the laboratory diagnostic process itself (use of in vitro diagnostics) must strictly adhere to all legislative provisions relating to in vitro diagnostics. The article provides a detailed explanation of (i) Directive 98/79/CE on in vitro diagnostic medical devices, (ii) Act No. 22/1997 Coll. on technical requirements for products, (iii) Act No. 123/2000 Coll. on medical devices and (iv) Government Regulation No. 453/2004 on technical requirements for in vitro diagnostic medical devices.
体外诊断是大多数实验室活动的基本原则。它影响着四分之三的诊断决策，影响着所提供医疗保健直接成本的一半以上。体外诊断医疗器械的生产、储存和分销，以及实验室诊断过程本身（体外诊断的使用）必须严格遵守与体外诊断相关的所有法律规定。本文详细解释了：（i）关于体外诊断医疗器械的98/79/CE号指令；（ii）关于产品技术要求的第22/1997 Coll.号法案；（iii）关于医疗器械的第123/2000 Coll.号法案；以及（iv）关于体外诊断医疗器械技术要求的第453/2004号政府条例。
