InVitroDiagnostics.docVIP

In Vitro Diagnostics (IVD) Compliance and What It Means In Practice 体外诊断的规范性及其在实践中的意义 by Sari Mannonen and Seppo Riikonen In vitro diagnostics (IVD) is the analysis of medical samples, such as blood, tissues, or urine, that are taken from patients or healthy individuals. 体外诊断就是将取自于病人或健康个体的医学样品，如血液、组织或尿液，进行分析。 After a medical examination, one of the first steps is often to take a blood sample and send it to the laboratory to carry out a number of tests. 体检之后，第一个步骤通常是采集血样，再把它（血样）送到实验室进行大量的测试。 These are IVD tests because many were originally performed in a test tube—“in vitro” is Latin for “in glass.” 因为许多这些体外诊断测试最初都是在试管里进行的，所以“体外”这个词的拉丁文意思是“在玻璃里”。 IVD tests are used to make a correct diagnosis for proper treatment (evidence-based medicine), but are also used extensively to follow up the treatment. 体外诊断检测过去不仅常用在寻找合适治疗方法作出正确诊断上，还广泛应用于跟踪治疗。 The IVD Directive 体外诊断的规章制度 The IVD Directive (98/79/EC) is the third in a series of European Directives on medical devices intended to provide regulations for the safe manufacture, supply,and use of devices in Europe. 欧洲体外诊断产品指令第98/79/EC号是欧洲医疗器械规章中为医疗器械的安全生产、经营和设备使用提供的第三部法规。 It has 24 articles and 10 annexes. 它共有24章和10个附件。 The articles cover general items such as scope and definitions, placing products on the market and putting them into service, free movement of CEmarked goods in European Union (EU) countries, reference to harmonized standards, vigilance and incident reporting, conformity assessment procedures,registration responsibilities, authorized representative,consequences of wrongly affixed CE marking, confidentiality,etc. 这些章节涵盖一般事项如范围和定义、产品在市场中的投放和投入使用、欧洲国家有“CE”标记产品的自由流通、协调标准参考、警告和事件报告、合格评定程序登记责任授权代表