本国际标准建议在进行分子测定之前，在预检阶段进行基因组DNA分析检查的静脉全血标本的处理，记录，储存和加工。本国际标准涵盖静脉采血管采集的标本。本国际标准适用于分子体外诊断检查，包括由实验室开展的实验（例如医学实验室），也由实验室客户，体外诊断开发人员和制造商使用，也适用于机构和商业组织的执行生物医学研究，生物银行和监管机构）。 血液基因组DNA可以在采血后分裂或降解。因此，需要采取特殊措施，确保优质血液样本进行基因组DNA分析。这对于需要高分子量DNA的分析测试方法尤为重要。 必须采取不同的专门措施来保存无血液循环DNA，本国际标准中没有描述。血液中循环的无细胞DNA包含在ISO 20091-3，分子体外诊断检查中

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for stabilizing blood cell free circulating DNA, which are not described in this document. NOTE Circulating cell free DNA in blood is covered in ISO 20186-3. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom. DNA in pathogens present in blood is not covered by this document.