本国际标准建议在进行分子测定前，在检查前阶段处理，记录，储存和加工用于RNA检查的冷冻组织标本。本国际标准适用于分子体外诊断检查，包括医学实验室进行的实验室开发测试。它还旨在由实验室客户，体外诊断开发人员和制造商使用，也适用于执行生物医学研究，生物银行和监管机构的机构和商业组织。 组织中的RNA谱在收集之前和之后都可以发生显着变化，并且可以在不同的供体/患者组织中变化不同。 因此，必须采取特殊措施，尽可能减少组织内描述的变化和修改以便随后的RNA检查。 在文件中未涵盖在冷冻前进行化学稳定预处理的组织。 注国际，国家或地区的法规或要求也可能适用于本国际标准中涉及的具体议题

This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate RNA extracted from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.