BS ISO 18385:2016规定了本系列产品的生产要求， 储存和分析用于法医DNA目的的生物材料，但不包括这些消耗品和 用于扩增后分析的试剂。本国际标准涵盖的消耗品和试剂包括用于证据的消耗品和试剂 采集（采样套件），如拭子、容器和包装，以及在实验室使用的产品 DNA样本分析，如试管和其他塑料制品、一次性实验室外套、手套和 其他消耗品。本国际标准适用于无需特殊要求的耗材和试剂的生产 清洁以备继续使用。本国际标准不包括技术产品规范 （即产品设计）。本国际标准不包括微生物检测。本国际标准规定了制造商将发生风险降至最低的要求 全球法医界使用的产品中可检测到的人类核DNA污染。国际标准的概述如图1所示。交叉引用:ISO 3696ISO 9001ISO 10993ISO 10993-7ISO 11135ISO 11137ISO 11137-2ISO 13485ISO 1464ISO 14644-1ISO 14644-2ISO 14644-4ISO 14644-5ISO 14644-7ISO 14644-8ISO 14698ISO 14937ISO 14971ISO 15189ISO/IEC 17025ISO 17665ISO 31000ISO/IEC 31010AAMI TIR 17:2008AAMI TIR 52购买本文件时提供的所有现行修订版均包含在购买本文件中。

BS ISO 18385:2016 specifies requirements for the production of products used in the collection, storage, and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis.The consumables and reagents covered by this International Standard include those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as tubes and other plasticware, disposable laboratory coats, gloves, and other consumables.This International Standard applies to the production of consumables and reagents which do not require cleaning for continued use. This International Standard does not cover technical product specifications (i.e. product design).This International Standard excludes microbiological testing.This International Standard specifies a requirement for manufacturers to minimize the risk of occurrence of detectable human nuclear DNA contamination in products used by the global forensic community.An overview of the International Standard is provided in Figure 1.Cross References:ISO 3696ISO 9001ISO 10993ISO 10993-7ISO 11135ISO 11137ISO 11137-2ISO 13485ISO 14644ISO 14644-1ISO 14644-2ISO 14644-4ISO 14644-5ISO 14644-7ISO 14644-8ISO 14698ISO 14937ISO 14971ISO 15189ISO/IEC 17025ISO 17665ISO 31000ISO/IEC 31010AAMI TIR 17:2008AAMI TIR 52All current amendments available at time of purchase are included with the purchase of this document.