ISO 18385:2016规定了用于收集、储存和分析用于法医DNA目的的生物材料的产品的生产要求，但不包括用于扩增后分析的耗材和试剂。 本国际标准涵盖的消耗品和试剂包括用于证据收集的消耗品和试剂（取样试剂盒），如拭子、容器和包装，以及用于DNA样本分析的产品，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。 ISO 18385:2016适用于不需要清洁以继续使用的耗材和试剂的生产。本国际标准不包括技术产品规范（i。 e、 产品设计）。 ISO 18385:2016不包括微生物检测。 ISO 18385:2016规定了一项要求，要求制造商将全球法医界使用的产品中出现可检测人类核DNA污染的风险降至最低。

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. ISO 18385:2016 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). ISO 18385:2016 excludes microbiological testing. ISO 18385:2016 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.