标准编号:ISO 18385:2016

中文名称:在产品用于法医收集、存储和分析生物材料时最大限度地减少人类DNA污染的风险 要求

英文名称:Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements

发布日期:2016-02

标准范围

This International Standard 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 andreagents used in post-amplification analysis.The consumables and reagents covered by this International Standard include those used for evidencecollection (sampling kits), such as swabs, containers, and packaging, and also products used in theanalysis of DNA samples, such as tubes and other plasticware, disposable laboratory coats, gloves, andother consumables.This International Standard applies to the production of consumables and reagents which do not requirecleaning 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 occurrenceof detectable human nuclear DNA contamination in products used by the global forensic community.An overview of the International Standard is provided in Figure 1.

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