This document specifies requirements for the forensic process focusing on recognition, recording, collection, transport and storage of items of potential forensic value. It includes requirements for the assessment and examination of scenes but is also applicable to activities that occur within the facility. This document also includes quality requirements. This document is not applicable to procedures for the recovery of data from digital storage media which is covered by ISO/IEC 27037. However, the storage medium itself can yield additional items of forensic value (e.g. fingerprints or DNA). Annex D shows the applicability of this document to the forensic process.

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This document defines terms used in the ISO 21043 series of standards.

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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.

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