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 3696
ISO 9001
ISO 10993
ISO 10993-7
ISO 11135
ISO 11137
ISO 11137-2
ISO 13485
ISO 14644
ISO 14644-1
ISO 14644-2
ISO 14644-4
ISO 14644-5
ISO 14644-7
ISO 14644-8
ISO 14698
ISO 14937
ISO 14971
ISO 15189
ISO/IEC 17025
ISO 17665
ISO 31000
ISO/IEC 31010
AAMI TIR 17:2008
AAMI TIR 52


All current amendments available at time of purchase are included with the purchase of this document.