AS ISO 18385:2017 pdf free.Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes – Requirements.
AS ISO 18385 was produced with the aim to create global standards for manufacturers of forensic products used in human DNA analysis. Inadvertent contamination by manufacturers of consumables and reagents, when combined with the improved sensitivity of DNA testing methods, increasingly interferes with forensic analysis.
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 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.
4 Types of products
4.1 General
For the purposes of this International Standard, the products used in the collection, storage, and analysis of biological material for forensic DNA purposes are as outlined below. These products include, but are not limited to, the examples listed in 4.2, 4.3, and 4.4.
4.2 Products that come into direct contact with biological stains or material potentially containing human DNA
These products are considered to be high risk because the contaminating biological material or DNA is likely to be transferred. As a result, they should undergo post-production treatment provided it does not damage the product.