BS ISO 18385:2016

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Abbreviated terms
4 Types of products
5 Quality management systems
6 Human DNA contamination risk management
7 Environmental human DNA monitoring
8 Requirements for products subject to post-production
   treatment
9 Requirements for products not subject to post-production
   treatment
10 Product packaging, labelling, and documentation
Annex A (normative) - Compliance testing
Annex B (informative) - Guidance on the effectiveness of
        post-production treatments currently used in the
        manufacture of products
Annex C (informative) - Relevant markers for DNA profiling
Bibliography

Provides 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.

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 Figure1. Figure1 Overview of the processes covered by this International Standard