BS ISO 18385:2016 pdf download

BS ISO 18385:2016 pdf download.Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements
1 Scope
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.
5.7 Staff contamination detection provision
Manufacturers shall document and implement a policy for the collection of relevant voluntary reference samples from personnel involved in the production of products. NOTE 1 Refer to legislative or regulatory restrictions or preclusion in your jurisdiction regarding the collection of voluntary reference samples from staff. A voluntary reference sample should be collected, with written permission, from personnel who have the potential to introduce DNA into the product. Personnel included in the staff contamination detection system should be determined based on risk. If a sample is provided, a relevant DNA profile (see Annex C) shall be generated and recorded for quality assurance purposes. Information on the staff contamination detection system shall be documented. NOTE 2 Humans are constantly shedding DNA and the inadvertent contamination of product is a constant and unavoidable risk regardless of control measures implemented. When staff contamination of a product occurs, it can lead them to being erroneously linked by police to a crime or a series of crimes. A staff contamination detection system is used to detect the occurrence of contamination and protect against an erroneous linkage. NOTE 3 The International Commission on Missing Persons provides a secure platform as a repository for DNA profiles of employees of manufacturing companies (www.ic-mp.org).