(SA), the Australian member body to the International Organization for Standardization
(ISO), has submitted a proposal to ISO for a new International Standard on minimizing the risk of contamination in products used to collect and analyze biological material for forensic DNA purposes. As the U.S. member body to ISO, the American National Standards Institute
(ANSI) invites all interested stakeholders to submit comments on the proposal by Friday, July 27, 2012.
The proposed new work item would set particular criteria around which the consumables used in forensic DNA collection and analysis should be manufactured. The standard would specify provisions for the production of products used in forensic DNA collection and analysis. Products to be covered by the scope of this standard include single-use items used for evidence collection (including those used in DNA kits) such as swabs, containers, and packaging, as well as products used in the analysis of DNA samples, such as tubes and other plastic ware, chemicals and reagents, disposable laboratory coats, gloves, and masks, and other consumables. The scope does not include technical product specifications, nor does it cover instruments used for the analysis of biological material, items used in the process post-DNA amplification, items used in other non DNA forensic disciplines, and multiple use items. The proposed work could be undertaken by a new Subcommittee (SC) of ISO Technical Committee (TC) 194, Biological evaluation of medical devices,
or a new TC or Project Committee (PC). All comments on the proposal should be sent to Steven P. Cornish, ANSI senior director for international policy (firstname.lastname@example.org
). Feedback received by the July 27 deadline will be reviewed and compiled for the recommended ANSI position and comments, which will then be presented to the ANSI ISO Council (AIC) for formal approval. Read the SA proposal
ANSI has published an explanatory information document outlining the process used to develop U.S. positions on issues and activities under consideration by ISO and IEC. Click here to download the document