Dec 05 2016
Your ISO 18385 Questions Answered!
You may have heard of the new ISO 18385 Forensic Grade Standard, but do you still have questions about what it is and how it will effect the products you use in your lab each day? We’ve created a resource of frequently asked questions to help you understand what the new standard really means to you.
This post originally appeared on the Promega website
What is ISO 18385?
ISO 18385, published in February 2016, is a new ISO standard for forensic products intended to minimize the risk of human DNA contamination during the manufacture of products used to collect, store, and analyze biological material for forensic purposes.
For more information on how the standard came to be, please read ISO 18385: The Creation of a Forensic Grade Standard
Your ISO 18385 Forensic Grade questions answered - everything you want to know about the new standard! Click To Tweet
What do forensic labs need to do to comply with this standard?
ISO 18385 is a standard for forensic manufacturers and does not require any specific action by forensic laboratories. However, you may wish to review your laboratory SOPs for references to specific product catalog numbers and determine if they need to be updated.
What actions has Promega taken to comply with ISO 18385?
We have revised quality control testing and certificates of analysis, as necessary, to ensure alignment with the standard. We treat plastics for our forensic product line, such as primary packaging materials and consumables, with ethylene oxide to mitigate the impact of possible human DNA contamination. As a result, the catalog numbers for some treated plastic consumable products have changed.
What is ethylene oxide (EO) treatment?
EO treatment is a sterilization technology used for medical devices. The treatment is very effective at destroying DNA and rendering it unamplifiable in PCR and is an effective post-production treatment method for minimizing DNA contamination on plastics.
Which plastic products are treated with ethylene oxide?
Plastic tubes and bottles used to package DNA extraction, DNA quantitation and STR amplification reagents are treated with ethylene oxide. Additionally, plastic products that are intended for use in DNA extraction are also treated with ethylene oxide.
How will I know which products comply with ISO 18385?
Promega products that are manufactured in alignment with ISO 18385 will be clearly labeled with a blue forensic grade logo. They include forensic products intended for DNA extraction, DNA quantitation and STR amplification.
Where can I get more information?
The articles and webinars listed below contain additional details about how Promega prepared to manufacture products in alignment with the standard.
- White paper
- Forensic-Grade products for human identification: Preparing for ISO 18385 requirements, (2014) Promega Corporation Web site.
- Profiles in DNA article
- Raymond, K., Setlak, J. and Stollberg, C. Examination of proposed manufacturing standards using low template DNA (2013) Profiles in DNA.
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