Ehdotuksen tiedot

This document specifies requirements for sample containers intended for the storage of biological materials in biobanks. In addition to general requirements, this also includes special requirements depending on the storage conditions, the biological material and the intended use, as well as requirements for documentation and quality control. These requirements ensure a defined quality for the sample containers. This document specifies test criteria and test methods that enable proof of compliance with the requirements. This document is primarily aimed at manufacturers that produce sample containers for the storage of biological materials. Biobanks, submitters and users of biological sample material, and organizations that monitor or control the work of biobanks can also use this document.