The standards developed at national level (UNI Standards), European Standards (CEN Standards) and international standards (ISO standards), are quality standards useful for implementing quality in biobanking. The "UNI/ISO 20387 Biotechnology - Biobanking - General requirements for biobanking", published in August 2018 and designed to all operators of biobanks that preserve biological material for research and biotechnological development, has the aim of promoting trust in biobanking. The adoption and implementation of this standard by biobanks will make available biological samples and associated quality data and materials to all private and public R&D sectors, facilitating acquisition of knowledge and the development of applications market. In Italy, the accreditation of biobanks in accordance with the requirements of this standard will be operated by ACCREDIA.

BBMRI.it, through the ISS experts representing UNI (Ente Italiano di Normazione), contributes to the international standardization work on research biobanking conducted by all the working groups of the ISO/TC 276 Biotechnology (https: // www. iso.org/committee/4514241.html) that are developing a series of standards on analytical methods for biological material and for the processing and integration of associated data.

In addition to the standards developed by TC 276, a series of technical specifications (ISO/TS) relating to pre-analytical procedures for human samples are developed by ISO/TC212 (https://www.iso.org/committee/54916.html) and available for biobanks.

For more information on Standards, Regulations and Guidelines visit the website: http://www.bbmri-eric.eu/services/standardisation/
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