Publication de la nouvelle norme ISO 21899 relative aux biobanques » Luxembourg Institute of Health
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04 août 2020 2minutes

Publication de la nouvelle norme ISO 21899 relative aux biobanques

Veuillez noter qu’à l’exception du titre et du résumé, cet article est uniquement disponible en anglais.

L’ISO 21899, une nouvelle norme relative aux biobanques à laquelle l’IBBL a largement contribué, a été officiellement publiée en juin 2020. La norme définit les exigences générales pour la validation et la vérification des méthodes de traitement du matériel biologique dans les biobanques, et servira de norme complémentaire à l’ISO 20387 (Exigences générales relatives au « biobanking »).

Many biobanks perform biospecimen processing activities to isolate specific components of interest from the collected biological samples, to be used for biomedical research purposes. These processing methods include DNA, RNA and protein extractions from a variety of samples, such as blood, tissue, seeds, bacteria or other biological materials. In order to ensure the good quality and fitness for purpose of the resulting processing outputs for their intended downstream use, processing methods need to be validated and their outputs annotated and qualified.

In this context, the new ISO 21899 was developed by Working Group 2 of the ISO technical committee 276 ‘Biotechnology’, to define the specific requirements for the validation of processing methods, with the aim of assisting biobank laboratories in performing sample processing. IBBL’s Dr Fay Betsou contributed significantly to the elaboration of the norm, which was published in June 2020.

“We are really pleased to have represented Luxembourg’s contribution in the development of ISO 21899. The new standard strengthens the quality management system of any biobank laboratory performing the processing of biological materials, giving more credibility to the organisation. In addition, ISO 21899 complements ISO 20387, originally published in 2018, further reinforcing the progressive standardisation of biobanking activities at the international level”, comments Dr Betsou.

ISO 21899:2020 can be accessed here.

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