Ehdotuksen tiedot

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure that collections of biological material and associated data are of appropriate quality. This document is applicable to all organizations performing biobanking. This can include biobanking of biological material: Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks. This document does not apply to biological material intended for therapeutic use.