DIN Standards Committee Health Technologies
Biotechnology - Biobanking - General requirements for biobanking
Abstract
This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality. This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development. 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 food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use. NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document. NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.
Begin
2024-01-04
WI
JT001077
Planned document number
DIN EN ISO 20387 rev
Project number
17600068
Responsible national committee
NA 176-09-02-02 AK - Biobanks/Bioresources
Responsible european committee
CEN/CLC/JTC 1 - Criteria for conformity assessment bodies
Responsible international committee
ISO/TC 276/WG 2 - Biobanks and bioresources
