EN ISO 20387:2020

Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018) EN ISO 20387:2020

Publication date:   Nov 17, 2020

General information

60.60 Standard published   Sep 23, 2020

CEN/CENELEC

CEN/CLC/JTC 1 Criteria for conformity assessment bodies

European Norm

07.080   Biology. Botany. Zoology

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Scope

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.

Related legislation

Legislation related to this standard

765/2008

REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

Life cycle

NOW

PUBLISHED
EN ISO 20387:2020
60.60 Standard published
Sep 23, 2020

REVISED BY

IN_DEVELOPMENT
prEN ISO 20387 rev

Relations

Adopted from ISO 20387:2018 IDENTICAL