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SRPS EN ISO 20387:2021

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

Feb 26, 2021
Mar 31, 2022

General information

60.60     Feb 26, 2021



European Norm


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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 directives

Directives related to this standard.


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


SRPS EN ISO 20387:2021
60.60 Standard published
Feb 26, 2021

Related project

Adopted from EN ISO 20387:2020

Adopted from ISO 20387:2018