Biotechnology - Biobanking - General requirements for biobanking
Biotechnology - Biobanking - General requirements for biobanking
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EN ISO 20387:2020/A11:2024 - Biotechnology - Biobanking - General requirements for biobanking is a CEN-adopted amendment to the ISO biobanking standard. Approved by CEN on 12 June 2024, this amendment updates the European implementation of ISO 20387:2020 and is intended to support accreditation and conformity assessment across EU and EFTA member states. The document provides a voluntary, harmonized framework for the competence, impartiality and consistent operation of biobanks and biorepositories.
Keywords: EN ISO 20387, biobanking standard, biobank accreditation, biorepository quality, biospecimen management
The amendment keeps the standard’s focus on high-level requirements for biobanking and maps directly to accreditation requirements under Regulation (EC) No 765/2008. Major technical topics and requirement areas highlighted in the document include:
The standard also includes an informative Annex ZA that explains the relationship between EN ISO 20387 and EU accreditation legislation.
EN ISO 20387:2020/A11:2024 is designed to be applied by organizations that collect, process, store and distribute biological materials and associated data, to ensure reliable, reproducible and legally defensible biospecimens. Typical applications include:
For implementation, consult the full EN ISO 20387:2020/A11:2024 text and national standards bodies for guidance on accreditation and legal alignment.
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