EN ISO 20387:2020/A11:2024

Biotechnology - Biobanking - General requirements for biobanking

Biotechnologie - Biobanking - Allgemeine Anforderungen an das Biobanking

Biotechnologie - «Biobanking» - Exigences générales relatives au «biobanking»

Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo

General Information

• Status: Published
• Publication Date: 16-Jul-2024
• ICS: 07.080 - Biology. Botany. Zoology
• Technical Committee: CEN/CLC/TC 1 - Criteria for conformity assessment bodies
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 17-Jul-2024
• Due Date: 27-Oct-2026
• Completion Date: 17-Jul-2024
• Directive: 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
• Mandate: M/580 - Standardisation request to the European Committee for Standardisation and the European Committee for Electrotechnical Standardisation in the area of accreditation and conformity assessment
• Ref Project: SIST EN ISO 20387:2020/A11:2024 - Biotechnology - Biobanking - General requirements for biobanking

Relations

• Amends: EN ISO 20387:2020 - Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
• Effective Date: 26-Jun-2024

Overview

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

Key Topics

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:

• General requirements - scope, impartiality and competence principles for biobanks
• Structural requirements - organizational structure and governance for biobanking operations
• Resource requirements - personnel competence, facilities, equipment and infrastructure needed to maintain biospecimen quality
• Process requirements - handling, collection, storage, retrieval and traceability of biological materials and associated data
• Management system requirements - quality management, documentation, continual improvement and records to support accreditation

The standard also includes an informative Annex ZA that explains the relationship between EN ISO 20387 and EU accreditation legislation.

Practical Applications

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:

• Establishing or upgrading a biobank quality management system for research, clinical trials or diagnostics
• Preparing for accreditation or conformity assessment against EU requirements
• Harmonizing sample handling, storage and data-tracking practices across multi-site biorepository networks
• Supporting sample traceability and specimen integrity for translational research, personalized medicine and genomics

Who Should Use This Standard

• Biobank managers and technicians
• Quality and compliance officers in research institutions, hospitals and biotech companies
• Accreditation bodies and auditors assessing biobank competence
• Contract research organizations (CROs) and sample service providers
• Policy makers and regulators aligning national standards with EU legislation

Related Standards and Notes

• This amendment modifies EN ISO 20387:2020 and is part of the CEN/CENELEC program supporting Regulation (EC) No 765/2008 (accreditation).
• The document is available in English, French and German and will be adopted nationally by CEN members by January 2025.

For implementation, consult the full EN ISO 20387:2020/A11:2024 text and national standards bodies for guidance on accreditation and legal alignment.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2024
Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo
Biotechnology - Biobanking - General requirements for biobanking
Biotechnologie - Biobanking - Allgemeine Anforderungen an Biobanking
Biotechnologie - «Biobanking» - Exigences générales relatives au «biobanking»
Ta slovenski standard je istoveten z: EN ISO 20387:2020/A11:2024
ICS:
07.080 Biologija. Botanika. Zoologija Biology. Botany. Zoology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN ISO 20387:2020/A11

NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2024
ICS 07.080
English version
Biotechnology - Biobanking - General requirements for
biobanking
Biotechnologie - "Biobanking" - Exigences générales Biotechnologie - Biobanking - Allgemeine
relatives au "biobanking" Anforderungen an Biobanking
This amendment A11 modifies the European Standard EN ISO 20387:2020; it was approved by CEN on 12 June 2024.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2024 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 20387:2020/A11:2024 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the
requirements of Regulation (EC) No 765/2008 of the European Parliament and of
the Council of 9 July 2008 setting out the requirements for accreditation and
repealing Regulation (EEC) No 339/93 aimed to be covered . 4

European foreword
This document (EN ISO 20387:2020/A11:2024) has been prepared by Technical Committee
CEN/CLC/JTC 1 “Criteria for conformity assessment bodies” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 20387:2020 shall be given the status of a national
...