oSIST prEN ISO 20387:2025
(Main)Biotechnology - Biobanking - General requirements for biobanks (ISO/DIS 20387:2025)
Biotechnology - Biobanking - General requirements for biobanks (ISO/DIS 20387:2025)
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 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.
Biotechnologie - Biobanking - Allgemeine Anforderungen an Biobanken (ISO/DIS 20387:2025)
Biotechnologie - Mise en banque de matériel biologique - Exigences générales relatives pour les biobanques (ISO/DIS 20387:2025)
Le présent document spécifie les exigences générales pour la compétence, l'impartialité et l'exploitation cohérente des biobanques, y compris les exigences en matière de contrôle qualité, pour assurer la qualité appropriée des collections de matériels biologiques et des données associées.
Le présent document est applicable à toutes les organisations qui pratiquent le «biobanking» pour la recherche et le développement, y compris le «biobanking» de matériels biologiques issus d'organismes pluricellulaires (par exemple humains, animaux, champignons et végétaux) et de micro-organismes.
Les utilisateurs des biobanques, les autorités réglementaires, les organisations et les systèmes utilisant l'évaluation par les pairs, les organismes d'accréditation et d'autres entités peuvent également utiliser ce document pour confirmer ou reconnaître la compétence des biobanques.
Le présent document ne s'applique pas aux matériels biologiques destinés à la production de denrées alimentaires/d'aliments pour animaux, aux laboratoires effectuant des analyses pour la production de denrées alimentaires/d'aliments pour animaux et/ou à une utilisation thérapeutique.
NOTE 1 Des réglementations ou exigences internationales, nationales ou régionales peuvent également s'appliquer à des sujets spécifiques traités dans le présent document.
NOTE 2 Pour les entités ayant à traiter des matériels humains acquis et utilisés à des fins diagnostiques et thérapeutiques, l'ISO 15189 et les autres normes cliniques doivent s'appliquer en priorité.
Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo (ISO/DIS 20387:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo (ISO/DIS
20387:2025)
Biotechnology - Biobanking - General requirements for biobanks (ISO/DIS 20387:2025)
Biotechnologie - Biobanking - Allgemeine Anforderungen an Biobanken (ISO/DIS
20387:2025)
Biotechnologie - Mise en banque de matériel biologique - Exigences générales relatives
pour les biobanques (ISO/DIS 20387:2025)
Ta slovenski standard je istoveten z: prEN ISO 20387
ICS:
07.080 Biologija. Botanika. Zoologija Biology. Botany. Zoology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 20387
ISO/TC 276
Biotechnology — Biobanking —
Secretariat: DIN
General requirements for biobanks
Voting begins on:
ICS: 07.080
2025-10-29
Voting terminates on:
2026-01-21
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 20387:2025(en)
DRAFT
ISO/DIS 20387:2025(en)
International
Standard
ISO/DIS 20387
ISO/TC 276
Biotechnology — Biobanking —
Secretariat: DIN
General requirements for biobanks
Voting begins on:
ICS: 07.080
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
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RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
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Published in Switzerland Reference number
ISO/DIS 20387:2025(en)
ii
ISO/DIS 20387:2025(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 10
4.1 General .10
4.2 Impartiality .11
4.3 Confidentiality .11
5 Structural requirements .12
6 Resource requirements .13
6.1 General . 13
6.2 Personnel . 13
6.2.1 General . 13
6.2.2 Competence and training . . .14
6.3 Facilities/dedicated areas and environmental conditions .14
6.4 Externally provided critical processes and services (Outsourcing) . 15
6.5 Externally provided products and services . 15
6.6 Equipment .16
7 Process requirements . 17
7.1 General .17
7.2 Collection of biological material and associated data .18
7.2.1 Documented information .18
7.2.2 Collection of biological material .18
7.3 Acquisition and reception of biological material and associated data .19
7.4 Transport of biological material and associated data .19
7.5 Traceability of biological material and associated data . 20
7.6 Processing, testing and preservation of biological material . 20
7.7 Storage of biological material and associated data.21
7.8 Retrieval of biological material and associated data .21
7.9 Distribution of biological material and associated data . 22
7.10 Disposal of biological material and associated data . 22
7.11 Quality control of biological material and associated data . 22
7.11.1 General . 22
7.11.2 Quality control of processes. 23
7.11.3 Quality control of biological material . 23
7.11.4 Quality assurance for biological material . 23
7.11.5 Quality control of data .24
7.12 Validation and verification of methods .24
7.12.1 General .24
7.12.2 Validation .24
7.12.3 Verification .24
7.13 Management of information and data . 25
7.14 Nonconforming output . 25
7.15 Report requirements. 26
7.15.1 General . 26
7.15.2 Content of the report . 26
7.15.3 Preparation of the report . 28
7.15.4 Amendments to reports . 29
7.16 Complaints. 30
8 Management system requirements .30
8.1 General . 30
iii
ISO/DIS 20387:2025(en)
8.2 Documented information for the management system .31
8.3 Control of management system documents .31
8.4 Control of records .32
8.5 Actions to address risks and opportunities .32
8.6 Improvement .
...
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