SIST EN ISO 20387:2020
(Main)Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
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.
Biotechnologie - Biobanking - Allgemeine Anforderungen an Biobanking (ISO 20387:2018)
Biotechnologie - «Biobanking» - Exigences générales relatives au «biobanking» (ISO 20387:2018)
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 20387:2018)
Ta dokument določa splošne zahteve za usposobljenost, nepristranskost in dosledno delovanje biobank, vključno z zahtevami za nadzor kakovosti, da se zagotovi primerna kakovost zbirk biološkega materiala in podatkov.
Ta dokument se uporablja za vse organizacije, ki izvajajo biobančništvo, vključno z biobančništvom biološkega materiala iz večceličnih organizmov (npr. ljudi, živali, gliv in rastlin) ter mikroorganizmov za raziskave in razvoj.
Uporabniki biobank, regulativni organi, organizacije in sheme, ki uporabljajo medsebojno ocenjevanje, akreditacijski organi ter drugi lahko prav tako uporabljajo ta dokument za potrjevanje ali priznavanje usposobljenosti biobank.
Ta dokument se ne uporablja za biološki material, namenjen za proizvodnjo hrane/krme, laboratorije, ki izvajajo analize za tovrstno proizvodnjo, in/ali terapevtsko uporabo.
OPOMBA 1: Za določene teme, zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.
OPOMBA 2: Za subjekte, ki ravnajo s človeškim materialom, pridobljenim in uporabljenim za namene diagnostike in zdravljenja, se v prvi vrsti uporabljajo standard ISO 15189 in drugi klinični standardi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2020
Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo (ISO
20387:2018)
Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
Biotechnologie - Biobanking - Allgemeine Anforderungen an Biobanking (ISO
20387:2018)
Biotechnologie - «Biobanking» - Exigences générales relatives au «biobanking» (ISO
20387:2018)
Ta slovenski standard je istoveten z: EN ISO 20387:2020
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
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2020
ICS 07.080
English version
Biotechnology - Biobanking - General requirements for
biobanking (ISO 20387:2018)
Biotechnologie - "Biobanking" - Exigences générales Biotechnologie - Biobanking - Allgemeine
relatives au "biobanking" (ISO 20387:2018) Anforderungen an Biobanking (ISO 20387:2018)
This European Standard was approved by CEN on 31 August 2020.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a 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 European Standard 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, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2020 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 20387:2020 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 20387:2018 has been prepared by Technical Committee ISO/TC 276 "Biotechnology” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 20387:2020
by Technical Committee CEN/CLC/JTC 1 “Criteria for conformity assessment bodies” the secretariat of
which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2021, and conflicting national standards shall
be withdrawn at the latest by March 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20387:2018 has been approved by CEN as EN ISO 20387:2020 without any modification.
INTERNATIONAL ISO
STANDARD 20387
First edition
2018-08
Biotechnology — Biobanking —
General requirements for biobanking
Biotechnologie — «Biobanking» — Exigences générales relatives au
«biobanking»
Reference number
ISO 20387:2018(E)
©
ISO 2018
ISO 20387:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 20387:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 8
4.1 General . 8
4.2 Impartiality . 9
4.3 Confidentiality . 9
5 Structural requirements . 9
6 Resource requirements .10
6.1 General .10
6.2 Personnel .11
6.2.1 General.11
6.2.2 Competence and competence assessment .11
6.2.3 Training .11
6.3 Facilities/dedicated areas and environmental conditions .12
6.4 Externally provided processes, products and services .12
6.5 Equipment .13
7 Process requirements .14
7.1 General .14
7.2 Collection of biological material and associated data .15
7.2.1 Documented information requirements .15
7.2.2 Pre-acquisition information .15
7.2.3 Collection procedure .15
7.3 Reception and distribution of biological material and associated data.15
7.3.1 Access principles .15
7.3.2 Reception .15
7.3.3 Distribution .16
7.4 Transport of biological material and associated data .16
7.5 Traceability of biological material and associated data .17
7.6 Preparation and preservation of biological material .18
7.7 Storage of biological material .18
7.8 Quality control of biological material and associated data .19
7.8.1 General.19
7.8.2 Quality control of processes .19
7.8.3 Quality control of data .20
7.9 Validation and verification of methods .20
7.9.1 General.20
7.9.2 Validation .20
7.9.3 Verification .20
7.10 Management of information and data .21
7.11 Nonconforming output .21
7.11.1 General.21
7.11.2 Control of nonconforming output .22
7.12 Report requirements .22
7.12.1 General.22
7.12.2 Content of the report .
...
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