ISO 21899:2020

Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks

This document specifies the validation and verification requirements applicable to a biobank to be able to demonstrate that it operates its processing of biological materials with validated and/or verified methods that are fit for purpose. This document is intended for use in the implementation and validation of processing methods for biological materials. This document covers method validation and verification for the production of all biological materials. This document does not apply to biological material intended for food/feed production, laboratories undertaking food/feed analysis, and/or therapeutic use. Reference material production is not covered in this document. For the production requirements for reference materials, see ISO 17034.

Biotechnologie — Biobanques — Exigences générales pour la validation et la vérification des méthodes de traitement du matériel biologique dans les biobanques

Le présent document spécifie les exigences de validation et de vérification applicables pour qu'une biobanque puisse démontrer qu'elle réalise le traitement des matériels biologiques selon des méthodes validées et/ou vérifiées qui sont adéquates à l'usage prévu. Le présent document est destiné à être utilisé pour la mise en place et la validation des méthodes de traitement des matériels biologiques. Le présent document couvre la validation et la vérification des méthodes de production de tous les matériels biologiques. 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 de denrées alimentaires/d'aliments pour animaux et/ou à un usage thérapeutique. La production de matériaux de référence n'est pas couverte par le présent document. Pour les exigences liées à la production des matériaux de référence, voir l'ISO 17034.

General Information

• Status: Published
• Publication Date: 14-Jun-2020
• ICS: 07.080 - Biology. Botany. Zoology
• Technical Committee: ISO/TC 276 - Biotechnology
• Drafting Committee: ISO/TC 276/WG 2 - Biobanks and bioresources
• Current Stage: 6060 - International Standard published
• Start Date: 15-Jun-2020
• Due Date: 20-Jul-2020
• Completion Date: 15-Jun-2020

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 21899
First edition
2020-06
Biotechnology — Biobanking —
General requirements for the
validation and verification of
processing methods for biological
material in biobanks
Biotechnologie — Biobanques — Exigences générales pour la
validation et la vérification des méthodes de traitement du matériel
biologique dans les biobanques
Reference number
ISO 21899:2020(E)
©
ISO 2020

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ISO 21899:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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ISO 21899:2020(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 5
5 General and resource requirements . 6
6 Selection of processing methods . 6
7 Processing method implementation . 7
7.1 Targets for method implementation . 7
7.2 Processing method implementation . 7
8 Initial validation of a processing method . 7
8.1 General . 7
8.2 Validation plan . 8
8.3 Assays for properties of interest . 8
8.4 Validation execution . 9
8.4.1 General. 9
8.4.2 Validation site . 9
8.4.3 In-house or outsourced testing . 9
8.5 Targets for processing method validation .10
8.5.1 General.10
8.5.2 Fitness for purpose .10
8.5.3 Reproducibility .10
8.5.4 Robustness .10
8.5.5 Homogeneity .11
8.5.6 Stability .11
8.6 Review and approval of validation report .12
9 Further validation .12
10 Method verification .12
11 Ongoing monitoring of a processing method.13
11.1 General .13
11.2 Frequency of the monitoring .13
11.3 Planning .14
11.4 Procedure of the systematic monitoring .14
11.5 Procedure of the periodic monitoring .14
11.6 External quality assessments (EQA)/Interlaboratory exercises .15
12 Record keeping and archiving .15
Annex A (informative) Processing and testing methods .16
Annex B (informative) Examples of validation plans .17
Bibliography .20
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ISO 21899:2020(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

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ISO 21899:2020(E)

Introduction
Biobanks, producing viable and non-viable biological materials (human, animal, plant, microbial) for
research purposes, within biotechnology, use processing methods. Many biobanks include processing
laboratories where processing methods are performed and biological materials are produced as an
output. Examples of widely used processing methods, applied by biobank laboratories, include DNA,
RNA and protein extractions from blood, tissue, seeds, bacteria, or other biological material, or primary
cell cultures. An example for the validation of a processing method is provided in Reference [27].
Biobank laboratories are not always equipped to perform testing methods, which are required for
annotation or qualification of the biological material output.
This document sets out specific requirements for validation of processing methods. It is intended to
help biobank laboratories who perform processing of biological materials, whether they perform
themselves testing activities on the biological materials they have produced, or not. It enables validation
of processing methods, complements the quality management system of any biobank laboratory
performing processing of biological materials and gives more credibility to such an organization. It
is understood that while the term “method” used in ISO/IEC 17025 corresponds to “testing method”
or “calibration method”, a fundamental distinction exists between “processing methods” where the
output is a biological material and “testing methods” where the output is a test result (see Annex A). It
is understood that validation of processing methods performed by accredited testing laboratories, who
test the biological material output themselves, is already included in their accreditation scope.
Validation of a processing method encompasses confirmation of the fitness for purpose of the output
biological material, assessment of the homogeneity and stability of the biological material, and
assessment of the reproducibility and robustness of the processing method. This validation requires
testing in order to assess/measure the qualitative or quantitative properties of the biological material.
This testing will lead to the assessment of the fitness for purpose, the reproducibility, and the robustness
of the processing method. Examples of such properties are: viability, purity, pluripotency, molecular
integrity, concentration, growth capacity, etc.
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INTERNATIONAL STANDARD ISO 21899:2020(E)
Biotechnology — Biobanking — General requirements for
the validation and verification of processing methods for
biological material in biobanks
1 Scope
This document specifies the validation and verification requirements applicable to a biobank to be able
to demonstrate that it operates its processing of biological materials with validated and/or verified
methods that are fit for purpose.
This document is intended for use in the implementation and validation of processing methods for
biological materials.
This document covers method validation and verification for the production of all biological materials.
This document does not apply to biological material intended for food/feed production, laboratories
undertaking food/feed analysis, and/or therapeutic use.
Reference material production is not covered in this document. For the production requirements for
reference materials, see ISO 17034.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 20387, Biotechnology — Biobanking — General requirements for biobanking
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 20387 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
aliquot
portion of a quantity of biological material which has been divided into separate parts at the same time
under identical conditions
Note 1 to entry: The aliquot is representative of the biological material with respect to the property or properties
being investigated.
Note 2 to entry: The term aliquot most commonly refers to liquid or semi-liquid biological materials.
3.2
biobank laboratory
processing (3.15) laboratory under the control of a biobank where processing methods (3.16) are
performed for the output/production of biological materials
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ISO 21899:2020(E)

3.3
exploratory processing method
processing method (3.16) or adaptation/modification of a processing method, at an early stage of
development by the biobank laboratory (3.2) and for which further assessment is needed to determine if
it is useful for a specified application
3.4
external provider
body that undertakes aspects of the collection, transportation, preparation (3.14), handling,
homogeneity (3.7) and stability (3.21) assessment, testing or storage of the biological materials under
its own management system, on behalf of the biobank, on a contractual basis, or in the context of the
validation (3.25) of a processing method (3.16)
Note 1 to entry: A body can be an organization or a company, public or private.
3.5
feasibility
assessment of whether the processing method (3.16) can be applied to produce the desired type of
biological material output, independently from the properties of interest of this output biological
material
3.6
fit for purpose
fitness for the intended purpose
in-line with prearranged requirements for an intended use
Note 1 to entry: The definition of such requirements can take place within the biobank itself and/or in
collaboration with users and should consider analytical and other relevant criteria.
Note 2 to entry: These requirements correspond to the feasibility (3.5) of the downstream intended use and the
satisfaction of predefined performance (3.12) criteria of the intended use.
[SOURCE: ISO 20387:2018, 3.24, modified — Note 2 to entry has been added.]
3.7
homogeneity
uniformity of a specified, quantitative or qualitative, property value throughout a defined portion [or
among different aliquots (3.1)] of a biological material
3.8
installation qualification
IQ
process of establishing by objective evidence that all key aspects of the process equipment and ancillary
system installation comply with the approved specification
[SOURCE: ISO 11139:2018, 3.220.2]
3.9
measurand
quantity intended to be measured
[SOURCE: ISO/IEC Guide 99:2007, 2.3, modified — Notes to entry and examples were deleted.]
3.10
measurement
process of experimentally obtaining one or more quantity values that can reasonably be attributed to a
quantity
Note 1 to entry: Measurement does not apply to nominal properties.
Note 2 to entry: Measurement implies comparison of quantities or counting of entities.
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ISO 21899:2020(E)

Note 3 to entry: Measurement presupposes a description of the quantity commensurate with the intended use of
a measurement result, a measurement procedure, and a calibrated measuring system operating according to the
specified measurement procedure, including the measurement conditions
[SOURCE: ISO/IEC Guide 99:2007, 2.1]
3.11
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined
limits when used in accordance with its operational procedures
[SOURCE: ISO 11139:2018, 3.220.3]
3.12
performance
set of properties of interest of a biological material, produced by a processing method (3.16), e.g. yield,
purity, integrity, viability, functionality
3.13
performance qualification
PQ
process of establishing by objective evidence that the process, under anticipated conditions, consistently
produces a product which meets all predetermined requirements
[SOURCE: ISO 11139:2018, 3.220.4]
3.14
preparation
activities, taking place in a laboratory after acquisitioning, to make biological material ready for further
use in the life cycle, storage or distribution
Note 1 to entry: These activities can include, e.g. determination of volume or weight, centrifugation,
homogenization, purification, isolation, fixation, stabilization, filtration, sorting, culture, vacuum drying, freeze
drying, fractionation, aliquoting, removing tissues, cutting / milling / shaping, washing / soaking with antibiotic
or antimicrobial solutions, volume reduction / concentration, demineralization, glycerolisation, sterilization,
controlled or uncontrolled freezing, vitrification, cryopreservation.
[SOURCE: ISO 20387:2018, 3.37, modified — Note 1 to entry was modified by adding more details.]
3.15
processing
performing any activity on biological material and associated data during all stages of the life cycle
[SOURCE: ISO 20387:2018, 3.36]
3.16
processing method
procedure, applied to biological material and/or associated data during processing (3.15), with potential
to impact the intrinsic properties of the biological material and/or associated data produced as output
Note 1 to entry: A processing method can include, but is not limited to, activities belonging to: collection,
preparation (3.14), preservation, storage.
Note 2 to entry: The whole or part of a processing method can be a standard method.
Note 3 to entry: The term “standard” in this instance refers to the broader definition of “standard” — i.e., an
agreed-upon set of requirements.
Note 4 to entry: A simple processing method is a processing method that requires a simple laboratory
manipulation (e.g. centrifugation of collection tubes or mechanical disruption of tissues) without the addition of
chemical substances by the biobank laboratory (3.2) operator, and without cell disruption or cell selection as part
of a multi-step process (e.g. preparation of plasma, serum, buffy coat).
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ISO 21899:2020(E)

Note 5 to entry: A complex processing method is a processing method that requires usage of multiple steps and/
or addition of chemical substances by the biobank laboratory operator (e.g. preparation of DNA, RNA, proteins,
nuclei and other organelles, cell lines).
Note 6 to entry: Qualitative or quantitative tests for the examination of properties/quality/quantity attributes of
the produced biological material are outside of the scope of the “processing method” itself. However, a qualitative
or quantitative test can be part of a “processing method” if it is necessary as an “in-process control” step during
the processing method.
[SOURCE: ISO 20387:2018, 3.38, modified — The notes to entry were added.]
3.17
proficiency testing
evaluation of participant performance (3.12) against pre-established criteria by means of interlaboratory
comparisons
[SOURCE: ISO/IEC 17043:2010, 3.7, modified — Notes to entry have been deleted.]
3.18
property of interest
physical, chemical, biological, or microbiological property or characteristic that describes or is an
indicator of quality
3.19
reproducibility
coefficient of variation (CV %) of a property value being measured in biological
materials which are the processing (3.15) output from aliquots (3.1) of the same input biological material
(e.g. volume, weight, concentration)
Note 1 to entry: The reproducibility of a processing method (3.16) includes components arising from the processing
method itself and from the analytical uncertainty of the testing method used to assess the reproducibility.
Note 2 to entry: In general, for a given set of information, it is understood that the reproducibility of a processing
method is associated with a stated measurand (3.9). A modification of this measurand and the testing method
results in a modification of the associated reproducibility.
3.20
robustness
capacity of a processing method (3.16) to produce biological materials whose
properties remain within defined limits despite deviations from the experimental conditions that are
described in the standard operating procedure (SOP) (3.22) of the processing method
3.21
stability
ability of a biological material, when stored under specified conditions, to maintain a specified property
value within specified limits for a specified period of time
[SOURCE: ISO Guide 30:2015, 2.1.15, modified — The words “reference material” have been replaced by
“biological material" and Note 1 to entry has been deleted.]
3.22
standard operating procedure
SOP
written procedure prescribed for repetitive use as a practice, in accordance with agreed-upon
specifications aimed at obtaining a desired outcome
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ISO 21899:2020(E)

3.23
standard processing method
method officially accepted and recognized described in unambiguous details and validated for a
stated purpose
Note 1 to entry: Standard processing methods include e.g. methods published by a standardization body or
approved by regulatory authorities or published in peer-reviewed scientific literature, dedicated, at least partly,
to the validation (3.25) of the method.
Note 2 to entry: The term “standard” in this instance refers to the broader definition of “standard”—i.e., an
agreed-upon set of requirements.
3.24
stress
intentional exposure of biological material to conditions that are different from the predefined routine
conditions or procedures and that can affect the properties of the biological material
3.25
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended
use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination
such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word "validated" is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
Note 4 to entry: Validation is the confirmation that the specifications announced by the biobank laboratory (3.2)
are met.
[SOURCE: ISO 9000:2015, 3.8.13, modified — Note 4 to entry was added.]
3.26
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled
Note 1 to entry: Verification is the confirmation that the specifications announced by a supplier, a publication or
another external source are met.
Note 2 to entry: The objective evidence needed for a verification can be the result of an inspection or of other
forms of determination such as performing alternative calculations or reviewing documents.
Note 3 to entry: The activities carried out for verification are sometimes called a qualification process.
Note 4 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO 9000:2015, 3.8.12, modified — Note 1 to entry was added.]
4 Abbreviated terms
Abbreviated term Explanation
CPT cell preparation tube
CV coefficient of variation
Hly hemolysin
n number of samples
M mean square
OD optical density
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ISO 21899:2020(E)

Abbreviated term Explanation
PBMC peripheral blood mononuclear cells
PCA principal component analysis
RT room temperature
u variance
S standard deviation
SOP standard operating procedure
5 General and resource requirements
The biobank shall establish, implement and maintain a documented quality management system. (See
e.g. ISO 9001 or ISO 20387:2018, Clause 8.)
Requirements relative to personnel, infrastructure and environmental conditions, and processing
equipment are described in ISO 20387 and shall be followed.
6 Selection of processing methods
6.1 The methods for processing of biological materials shall meet the specified requirements for the
intended use and/or the needs of the customer (depositor or recipient). When the intended use is not
known beforehand, the biobank laboratory shall define a perimeter of intended uses (e.g. DNA-based tests).
6.1.1 When the customer (depositor or recipient) does not specify the processing method to be used,
the biobank laboratory shall select processing methods that have been published either in international,
regional or national standards, or by reputable technical organizations, or in relevant scientific texts or
journals, or as specified by the manufacturer of the equipment / commercial kit, and that are deemed fit
for purpose.
6.1.2 The biobank laboratory shall ensure that it uses the latest valid edition of a standard and/or
user manual, unless it is not appropriate or feasible to do so. Whenever necessary, the standard shall be
supplemented with additional details to ensure consistent application.
6.2 Biobank laboratory-developed methods or methods adopted by the biobank laboratory can also
be used if they are appropriate for the intended use and are validated. The customer shall be informed,
upon their request, as to the specifications of the method chosen, which constitute critical elements of
the method, and as to the scope of its validation by the biobank laboratory.
When a customer requests implementation of an exploratory processing method, or the implementation
of a method of processing for rare biological material types, the customer can accept that the method
is not validated or that the method is validated using surrogate materials. Such acceptance shall be
documented. If any report based on an exploratory processing method or methods that otherwise lack
conclusive validation evidence is issued by the biobank, the lack of assurance of its fitness for purpose
and the acceptance of the processing method by the client shall be stated.
6.3 The biobank shall inform the customer when the method proposed by the customer is considered
to be inappropriate for the intended use or out of date.
6.4 A description and the performance specifications of the selected processing methods shall be
documented.
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...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 21899
ISO/TC 276
Biotechnology — Biobanking —
Secretariat: DIN
General requirements for the
Voting begins on:
2020­03­10 validation and verification of
processing methods for biological
Voting terminates on:
2020­05­05
material in biobanks
Biotechnologie — Biobanques — Exigences générales pour la
validation et la vérification des méthodes de traitement du matériel
biologique dans les biobanques
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 21899:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2020

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ISO/FDIS 21899:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH­1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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ISO/FDIS 21899:2020(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 5
5 General and resource requirements . 6
6 Selection of processing methods . 6
7 Processing method implementation . 7
7.1 Targets for method implementation . 7
7.2 Processing method implementation . 7
8 Initial validation of a processing method . 7
8.1 General . 7
8.2 Validation plan . 8
8.3 Assays for properties of interest . 8
8.4 Validation execution . 9
8.4.1 General. 9
8.4.2 Validation site . 9
8.4.3 In­house or outsourced testing . 9
8.5 Targets for processing method validation .10
8.5.1 General.10
8.5.2 Fitness for purpose .10
8.5.3 Reproducibility .10
8.5.4 Robustness .10
8.5.5 Homogeneity .11
8.5.6 Stability .11
8.6 Review and approval of validation report .12
9 Further validation .12
10 Method verification .12
11 Ongoing monitoring of a processing method.13
11.1 General .13
11.2 Frequency of the monitoring .13
11.3 Planning .14
11.4 Procedure of the systematic monitoring .14
11.5 Procedure of the periodic monitoring .14
11.6 External quality assessments (EQA)/Interlaboratory exercises .15
12 Record keeping and archiving .15
Annex A (informative) Processing and testing methods .16
Annex B (informative) Examples of validation plans .17
Bibliography .20
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ISO/FDIS 21899:2020(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non­governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

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ISO/FDIS 21899:2020(E)

Introduction
Biobanks, producing viable and non­viable biological materials (human, animal, plant, microbial) for
research purposes, within biotechnology, use processing methods. Many biobanks include processing
laboratories where processing methods are performed and biological materials are produced as an
output. Examples of widely used processing methods, applied by biobank laboratories, include DNA,
RNA and protein extractions from blood, tissue, seeds, bacteria, or other biological material, or primary
cell cultures. An example for the validation of a processing method is provided in Reference [27].
Biobank laboratories are not always equipped to perform testing methods, which are required for
annotation or qualification of the biological material output.
This document sets out specific requirements for validation of processing methods. It is intended to
help biobank laboratories who perform processing of biological materials, whether they perform
themselves testing activities on the biological materials they have produced, or not. It enables validation
of processing methods, complements the quality management system of any biobank laboratory
performing processing of biological materials and gives more credibility to such an organization. It
is understood that while the term “method” used in ISO/IEC 17025 corresponds to “testing method”
or “calibration method”, a fundamental distinction exists between “processing methods” where the
output is a biological material and “testing methods” where the output is a test result (see Annex A). It
is understood that validation of processing methods performed by accredited testing laboratories, who
test the biological material output themselves, is already included in their accreditation scope.
Validation of a processing method encompasses confirmation of the fitness for purpose of the output
biological material, assessment of the homogeneity and stability of the biological material, and
assessment of the reproducibility and robustness of the processing method. This validation requires
testing in order to assess/measure the qualitative or quantitative properties of the biological material.
This testing will lead to the assessment of the fitness for purpose, the reproducibility, and the robustness
of the processing method. Examples of such properties are: viability, purity, pluripotency, molecular
integrity, concentration, growth capacity, etc.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 21899:2020(E)
Biotechnology — Biobanking — General requirements for
the validation and verification of processing methods for
biological material in biobanks
1 Scope
This document specifies the validation and verification requirements applicable to a biobank to be able
to demonstrate that it operates its processing of biological materials with validated and/or verified
methods that are fit for purpose.
This document is intended for use in the implementation and validation of processing methods for
biological materials.
This document covers method validation and verification for the production of all biological materials.
This document does not apply to biological material intended for food/feed production, laboratories
undertaking food/feed analysis, and/or therapeutic use.
Reference material production is not covered in this document. For the production requirements for
reference materials, see ISO 17034.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 20387, Biotechnology — Biobanking — General requirements for biobanking
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 20387 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
aliquot
portion of a quantity of biological material which has been divided into separate parts at the same time
under identical conditions
Note 1 to entry: The aliquot is representative of the biological material with respect to the property or properties
being investigated.
Note 2 to entry: The term aliquot most commonly refers to liquid or semi-liquid biological materials.
3.2
biobank laboratory
processing (3.15) laboratory under the control of a biobank where processing methods (3.16) are
performed for the output/production of biological materials
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3.3
exploratory processing method
processing method (3.16) or adaptation/modification of a processing method, at an early stage of
development by the biobank laboratory (3.2) and for which further assessment is needed to determine if
it is useful for a specified application
3.4
external provider
body that undertakes aspects of the collection, transportation, preparation (3.14), handling,
homogeneity (3.7) and stability (3.21) assessment, testing or storage of the biological materials under
its own management system, on behalf of the biobank, on a contractual basis, or in the context of the
validation (3.25) of a processing method (3.16)
Note 1 to entry: A body can be an organization or a company, public or private.
3.5
feasibility
assessment of whether the processing method (3.16) can be applied to produce the desired type of
biological material output, independently from the properties of interest of this output biological
material
3.6
fit for purpose
fitness for the intended purpose
in-line with prearranged requirements for an intended use
Note 1 to entry: The definition of such requirements can take place within the biobank itself and/or in
collaboration with users and should consider analytical and other relevant criteria.
Note 2 to entry: These requirements correspond to the feasibility (3.5) of the downstream intended use and the
satisfaction of predefined performance (3.12) criteria of the intended use.
[SOURCE: ISO 20387:2018, 3.24, modified — Note 2 to entry has been added.]
3.7
homogeneity
uniformity of a specified, quantitative or qualitative, property value throughout a defined portion [or
among different aliquots (3.1)] of a biological material
3.8
installation qualification
IQ
process of establishing by objective evidence that all key aspects of the process equipment and ancillary
system installation comply with the approved specification
[SOURCE: ISO 11139:2018, 3.220.2]
3.9
measurand
quantity intended to be measured
[SOURCE: ISO/IEC Guide 99:2007, 2.3, modified — Notes to entry and examples were deleted.]
3.10
measurement
process of experimentally obtaining one or more quantity values that can reasonably be attributed to a
quantity
Note 1 to entry: Measurement does not apply to nominal properties.
Note 2 to entry: Measurement implies comparison of quantities or counting of entities.
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Note 3 to entry: Measurement presupposes a description of the quantity commensurate with the intended use of
a measurement result, a measurement procedure, and a calibrated measuring system operating according to the
specified measurement procedure, including the measurement conditions
[SOURCE: ISO/IEC Guide 99:2007, 2.1]
3.11
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined
limits when used in accordance with its operational procedures
[SOURCE: ISO 11139:2018, 3.220.3]
3.12
performance
set of properties of interest of a biological material, produced by a processing method (3.16), e.g. yield,
purity, integrity, viability, functionality
3.13
performance qualification
PQ
process of establishing by objective evidence that the process, under anticipated conditions, consistently
produces a product which meets all predetermined requirements
[SOURCE: ISO 11139:2018, 3.220.4]
3.14
preparation
activities, taking place in a laboratory after acquisitioning, to make biological material ready for further
use in the life cycle, storage or distribution
Note 1 to entry: These activities can include, e.g. determination of volume or weight, centrifugation,
homogenization, purification, isolation, fixation, stabilization, filtration, sorting, culture, vacuum drying, freeze
drying, fractionation, aliquoting, removing tissues, cutting / milling / shaping, washing / soaking with antibiotic
or antimicrobial solutions, volume reduction / concentration, demineralization, glycerolisation, sterilization,
controlled or uncontrolled freezing, vitrification, cryopreservation.
[SOURCE: ISO 20387:2018, 3.37, modified — Note 1 to entry was modified by adding more details.]
3.15
processing
performing any activity on biological material and associated data during all stages of the life cycle
[SOURCE: ISO 20387:2018, 3.36]
3.16
processing method
procedure, applied to biological material and/or associated data during processing (3.15), with potential
to impact the intrinsic properties of the biological material and/or associated data produced as output
Note 1 to entry: A processing method can include, but is not limited to, activities belonging to: collection,
preparation (3.14), preservation, storage.
Note 2 to entry: The whole or part of a processing method can be a standard method.
Note 3 to entry: The term “standard” in this instance refers to the broader definition of “standard” — i.e., an
agreed-upon set of requirements.
Note 4 to entry: A simple processing method is a processing method that requires a simple laboratory
manipulation (e.g. centrifugation of collection tubes or mechanical disruption of tissues) without the addition of
chemical substances by the biobank laboratory (3.2) operator, and without cell disruption or cell selection as part
of a multi-step process (e.g. preparation of plasma, serum, buffy coat).
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Note 5 to entry: A complex processing method is a processing method that requires usage of multiple steps and/
or addition of chemical substances by the biobank laboratory operator (e.g. preparation of DNA, RNA, proteins,
nuclei and other organelles, cell lines).
Note 6 to entry: Qualitative or quantitative tests for the examination of properties/quality/quantity attributes of
the produced biological material are outside of the scope of the “processing method” itself. However, a qualitative
or quantitative test can be part of a “processing method” if it is necessary as an “in-process control” step during
the processing method.
[SOURCE: ISO 20387:2018, 3.38, modified — The notes to entry were added.]
3.17
proficiency testing
evaluation of participant performance (3.12) against pre-established criteria by means of interlaboratory
comparisons
[SOURCE: ISO/IEC 17043:2010, 3.7, modified — Notes to entry have been deleted.]
3.18
property of interest
physical, chemical, biological, or microbiological property or characteristic that describes or is an
indicator of quality
3.19
reproducibility
coefficient of variation (CV %) of a property value being measured in biological
materials which are the processing (3.15) output from aliquots (3.1) of the same input biological material
(e.g. volume, weight, concentration)
Note 1 to entry: The reproducibility of a processing method (3.16) includes components arising from the processing
method itself and from the analytical uncertainty of the testing method used to assess the reproducibility.
Note 2 to entry: In general, for a given set of information, it is understood that the reproducibility of a processing
method is associated with a stated measurand (3.9). A modification of this measurand and the testing method
results in a modification of the associated reproducibility.
3.20
robustness
capacity of a processing method (3.16) to produce biological materials whose
properties remain within defined limits despite deviations from the experimental conditions that are
described in the standard operating procedure (SOP) (3.22) of the processing method
3.21
stability
ability of a biological material, when stored under specified conditions, to maintain a specified property
value within specified limits for a specified period of time
[SOURCE: ISO Guide 30:2015, 2.1.15, modified — The words “reference material” have been replaced by
“biological material" and Note 1 to entry has been deleted.]
3.22
standard operating procedure
SOP
written procedure prescribed for repetitive use as a practice, in accordance with agreed­upon
specifications aimed at obtaining a desired outcome
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3.23
standard processing method
method officially accepted and recognized described in unambiguous details and validated for a
stated purpose
Note 1 to entry: Note to entry 1: Standard processing methods include e.g. methods published by a standardization
body or approved by regulatory authorities or published in peer-reviewed scientific literature, dedicated, at least
partly, to the validation (3.25) of the method.
Note 2 to entry: Note to entry 2: The term “standard” in this instance refers to the broader definition of
“standard”—i.e., an agreed-upon set of requirements.
3.24
stress
intentional exposure of biological material to conditions that are different from the predefined routine
conditions or procedures and that can affect the properties of the biological material
3.25
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended
use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination
such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word "validated" is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
Note 4 to entry: Validation is the confirmation that the specifications announced by the biobank laboratory (3.2)
are met.
[SOURCE: ISO 9000:2015, 3.8.13, modified — Note 4 to entry was added.]
3.26
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled
Note 1 to entry: Verification is the confirmation that the specifications announced by a supplier, a publication or
another external source are met.
Note 2 to entry: The objective evidence needed for a verification can be the result of an inspection or of other
forms of determination such as performing alternative calculations or reviewing documents.
Note 3 to entry: The activities carried out for verification are sometimes called a qualification process.
Note 4 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO 9000:2015, 3.8.12, modified — Note 1 to entry was added.]
4 Abbreviations
Abbreviation Explanation
CPT cell preparation tube
CV coefficient of variation
Hly hemolysin
n number of samples
M mean square
OD optical density
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Abbreviation Explanation
PBMC peripheral blood mononuclear cells
PCA principal component analysis
RT room temperature
u variance
S standard deviation
SOP standard operating procedure
5 General and resource requirements
The biobank shall establish, implement and maintain a documented quality management system. (See
e.g. ISO 9001 or ISO 20387:2018, Clause 8.)
Requirements relative to personnel, infrastructure and environmental conditions, and processing
equipment are described in ISO 20387 and shall be followed.
6 Selection of processing methods
6.1 The methods for processing of biological materials shall meet the specified requirements for the
intended use and/or the needs of the customer (depositor or recipient). When the intended use is not
known beforehand, the biobank laboratory shall define a perimeter of intended uses (e.g. DNA-based tests).
6.1.1 When the customer (depositor or recipient) does not specify the processing method to be used,
the biobank laboratory shall select processing methods that have been published either in international,
regional or national standards, or by reputable technical organizations, or in relevant scientific texts or
journals, or as specified by the manufacturer of the equipment / commercial kit, and that are deemed fit
for purpose.
6.1.2 The biobank laboratory shall ensure that it uses the latest valid edition of a standard and/or
user manual, unless it is not appropriate or feasible to do so. Whenever necessary, the standard shall be
supplemented with additional details to ensure consistent application.
6.2 Biobank laboratory-developed methods or methods adopted by the biobank laboratory can also
be used if they are appropriate for the intended use and are validated. The customer shall be informed,
upon their request, as to the specifications of the method chosen, which constitute critical elements of
the method, and as to the scope of its validation by the biobank laboratory.
When a customer requests implementation of an exploratory processing method, or the implementation
of a method of processing for rare biological material types, the customer can accept that the method
is not validated or that the method is validated using sur
...

NORME ISO
INTERNATIONALE 21899
Première édition
2020-06
Biotechnologie — Biobanques —
Exigences générales pour la validation
et la vérification des méthodes de
traitement du matériel biologique
dans les biobanques
Biotechnology — Biobanking — General requirements for the
validation and verification of processing methods for biological
material in biobanks
Numéro de référence
ISO 21899:2020(F)
©
ISO 2020

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ISO 21899:2020(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
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Publié en Suisse
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ISO 21899:2020(F)

Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Termes abrégés . 6
5 Généralités et exigences relatives aux ressources . 6
6 Sélection des méthodes de traitement . 6
7 Mise en place d’une méthode de traitement . 7
7.1 Objectifs de la mise en place d’une méthode . 7
7.2 Mise en place d’une méthode de traitement . 7
8 Validation initiale d’une méthode de traitement . 8
8.1 Généralités . 8
8.2 Plan de validation . 8
8.3 Analyses des propriétés d’intérêt . 9
8.4 Exécution de la validation . 9
8.4.1 Généralités . 9
8.4.2 Site de validation . 9
8.4.3 Essais internes ou externalisés . 9
8.5 Objectifs de la validation d’une méthode de traitement .10
8.5.1 Généralités .10
8.5.2 Adéquation à l’usage prévu .10
8.5.3 Reproductibilité .11
8.5.4 Robustesse .11
8.5.5 Homogénéité .12
8.5.6 Stabilité .12
8.6 Revue et approbation du rapport de validation .13
9 Validation plus approfondie .13
10 Vérification de la méthode .13
11 Surveillance continue d’une méthode de traitement .14
11.1 Généralités .14
11.2 Fréquence de la surveillance . .14
11.3 Planification .15
11.4 Procédure de surveillance systématique.15
11.5 Procédure de surveillance périodique.15
11.6 Évaluations externes de la qualité (EQA)/exercices interlaboratoires .16
12 Conservation des enregistrements et archivage .16
Annexe A (informative) Méthodes de traitement et d’essai .17
Annexe B (informative) Exemples de plans de validation .18
Bibliographie .21
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ISO 21899:2020(F)

Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.
L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www
.iso .org/ directives).
L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de
brevets reçues par l'ISO (voir www .iso .org/ brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion
de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir www .iso .org/ avant -propos.
Le présent document a été élaboré par le comité technique ISO/TC 276, Biotechnologie.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www .iso .org/ fr/ members .html.
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ISO 21899:2020(F)

Introduction
Les biobanques, qui gèrent des matériels biologiques viables et non viables (d’origine humaine, animale,
végétale, microbienne) pour la recherche dans le cadre de la biotechnologie, utilisent des méthodes de
traitement. De nombreuses biobanques abritent des laboratoires de traitement qui mettent en œuvre
ces méthodes de traitement et qui produisent des matériels biologiques en sortie. Comme exemples de
méthodes de traitement largement utilisées, appliquées par les laboratoires des biobanques, on peut
citer l’extraction d’ADN, d’ARN et de protéines à partir du sang, des tissus, des semences, des bactéries
ou d’autres matériels biologiques, ou les cultures de cellules primaires. Un exemple de validation d’une
méthode de traitement est fourni dans la Référence [27]. Les laboratoires des biobanques ne sont
pas toujours équipés pour mettre en œuvre les méthodes d’essai nécessaires à l’annotation ou à la
qualification des matériels biologiques obtenus.
Le présent document définit les exigences spécifiques relatives à la validation des méthodes de
traitement. Il est destiné à aider les laboratoires des biobanques qui effectuent le traitement de
matériels biologiques, qu’ils effectuent ou non eux-mêmes les activités d’essai des matériels biologiques
qu’ils ont produits. Il permet de réaliser la validation des méthodes de traitement et de compléter
le système de management de la qualité de tout laboratoire de biobanque effectuant le traitement
de matériels biologiques, donnant ainsi plus de crédibilité à cette organisation. Il est entendu que si
le terme « méthode » utilisé dans l’ISO/IEC 17025 désigne une « méthode d’essai » ou une « méthode
d’étalonnage », il existe une distinction fondamentale entre les « méthodes de traitement », pour
lesquelles l’élément de sortie est un matériel biologique, et les « méthodes d’essai », pour lesquelles
l’élément de sortie est un résultat d’essai (voir l’Annexe A). Il est entendu que la validation des méthodes
de traitement mises en œuvre par les laboratoires d’essais accrédités, qui soumettent eux-mêmes à
essai les matériels biologiques obtenus, est déjà comprise dans leur domaine d’accréditation.
La validation d’une méthode de traitement comprend la confirmation de l’adéquation à l’usage prévu des
matériels biologiques obtenus, l’évaluation de l’homogénéité et de la stabilité des matériels biologiques
et l’évaluation de la reproductibilité et de la robustesse de la méthode de traitement. Cette validation
nécessite des essais visant à évaluer/mesurer les propriétés qualitatives ou quantitatives des matériels
biologiques. Ces essais permettront d’évaluer l’adéquation à l’usage prévu, la reproductibilité et la
robustesse de la méthode de traitement. Exemples de ces propriétés: viabilité, pureté, pluripotence,
intégrité moléculaire, concentration, capacité de croissance, etc.
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NORME INTERNATIONALE ISO 21899:2020(F)
Biotechnologie — Biobanques — Exigences générales pour
la validation et la vérification des méthodes de traitement
du matériel biologique dans les biobanques
1 Domaine d’application
Le présent document spécifie les exigences de validation et de vérification applicables pour qu’une
biobanque puisse démontrer qu’elle réalise le traitement des matériels biologiques selon des méthodes
validées et/ou vérifiées qui sont adéquates à l’usage prévu.
Le présent document est destiné à être utilisé pour la mise en place et la validation des méthodes de
traitement des matériels biologiques.
Le présent document couvre la validation et la vérification des méthodes de production de tous les
matériels biologiques. 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
de denrées alimentaires/d’aliments pour animaux et/ou à un usage thérapeutique.
La production de matériaux de référence n’est pas couverte par le présent document. Pour les exigences
liées à la production des matériaux de référence, voir l’ISO 17034.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.
Pour les références non datées, la dernière édition du document de référence s'applique (y compris les
éventuels amendements).
ISO 20387, Biotechnologie — «Biobanking» — Exigences générales relatives au «biobanking»
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions donnés dans l’ISO 20387 ainsi que les
suivants, s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
3.1
aliquote
portion d’une quantité de matériel biologique qui a été divisée en plusieurs parties, en même temps,
dans des conditions identiques
Note 1 à l'article: L’aliquote est représentative du matériel biologique pour la ou les propriétés étudiées.
Note 2 à l'article: Le terme «aliquote» fait communément référence à des matériels biologiques liquides ou semi-
liquides.
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ISO 21899:2020(F)

3.2
laboratoire d’une biobanque
laboratoire de traitement (3.15) sous le contrôle d’une biobanque, dans lequel des méthodes de traitement
(3.16) sont mises en œuvre pour obtenir/produire des matériels biologiques
3.3
méthode de traitement exploratoire
méthode de traitement (3.16) ou adaptation/modification d’une méthode de traitement, qui en est à un
stade précoce de développement par le laboratoire de la biobanque (3.2) et pour laquelle une évaluation
plus approfondie est nécessaire afin de déterminer si elle est utile pour une application donnée
3.4
prestataire externe
entité qui entreprend des aspects du prélèvement, du transport, de la préparation (3.14), de la
manipulation, de l’évaluation de l’homogénéité (3.7) et de la stabilité (3.21), des essais ou du stockage
des matériels biologiques dans le périmètre de son propre système de management, au nom de la
biobanque, sur une base contractuelle, ou dans le contexte de la validation (3.25) d’une méthode de
traitement (3.16)
Note 1 à l'article: Une entité peut être une organisation ou une société, publique ou privée.
3.5
faisabilité
évaluation pour savoir si la méthode de traitement (3.16) peut être appliquée pour produire le type
souhaité de matériel biologique en sortie, indépendamment des propriétés d’intérêt de ce matériel
biologique
3.6
adapté à l’usage prévu
adéquation à l’usage prévu
conforme aux exigences préétablies pour un usage prévu
Note 1 à l'article: Ces exigences peuvent être établies dans le cadre de la biobanque elle-même et/ou en
collaboration avec les utilisateurs. Il convient qu’elles tiennent compte des critères d’analyse et autres critères
pertinents.
Note 2 à l'article: Ces exigences correspondent à la faisabilité (3.5) de l’usage prévu en aval et à la satisfaction de
critères de performance (3.12) prédéfinis pour l’usage prévu.
[SOURCE: ISO 20387:2018, 3.24, modifiée — Note 2 à l’article ajoutée]
3.7
homogénéité
uniformité d’une valeur de propriété quantitative ou qualitative spécifiée, dans une portion définie [ou
entre différentes aliquotes (3.1)] d’un matériel biologique
3.8
qualification de l’installation
QI
processus visant à établir par des preuves objectives que tous les principaux aspects de l’installation de
l’équipement et du système auxiliaire du procédé sont conformes à la spécification approuvée
[SOURCE: ISO 11139:2018, 3.220.2]
3.9
mesurande
grandeur que l’on veut mesurer
[SOURCE: Guide ISO/IEC 99:2007, 2.3, modifiée — Notes à l’article et exemples supprimés]
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3.10
mesurage
processus consistant à obtenir expérimentalement une ou plusieurs valeurs que l’on peut
raisonnablement attribuer à une grandeur
Note 1 à l'article: Les mesurages ne s’appliquent pas aux propriétés qualitatives.
Note 2 à l'article: Un mesurage implique la comparaison de grandeurs ou le comptage d’entités.
Note 3 à l'article: Un mesurage suppose une description de la grandeur compatible avec l’usage prévu d’un
résultat de mesure, une procédure de mesure et un système de mesure étalonné fonctionnant selon la procédure
de mesure spécifiée, incluant les conditions de mesure.
[SOURCE: Guide ISO/IEC 99:2007, 2.1]
3.11
qualification opérationnelle
QO
processus d’obtention de preuves documentées selon lesquelles l’équipement installé fonctionne dans
les limites prédéterminées, dans la mesure où il est utilisé conformément à son mode opératoire
[SOURCE: ISO 11139:2018, 3.220.3]
3.12
performance
ensemble des propriétés d’intérêt d’un matériel biologique, produit par une méthode de traitement
(3.16), par exemple rendement, pureté, intégrité, viabilité, fonctionnalité
3.13
qualification de performance
QP
processus visant à établir par des preuves objectives que le procédé, dans les conditions anticipées,
produit de façon constante un produit conforme à toutes les exigences prédéterminées
[SOURCE: ISO 11139:2018, 3.220.4]
3.14
préparation
activités se déroulant dans un laboratoire après l’acquisition, visant à préparer des matériels biologiques
en vue d’une utilisation ultérieure au cours du cycle de vie, du stockage ou de la distribution
Note 1 à l'article: Ces activités peuvent inclure, par exemple, la détermination du volume ou du poids, la
centrifugation, l’homogénéisation, la purification, la séparation, la fixation, la stabilisation, la filtration, le tri, la
mise en culture, le séchage sous vide, la lyophilisation, le fractionnement, l’aliquotage, le prélèvement de tissus,
la découpe / le broyage / le modelage, le lavage / l’immersion ou l’humidification avec des solutions antibiotiques
ou antimicrobiennes, la réduction du volume / la concentration, la déminéralisation, la glycérolisation, la
stérilisation, la congélation contrôlée ou non contrôlée, la vitrification, la cryoconservation.
[SOURCE: ISO 20387:2018, 3.37, modifiée — Note 1 à l’article modifiée afin d’ajouter des informations
plus détaillées]
3.15
traitement
conduite de toute activité sur des matériels biologiques et les données associées à toutes les étapes du
cycle de vie
[SOURCE: ISO 20387:2018, 3.36]
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3.16
méthode de traitement
procédure appliquée aux matériels biologiques et/ou aux données associées lors du traitement (3.15),
susceptible d’avoir une incidence sur les propriétés intrinsèques des matériels biologiques et/ou des
données associées produits en sortie
Note 1 à l'article: Une méthode de traitement peut comprendre, sans pour autant s’y limiter, des activités
appartenant aux domaines suivants: prélèvement, préparation (3.14), conservation, stockage.
Note 2 à l'article: La totalité ou une partie d’une méthode de traitement peut être une méthode normalisée.
Note 3 à l'article: Le terme «normalisée» dans cet exemple fait référence à la définition plus large de «norme» —
c’est-à-dire un ensemble d’exigences convenues.
Note 4 à l'article: Une méthode de traitement simple est une méthode de traitement qui nécessite une manipulation
simple en laboratoire (par exemple centrifugation de tubes de prélèvement ou broyage mécanique de tissus) sans
l’ajout de substances chimiques par le technicien de laboratoire de la biobanque (3.2) et sans lyse cellulaire ou
sélection de cellules au cours d’un processus multi-étapes (par exemple préparation du plasma, sérum, couche
leuco-plaquettaire).
Note 5 à l'article: Une méthode de traitement complexe est une méthode de traitement qui nécessite l’utilisation
de plusieurs étapes et/ou l’ajout de substances chimiques par le technicien de laboratoire de la biobanque (par
exemple préparation d’ADN, d’ARN, de protéines, de noyaux et autres organites, de lignées cellulaires).
Note 6 à l'article: Les essais qualitatifs ou quantitatifs pour l’examen des caractéristiques de propriétés/qualité/
quantité des matériels biologiques produits sont hors du domaine d’application de la «méthode de traitement»
proprement dite. Toutefois, un essai qualitatif ou quantitatif peut faire partie d’une «méthode de traitement»
s’il est nécessaire en tant qu’étape de «contrôle en cours de traitement» pendant la réalisation de la méthode de
traitement.
[SOURCE: ISO 20387:2018, 3.38, modifiée — Notes à l’article ajoutées]
3.17
essai d’aptitude
évaluation de la performance (3.12) d’un participant par rapport à des critères préétablis au moyen de
comparaisons interlaboratoires
[SOURCE: ISO/IEC 17043:2010, 3.7, modifiée — Notes à l’article supprimées]
3.18
propriété d’intérêt
propriété ou caractéristique physique, chimique, biologique ou microbiologique qui décrit la qualité ou
qui en est un indicateur
3.19
reproductibilité
coefficient de variation (CV en %) d’une valeur de propriété mesurée dans des
matériels biologiques qui constituent l’élément de sortie du traitement (3.15) d’aliquotes (3.1) provenant
du même matériel biologique d’entrée (par exemple volume, poids, concentration)
Note 1 à l'article: La reproductibilité d’une méthode de traitement (3.16) comprend des composantes provenant
de la méthode de traitement proprement dite et de l’incertitude analytique de la méthode d’essai utilisée pour
évaluer la reproductibilité.
Note 2 à l'article: En général, pour un ensemble donné d’informations, il est entendu que la reproductibilité d’une
méthode de traitement est associée à un mesurande (3.9) donné. Une modification de ce mesurande et de la
méthode d’essai entraîne une modification de la reproductibilité associée.
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3.20
robustesse
capacité d’une méthode de traitement (3.16) à produire des matériels
biologiques dont les propriétés restent dans des limites définies malgré les écarts par rapport aux
conditions expérimentales décrites dans la procédure opérationnelle normalisée (SOP) (3.22) de la
méthode de traitement
3.21
stabilité
capacité d’un matériel biologique, lorsqu’il est entreposé dans des conditions spécifiées, à conserver
une valeur de propriété donnée dans des limites spécifiées, pour une période de temps spécifiée
[SOURCE: Guide ISO 30:2015, 2.1.15, modifiée — Le terme « matériau de référence » a été remplacé
par « matériel biologique » et la Note 1 à l’article a été supprimée]
3.22
procédure opérationnelle normalisée
SOP
procédure écrite prescrite pour un usage répétitif en tant que pratique, conformément à des
spécifications convenues, visant à obtenir un résultat souhaité
3.23
méthode de traitement normalisée
méthode officiellement acceptée et reconnue, décrite en détail sans ambiguïté et validée pour un
objectif défini
Note 1 à l'article: Les méthodes de traitement normalisées comprennent, par exemple, les méthodes publiées
par un organisme de normalisation ou approuvées par les autorités réglementaires ou encore publiées dans la
littérature scientifique évaluée par des pairs, dédiées au moins partiellement à la validation (3.25) de la méthode.
Note 2 à l'article: Le terme «normalisée» dans cet exemple fait référence à la définition plus large de «norme» —
c’est-à-dire un ensemble d’exigences convenues.
3.24
contrainte
exposition intentionnelle d’un matériel biologique à des conditions qui diffèrent des conditions ou
procédures de routine prédéfinies et qui peuvent avoir un impact sur les propriétés du matériel
biologique
3.25
validation
confirmation par des preuves objectives que les exigences pour une utilisation spécifique ou une
application prévues ont été satisfaites
Note 1 à l'article: Les preuves objectives requises pour la validation peuvent être le résultat d’un essai ou d’une
autre forme de détermination, telle que la réalisation de calculs ou la revue de documents.
Note 2 à l'article: Le terme « validé » est utilisé pour désigner l’état correspondant.
Note 3 à l'article: Pour la validation, les conditions d’utilisation peuvent être réelles ou simulées.
Note 4 à l'article: La validation est la confirmation que les spécifications annoncées par le laboratoire de la
biobanque (3.2) sont respectées.
[SOURCE: ISO 9000:2015, 3.8.13, modifiée — Note 4 à l’article ajoutée]
3.26
vérification
confirmation par des preuves objectives que les exigences spécifiées ont été satisfaites
Note 1 à l'article: La vérification est la confirmation que les spécifications annoncées par un fournisseur, par une
publication ou par une autre source externe sont respectées.
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ISO 21899:2020(F)

Note 2 à l'article: Les preuves objectives requises pour la vérification peuvent être le résultat d’un contrôle ou
d’autres formes de détermination, telles que la réalisation de calculs ou la revue de documents.
Note 3 à l'article: Les activités réalisées pour la vérification sont parfois appelées processus de qualification.
Note 4 à l'article: Le terme « vérifié » est utilisé pour désigner l’état correspondant.
[SOURCE: ISO 9000:2015, 3.8.12, modifiée — Note 1 à l’article ajoutée]
4 Termes abrégés
Terme abrégé Explication
CPT tube de préparation de cellules
CV coefficient de variation
Hly hémolysine
n nombre d’échantillons
M carré moyen
OD densité optique
PBMC cellules mononuclées de sang périphérique
PCA analyse en composantes principales
RT température ambiante
u variance
S écart-type
SOP procédure opérationnelle normalisée
5 Généralités et exigences relatives aux ressources
La biobanque doit établir, mettre en place et tenir à jour un système de management de la qualité
documenté. (Voir par exemple l’ISO 9001 ou l’ISO 20387:2018, Article 8.)
Les exigences relatives au personnel, à l’infrastructure et aux conditions environnementales, ainsi qu’au
ma
...