Biotechnology -- Biobanking -- Requirements for the biobanking of plant biological material for research and development

This document specifies requirements for the collection, preparation, preservation, transportation, storage, distribution and disposal of plant biological materials and associated data. This document is applicable only to biological material that can be used for further processing of biomolecules, e.g. nucleic acids, proteins and metabolites. This document is applicable to all organizations performing plant biobanking for research and development.

Biotechnologie -- Biobanking -- Exigences relatives au biobanking de matériels biologiques végétaux pour la recherche et le développement

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Status
Published
Publication Date
05-Oct-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
16-Aug-2021
Completion Date
16-Aug-2021
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TECHNICAL ISO/TS
SPECIFICATION 23105
First edition
2021-10
Biotechnology — Biobanking —
Requirements for the biobanking of
plant biological material for research
and development
Biotechnologie — Biobanking — Exigences relatives au biobanking
de matériels biologiques végétaux pour la recherche et le
développement
Reference number
ISO/TS 23105:2021(E)
© ISO 2021
---------------------- Page: 1 ----------------------
ISO/TS 23105:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 23105:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 General requirements .................................................................................................................................................................................... 3

5 Biological material collection ................................................................................................................................................................3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Collection procedure ......................................................................................................................................................................... 3

5.3 Preparation of collection containers, tools, supplies, reagents and consumables ..................... 4

5.4 Biological material traceability ............................................................................................................................................... 6

5.5 Collection ..................................................................................................................................................................................................... 6

6 Transport of biological material and associated data ................................................................................................ 7

7 Preparation and preservation of biological material .................................................................................................. 8

7.1 General ........................................................................................................................................................................................................... 8

7.2 Cutting, cleaning and bagging .................................................................................................................................................. 8

7.3 Desiccation ................................................................................................................................................................................................. 9

7.4 Snap freezing and cryopreservation ................................................................................................................................... 9

7.5 Fast or rapid drying ........................................................................................................................................................................... 9

7.5.1 General ........................................................................................................................................................................................ 9

7.5.2 Drying with dried spots card ............................................................................................................................... 10

7.5.3 Air-dried or oven-dried ............................................................................................................................................. 10

7.6 Grinding ..................................................................................................................................................................................................... 10

7.7 Biological material preservation in protective solution ................................................................................ 10

8 Storage of biological material .............................................................................................................................................................11

8.1 General ........................................................................................................................................................................................................ 11

8.2 Storage temperature ...................................................................................................................................................................... 11

8.3 Biological material multiplication ...................................................................................................................................... 11

8.4 Monitoring of biological material .......................................................................................................................................12

9 Distribution and disposal of biological material ...........................................................................................................13

10 Information collection ................................................................................................................................................................................13

Annex A (informative) Typical biological material storage temperatures and storage

durations ...................................................................................................................................................................................................................14

Annex B (informative) Exemplary information table for plant biological material ......................................15

Bibliography .............................................................................................................................................................................................................................19

iii
© ISO 2021 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/TS 23105:2021(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.
© ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 23105:2021(E)
Introduction

Biobanking of plant biological materials is fundamental for botanical and agro-ecosystem research,

sustainable crop development and production, ensuring genetic diversity and conservation. Biobank

biological material collection and accession management are strategic to optimizing plant genetic

resources. A plant biobank obtains its accessions in different ways, e.g. from donors (principally

researchers or breeders), by collecting the biological material from the field and by exchange with

other plant biobanks. Biological collections encompass numerous biological material types, including

frozen plant tissues, fluid preserved plant tissues or associated extracts or some or all of them. These

collections often require specialized experts to curate and assemble the collection. Appropriate

biological material processing and storage conditions are also needed to maintain high-quality

collections and maximize the potential of positive outcomes. This document provides guidance on how

to collect, process, store, track and distribute plant biological materials.

Standards are needed for the collection, preparation, preservation, transportation and storage of plant

biological materials for academic institutions, non-profit organizations and commercial agronomic

businesses. This document provides the specific requirements, guidelines and effective practices for

biobanking plant biological materials based on the current and available technological and scientific

knowledge.
© ISO 2021 – All rights reserved
---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 23105:2021(E)
Biotechnology — Biobanking — Requirements for the
biobanking of plant biological material for research and
development
1 Scope

This document specifies requirements for the collection, preparation, preservation, transportation,

storage, distribution and disposal of plant biological materials and associated data.

This document is applicable only to biological material that can be used for further processing of

biomolecules, e.g. nucleic acids, proteins and metabolites.

This document is applicable to all organizations performing plant biobanking for research and

development.
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 20387:2018, Biotechnology — Biobanking — General requirements for biobanking
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
associated data

any information affiliated with biological material (3.4) including but not limited to research,

phenotypic, clinical, epidemiologic, phytosanitary certificate and procedural data

Note 1 to entry: Associated data can include metadata.

[SOURCE: ISO 20387:2018, 3.3, modified — “phytosanitary certificate” and Note 1 to entry have been

added.]
3.2
biobank
legal entity or part of a legal entity that performs biobanking (3.3)
[SOURCE: ISO 20387:2018, 3.5]
© ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
ISO/TS 23105:2021(E)
3.3
biobanking

process of acquisitioning and storing, together with some or all of the activities related to collection,

preparation, preservation (3.9), testing, analysing and distributing defined biological material (3.4) as

well as related information and data
[SOURCE: ISO 20387:2018, 3.6]
3.4
biological material

plant as a whole, or any substance derived or part obtained from the plant

entity
3.5
dried spots card

card containing chemicals that lyse cells, denature proteins and protect nucleic acids from nucleases

as well as from oxidative and ultraviolet damage; can be used to process plant biological material (3.4)

homogenates
3.6
life cycle

consecutive and interlinked processes applied to biological material (3.4) and associated data (3.1) from

collection, if applicable, acquisition or reception to distribution, disposal or destruction

Note 1 to entry: This term refers to the biobanking (3.3) life cycle only.
[SOURCE: ISO 20387:2018, 3.29]
3.7
plant genetic resource

genetic material of plant origin, containing functional units of heredity (e.g. DNA or RNA), or elements

thereof (e.g. mRNA, mtDNA)
3.8
plant biobank
plant genetic resource bank
plant gene bank
plant BRC

legal entity or part of a legal entity that performs the process of acquisitioning and storing, as well as

some or all of the following activities: collection, preparation, preservation (3.9), testing, analysing and

distributing defined plant genetic resource (3.7) as well as related information and data

Note 1 to entry: “Plant BRC” stands for “Plant Biological Resource Center”.
3.9
preservation

act of preventing or retarding biological or physical deterioration of biological material (3.4)

[SOURCE: ISO 20387:2018, 3.34, modified — “act of preventing or retarding” has replaced “act to

prevent or retard”.]
3.10
processing

performing any activity on biological material (3.4) and associated data (3.1) during all stages of the life

cycle (3.6)
[SOURCE: ISO 20387:2018, 3.36]
3.11
rejuvenation
growth of a vegetative propagule
© ISO 2021 – All rights reserved
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ISO/TS 23105:2021(E)
3.12
vegetative structures
whole or portion of a plant not including the seeds

Note 1 to entry: In the scope of this document, vegetative structures can include propagules.

4 General requirements
The biobank shall follow ISO 20387:2018, Clauses 4 to 7.

The biobank shall establish, implement and maintain a quality management system in accordance with

ISO 20387:2018, Clause 8.

The biobank shall identify each biological material and associated data relevant to the application of

this document.

The biobank shall have procedures addressing biobanking for each type of biological material (e.g.

whole plant, seeds, tuber, bulbs, scion wood, leaf, root, DNA, RNA) and associated data. This includes

processes such as collection, acquisition, reception, characterization/evaluation, storage, preparation,

preservation, rejuvenation and distribution.

The biobank shall ensure the legitimate acquisition of biological material and its associated data,

and the retention of any relevant documentation. If legitimate acquisition cannot be demonstrated,

the biological material shall be discarded, according to documented procedures, and this shall be

documented.

NOTE 1 Such documentation can relate to relevant documents such as international treaties and agreements,

and a phytosanitary certificate or passport.

NOTE 2 Legitimate acquisition can refer to relevant regulation, permits or authorization.

[3]

The biobank shall ensure that biorisk management procedures (e.g. ISO 35001, WHO guidance ) for

potential plant pests and pathogens are established, documented, implemented and maintained, as

appropriate.
The biobank shall take measures to prevent cross contamination.

The biobank or the legal entity of which it is a part shall ensure that human health and safety

requirements are established, documented, implemented and maintained. The level of safety training

required shall be determined using a comprehensive risk assessment of the biological and chemical

materials, processes and equipment that is handled (see ISO 20387:2018, 6.2.1.5).

5 Biological material collection
5.1 General

Where possible, the intended purpose or final use of the biological material and associated data shall

be determined, either by the biobank alone, in response to end-user criteria or by the biobank in

conjunction with the end user. If determined, the intended or potential purpose shall be documented.

5.2 Collection procedure

5.2.1 The biobank shall develop and implement documented biological material collection procedures

appropriate for each type of biological material according to its biological nature and intended purpose,

where known. The biobank shall define biological material acceptance criteria.
© ISO 2021 – All rights reserved
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ISO/TS 23105:2021(E)

5.2.2 The collection procedure shall address requirements for authentication, minimum quantity,

viability, stability and maintenance to satisfy the fitness for purpose, where known. The collection

procedure shall also address the following aspects, including but not limited to:

a) biological material type;
b) fitness for purpose, where known;
c) total number and amount comprising each biological material per collection;
d) containers that are fit for purpose (e.g. closure integrity, composition);
e) equipment;
f) collection method;

g) quality criteria for each biological material (e.g. the quantity and quality of targeted analytes such

as DNA, RNA or protein);
h) collection location(s) (e.g. by GPS), schedule, personnel and assignment;
i) stage of maturity of the biological material.

5.2.3 When developing collection procedures, the following information shall be evaluated for

inclusion:

a) taxonomic information, vernacular names, morphological characters and habitat;

b) geographical distribution and known populations;
c) population size and identified number of propagules to be collected;
d) recognized identification system of propagules;
e) statistical demographics for collection;

f) physiological traits that are relevant for plant biological material sampling;

g) information on putative plant disease or associated pests;

h) historical collection information, the appropriate season and timing for collection, and

environmental information such as climate and accessibility;
i) permits required for collection, transportation, export and import.
The evaluation result shall be documented.

5.2.4 The biobank shall identify risks associated with the collection procedure for each biological

material and take appropriate feasible measure(s) to mitigate the risks according to the likelihood of

occurrence and the possible impacts. It is up to the biobank or the legal entity of which it is a part, or

both, to determine what measures are appropriate and feasible.

5.2.5 The biobank shall define and document information related to the biological material (see

Annex B and ISO 20387:2018, 7.2.1.1, 7.2.1.2, A.2 and B.2).

5.3 Preparation of collection containers, tools, supplies, reagents and consumables

The tools for collection, such as instruments, consumables and personal protective equipment, should

be prepared and checked prior to collection. Preparing a checklist before collection can help to ensure

an uninterrupted and efficient procedure.
© ISO 2021 – All rights reserved
---------------------- Page: 9 ----------------------
ISO/TS 23105:2021(E)

The collection procedure shall include the preparation of collection containers, tools and other supplies

(e.g. ink, labels or tags) required for each biological material collection. When appropriate, this shall

include, but is not limited to, the following:
a) collection containers and seals;

b) contamination prevention through appropriate care, cleaning or sterilization or both of collection

tools such as cutting devices, instruments, containers and reagents;
c) collection instruments;
d) collection consumables;
e) personal protective equipment;
f) information recording tools;
g) reminder systems, e.g. checklists.

NOTE When needed, containers, instruments and consumables can be sterilized prior to collection.

Specifications for collection container, tool, supply, reagent and consumable requirements and

recommendations by type of biological material are listed in Table 1.

Table 1 — Collection container, tool, supply, reagent and consumable specifications by type of

biological material
Biological material Specifications
type

Vegetative structures Containers shall be clean and able to maintain the desired moisture content or

(whole or part) temperature, e.g. aluminium foil can be used.

If necessary, biological material, especially those containing plastids, should be

protected from light (e.g. aluminium foil wrapping, dark containers). Air should be

excluded as much as possible.

Debris, where present, should be removed, e.g. through use of a soft brush or clean

water or both.

Seeds Containers to maintain the desired moisture content range or which keep the biolog-

ical material dry/cool shall be prepared before collection, according to the biological

material properties and intended purpose.
Seeds should be collected into containers minimizing light and air.
As much as possible, seeds should be collected with minimized debris.

Biological material for A container designed to minimize sample degradation, e.g. DNase free or RNase free

biomolecular research or pyrogen free to preserve genetic integrity, should be used.

Clean cryotubes with secure top lids or appropriate sealable plastic bags produced by

clean manufacturing technology can be selected for transportation and storage at or

below −18 °C.
Dehydration shall be avoided in the container.

Debris, where present, should be removed, e.g. through use of a soft brush or clean

water or both. Use a collection receptacle appropriate for the biological material

collection criteria, e.g. containers capable of maintaining desired moisture content or

temperature range, aluminium foil to minimize exposure to light/air.
Care should be taken during collection and processing to prevent the activity of
RNases, both endogenous and those introduced by environmental contamination.
© ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
ISO/TS 23105:2021(E)
5.4 Biological material traceability
The biobank shall follow ISO 20387:2018, 7.5, 7.7.2, 7.7.4 and 7.10.

The label or tag shall not inhibit fitness of purpose of the biological material and associated data for the

intended purpose, where known.

A system (e.g. double tag, mapping of storage) shall be applied to prevent the loss of biological material

identity.

The label or tag can also be tied to the biological material or pasted on the container. Containers shall

be appropriately labelled or tagged to prevent the tag from fading or falling off so that identification is

maintained throughout the life cycle of the biological material.
5.5 Collection

Information defined as relevant to the collection procedure shall be documented in a traceable manner.

Multiple individuals from the same population should be collected to meet the minimum number and

amount requirements detailed in the collection procedure.

Biological material should be collected without visible parasitic or microbial contaminants unless these

are the target material. If necessary, a treatment prior to conservation or use or both shall be applied.

Individual biological material should be collected in separate containers.
Collection specifications by type of biological material are listed in Table 2.
Table 2 — Collection specifications by type of biological material
Biological material type Specifications

Vegetative Whole plant If collecting the entire plant, live collection should be performed. The plant

structures material should be kept under conditions similar to the original habitat.

(whole or part) The collected plant should grow normally without injury. Where appropriate,

remove the majority of leaves to reduce transpiration, retain at least one
node, wrap with moist material (e.g. wet newspaper) and protect against
contamination; non-seed propagules are also suitable.

Tuber, bulbs The vegetative propagules (i.e. tuber, bulbs and roots) should remain healthy

or root and without injury. The remaining propagators should not be so small as to

hinder the natural regeneration of the plant population.
The tuber, bulb or root should be carefully dug out from the ground during
collection, paying attention to its branching. When transferring the tuber,
bulb or root from the place of harvest into a prepared container, the
harvested biological material should be protected against contamination.
Scionwood The majority of leaves should be removed to reduce transpiration. The
scionwood should be kept in ambient conditions.
Pollen For plants with heavy dry pollen, the flowers can be beaten over a 500 μm
sieve. When no free pollen is available, anthers can be collected.
NOTE Anthers release the pollen from the inside after they are dried.
For in wind fertilized species, male flowers should be enclosed within paper
bags to collect the pollen in a sufficient quantity.
Leaves Collected leaves can be put into a container to keep the necessary water
regime.
© ISO 2021 – All rights reserved
---------------------- Page: 11 ----------------------
ISO/TS 23105:2021(E)
Table 2 (continued)
Biological material type Specifications

Biological Care should be taken during collection and processing to prevent the activity of RNases,

material for both endogenous and those introduced by environmental contamination.

biomolecular

For RNA or protein research, collection should minimize the conditions that degrade or

research
alter the RNA or proteome.
Leaves Young (but not too young), fresh, undamaged leaves should be used.
Diseased, damaged, dead plant material and leaves stressed by excessive
heat, cold or moisture should generally be avoided.
For larger plants, the most recent mature leaf (MRML), which is the first fully
expanded leaf below the growing point, should be used.
If an envelope with silica gel is used, the leaf can be cut into pieces before
putting it into the envelope. The envelope should not be overfilled. For better
drying, adding large clumps of leaves to the envelope should be avoided. The
air should be pushed out of the envelope; afterwards, the envelope should be
sealed tight.

Tuber, bulbs Removal of any adhering soil can be done by brushing and, if necessary,

or root gently rinsing with cold running water. Tops can be trimmed off. Details of

any trimming should be documented. The trimmed tops should be bagged
separately, if needed.
Seeds The biobank shall define the moisture level for seed preservation. The
defined storage humidity depends on the kind of seeds.
It is recommended to take at minimum between 30 samples and 60 samples
by accession according to the biological status and multiplication method.
For endangered populations, no more than 20 % of the available seeds may
be collected.
The frequency of empty or damaged seeds should be estimated. The maturity
of the seeds should be evaluated.
Seeds should be high viability, free from diseases and pests, and able to
maintain adequate levels of germination.
The biological material should comprise at least 500 viable seeds for
outbreeders and heterogeneous accessions with high diversity and a
minimum of 300 seeds for genetically uniform accessions.

Other biological Bryophytes The entirety of living parts should be collected, preferentially in the

materials sporophytes phase, including fruiting bodies, when available.
Fern If frond is needed, young fully expanded mature fern should be used.
Spores can be collected from the fertile frond bearing sori or sporangia.
Ripe and mature sporangia should be collected. Any soil or dust on the frond
surfaces should be gently brushed or washed off. The fertile frond s
...

TECHNICAL ISO/TS
SPECIFICATION 23105
First edition
Biotechnology — Biobanking —
Requirements for the biobanking of
plant biological material for research
and development
PROOF/ÉPREUVE
Reference number
ISO/TS 23105:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO/TS 23105:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 23105:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 General requirements ..................................................................................................................................................................................... 3

5 Biological material collection ................................................................................................................................................................. 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Collection procedure .......................................................................................................................................................................... 3

5.3 Preparation of collection containers, tools, supplies, reagents and consumables ....................... 4

5.4 Biological material traceability ................................................................................................................................................. 6

5.5 Collection ..................................................................................................................................................................................................... 6

6 Transport of biological material and associated data ................................................................................................... 7

7 Preparation and preservation of biological material .................................................................................................... 8

7.1 General ........................................................................................................................................................................................................... 8

7.2 Cutting, cleaning and bagging .................................................................................................................................................... 8

7.3 Desiccation ................................................................................................................................................................................................. 9

7.4 Snap freezing and cryopreservation .................................................................................................................................... 9

7.5 Fast or rapid drying ............................................................................................................................................................................ 9

7.5.1 General...................................................................................................................................................................................... 9

7.5.2 Drying with dried spots card..............................................................................................................................10

7.5.3 Air-dried or oven-dried ...........................................................................................................................................10

7.6 Grinding .....................................................................................................................................................................................................10

7.7 Biological material preservation in protective solution ...................................................................................10

8 Storage of biological material ..............................................................................................................................................................11

8.1 General ........................................................................................................................................................................................................11

8.2 Storage temperature .......................................................................................................................................................................11

8.3 Biological material multiplication .......................................................................................................................................11

8.4 Monitoring of biological material ........................................................................................................................................12

9 Distribution and disposal of biological material .............................................................................................................13

10 Information collection .................................................................................................................................................................................13

Annex A (informative) Typical biological material storage temperatures and storage durations ...14

Annex B (informative) Exemplary information table for plant biological material ........................................15

Bibliography .............................................................................................................................................................................................................................19

© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO/TS 23105:2021(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 PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 23105:2021(E)
Introduction

Biobanking of plant biological materials is fundamental for botanical and agro-ecosystem research,

sustainable crop development and production, ensuring genetic diversity and conservation. Biobank

biological material collection and accession management are strategic to optimizing plant genetic

resources. A plant biobank obtains its accessions in different ways, e.g. from donors (principally

researchers or breeders), by collecting the biological material from the field and by exchange with

other plant biobanks. Biological collections encompass numerous biological material types, including

frozen plant tissues, fluid preserved plant tissues or associated extracts or some or all of them. These

collections often require specialized experts to curate and assemble the collection. Appropriate

biological material processing and storage conditions are also needed to maintain high-quality

collections and maximize the potential of positive outcomes. This document provides guidance on how

to collect, process, store, track and distribute plant biological materials.

Standards are needed for the collection, preparation, preservation, transportation and storage of plant

biological materials for academic institutions, non-profit organizations and commercial agronomic

businesses. This document provides the specific requirements, guidelines and effective practices for

biobanking plant biological materials based on the current and available technological and scientific

knowledge.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 23105:2021(E)
Biotechnology — Biobanking — Requirements for the
biobanking of plant biological material for research and
development
1 Scope

This document specifies requirements for the collection, preparation, preservation, transportation,

storage, distribution and disposal of plant biological materials and associated data.

This document is applicable only to biological material that can be used for further processing of

biomolecules, e.g. nucleic acids, proteins and metabolites.

This document is applicable to all organizations performing plant biobanking for research and

development.
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 20387:2018, Biotechnology — Biobanking — General requirements for biobanking
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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
associated data

any information affiliated with biological material (3.4) including but not limited to research,

phenotypic, clinical, epidemiologic, phytosanitary certificate and procedural data

Note 1 to entry: Associated data can include metadata.

[SOURCE: ISO 20387:2018, 3.3, modified — “phytosanitary certificate” and Note 1 to entry have been

added.]
3.2
biobank
legal entity or part of a legal entity that performs biobanking (3.3)
[SOURCE: ISO 20387:2018, 3.5]
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3.3
biobanking

process of acquisitioning and storing, together with some or all of the activities related to collection,

preparation, preservation (3.9), testing, analysing and distributing defined biological material (3.4) as

well as related information and data
[SOURCE: ISO 20387:2018, 3.6]
3.4
biological material

plant as a whole, or any substance derived or part obtained from the plant

entity
3.5
dried spots card

card containing chemicals that lyse cells, denature proteins and protect nucleic acids from nucleases

as well as from oxidative and ultraviolet damage; can be used to process plant biological material (3.4)

homogenates
3.6
life cycle

consecutive and interlinked processes applied to biological material (3.4) and associated data (3.1) from

collection, if applicable, acquisition or reception to distribution, disposal or destruction

Note 1 to entry: This term refers to the biobanking (3.3) life cycle only.
[SOURCE: ISO 20387:2018, 3.29]
3.7
plant genetic resource

genetic material of plant origin, containing functional units of heredity (e.g. DNA or RNA), or elements

thereof (e.g. mRNA, mtDNA)
3.8
plant biobank
plant genetic resource bank
plant gene bank
plant BRC

legal entity or part of a legal entity that performs the process of acquisitioning and storing, as well as

some or all of the following activities: collection, preparation, preservation (3.9), testing, analysing and

distributing defined plant genetic resource (3.7) as well as related information and data

Note 1 to entry: “Plant BRC” stands for “Plant Biological Resource Center”.
3.9
preservation

act of preventing or retarding biological or physical deterioration of biological material (3.4)

[SOURCE: ISO 20387:2018, 3.34, modified — “act of preventing or retarding” has replaced “act to

prevent or retard”.]
3.10
processing

performing any activity on biological material (3.4) and associated data (3.1) during all stages of the life

cycle (3.6)
[SOURCE: ISO 20387:2018, 3.36]
3.11
rejuvenation
growth of a vegetative propagule
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3.12
vegetative structures
whole or portion of a plant not including the seeds

Note 1 to entry: In the scope of this document, vegetative structures can include propagules.

4 General requirements
The biobank shall follow ISO 20387:2018, Clauses 4 to 7.

The biobank shall establish, implement and maintain a quality management system in accordance with

ISO 20387:2018, 8.2 to 8.9.

The biobank shall identify each biological material and associated data relevant to the application of

this document.

The biobank shall have procedures addressing biobanking for each type of biological material (e.g.

whole plant, seeds, tuber, bulbs, scion wood, leaf, root, DNA, RNA) and associated data. This includes

processes such as collection, acquisition, reception, characterization/evaluation, storage, preparation,

preservation, rejuvenation and distribution.

The biobank shall ensure the legitimate acquisition of biological material and its associated data,

and the retention of any relevant documentation. If legitimate acquisition cannot be demonstrated,

the biological material shall be discarded, according to documented procedures, and this shall be

documented.

NOTE 1 Such documentation can relate to relevant documents such as international treaties and agreements,

and a phytosanitary certificate or passport.

NOTE 2 Legitimate acquisition can refer to relevant regulation, permits or authorization.

[3]

The biobank shall ensure that biorisk management procedures (e.g. ISO 35001, WHO guidance ) for

potential plant pests and pathogens are established, documented, implemented and maintained, as

appropriate.
The biobank shall take measures to prevent cross contamination.

The biobank or the legal entity of which it is a part shall ensure that human health and safety

requirements are established, documented, implemented and maintained. The level of safety training

required shall be determined using a comprehensive risk assessment of the biological and chemical

materials, processes and equipment that is handled (see ISO 20387:2018, 6.2.1.5).

5 Biological material collection
5.1 General

Where possible, the intended purpose or final use of the biological material and associated data shall

be determined, either by the biobank alone, in response to end-user criteria or by the biobank in

conjunction with the end user. If determined, the intended or potential purpose shall be documented.

5.2 Collection procedure

5.2.1 The biobank shall develop and implement documented biological material collection procedures

appropriate for each type of biological material according to its biological nature and intended purpose,

where known. The biobank shall define biological material acceptance criteria.
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5.2.2 The collection procedure shall address requirements for authentication, minimum quantity,

viability, stability and maintenance to satisfy the fitness for purpose, where known. The collection

procedure shall also address the following aspects, including but not limited to:

a) biological material type;
b) fitness for purpose, where known;
c) total number and amount comprising each biological material per collection;
d) containers that are fit for purpose (e.g. closure integrity, composition);
e) equipment;
f) collection method;

g) quality criteria for each biological material (e.g. the quantity and quality of targeted analytes such

as DNA, RNA or protein);
h) collection location(s) (e.g. by GPS), schedule, personnel and assignment;
i) stage of maturity of the biological material.

5.2.3 When developing collection procedures, the following information shall be evaluated for

inclusion:

a) taxonomic information, vernacular names, morphological characters and habitat;

b) geographical distribution and known populations;
c) population size and identified number of propagules to be collected;
d) recognized identification system of propagules;
e) statistical demographics for collection;

f) physiological traits that are relevant for plant biological material sampling;

g) information on putative plant disease or associated pests;

h) historical collection information, the appropriate season and timing for collection, and

environmental information such as climate and accessibility;
i) permits required for collection, transportation, export and import.
The evaluation result shall be documented.

5.2.4 The biobank shall identify risks associated with the collection procedure for each biological

material and take appropriate feasible measure(s) to mitigate the risks according to the likelihood of

occurrence and the possible impacts. It is up to the biobank or the legal entity of which it is a part, or

both, to determine what measures are appropriate and feasible.

5.2.5 The biobank shall define and document information related to the biological material (see

Annex B and ISO 20387:2018, 7.2.1.1, 7.2.1.2, A.2 and B.2).

5.3 Preparation of collection containers, tools, supplies, reagents and consumables

The tools for collection, such as instruments, consumables and personal protective equipment, should

be prepared and checked prior to collection. Preparing a checklist before collection can help to ensure

an uninterrupted and efficient procedure.
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The collection procedure shall include the preparation of collection containers, tools and other supplies

(e.g. ink, labels or tags) required for each biological material collection. When appropriate, this shall

include, but is not limited to, the following:
a) collection containers and seals;

b) contamination prevention through appropriate care, cleaning or sterilization or both of collection

tools such as cutting devices, instruments, containers and reagents;
c) collection instruments;
d) collection consumables;
e) personal protective equipment;
f) information recording tools;
g) reminder systems, e.g. checklists.

NOTE When needed, containers, instruments and consumables can be sterilized prior to collection.

Specifications for collection tool requirements and recommendations by type of biological material are

listed in Table 1.
Table 1 — Collection tool specifications by type of biological material
Biological material Specifications
type

Vegetative structures Containers shall be clean and able to maintain the desired moisture content or

(whole or part) temperature, e.g. aluminium foil can be used.

If necessary, biological material, especially those containing plastids, should be

protected from light (e.g. aluminium foil wrapping, dark containers). Air should be

excluded as much as possible.

Debris, where present, should be removed, e.g. through use of a soft brush or clean

water or both.

Seeds Containers to maintain the desired moisture content range or which keep the biolog-

ical material dry/cool shall be prepared before collection, according to the biological

material properties and intended purpose.
Seeds should be collected into containers minimizing light and air.
As much as possible, seeds should be collected with minimized debris.

Biological material for A container designed to minimize sample degradation, e.g. DNase free or RNase free

biomolecular research or pyrogen free to preserve genetic integrity, should be used.

Clean cryotubes with secure top lids or appropriate sealable plastic bags produced by

clean manufacturing technology can be selected for transportation and storage at or

below −18 °C.
Dehydration shall be avoided in the container.

Debris, where present, should be removed, e.g. through use of a soft brush or clean

water or both. Use a collection receptacle appropriate for the biological material

collection criteria, e.g. containers capable of maintaining desired moisture content or

temperature range, aluminium foil to minimize exposure to light/air.
Care should be taken during collection and processing to prevent the activity of
RNases, both endogenous and those introduced by environmental contamination.
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5.4 Biological material traceability
The biobank shall follow ISO 20387:2018, 7.5, 7.7.2, 7.7.4 and 7.10.

The label or tag shall not inhibit fitness of purpose of the biological material and associated data for the

intended purpose, where known.

A system (e.g. double tag, mapping of storage) shall be applied to prevent the loss of biological material

identity.

The label or tag can also be tied to the biological material or pasted on the container. Containers shall

be appropriately labelled or tagged to prevent the tag from fading or falling off so that identification is

maintained throughout the life cycle of the biological material.
5.5 Collection

Information defined as relevant to the collection procedure shall be documented in a traceable manner.

Multiple individuals from the same population should be collected to meet the minimum number and

amount requirements detailed in the collection procedure.

Biological material should be collected without visible parasitic or microbial contaminants unless these

are the target material. If necessary, a treatment prior to conservation or use or both shall be applied.

Individual biological material should be collected in separate containers.
Collection specifications by type of biological materials are listed in Table 2.
Table 2 — Collection specifications by type of biological material
Biological material type Specifications

Vegetative Whole plant If collecting the entire plant, live collection should be performed. The plant

structures materials should be kept under conditions similar to the original habitat.

(whole or part) The collected plant should grow normally without injury. Where appropriate,

remove the majority of leaves to reduce transpiration, retain at least one
node, wrap with moist material (e.g. wet newspaper) and protect against
contamination; non-seed propagules are also suitable.

Tuber, bulbs The vegetative propagules (i.e. tuber, bulbs and roots) should remain healthy

or root and without injury. The remaining propagators should not be so small as to

hinder the natural regeneration of the plant population.
The tuber, bulb or root should be carefully dug out from the ground during
collection, paying attention to its branching. When transferring the tuber,
bulb or root from the place of harvest into a prepared container, the
harvested biological material should be protected against contamination.
Scionwood The majority of leaves should be removed to reduce transpiration. The
scionwood should be kept in ambient conditions.
Pollen For plants with heavy dry pollen, the flowers can be beaten over a 500 μm
sieve. When no free pollen is available, anthers can be collected.
NOTE Anthers release the pollen from the inside after they are dried.
For in wind fertilized species, male flowers should be enclosed within paper
bags to collect the pollen in a sufficient quantity.
Leaves Collected leaves can be put into a container to keep the necessary water
regime.
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Table 2 (continued)
Biological material type Specifications

Biological Care should be taken during collection and processing to prevent the activity of RNases,

material for both endogenous and those introduced by environmental contamination.

biomolecular

For RNA or protein research, collection should minimize the conditions that degrade or

research
alter the RNA or proteome.
Leaves Young (but not too young), fresh, undamaged leaves should be used.
Diseased, damaged, dead plant material and leaves stressed by excessive
heat, cold or moisture should generally be avoided.
For larger plants, the most recent mature leaf (MRML), which is the first fully
expanded leaf below the growing point, should be used.
If an envelope with silica gel is used, the leaf can be cut into pieces before
putting it into the envelope. The envelope should not be overfilled. For better
drying, adding large clumps of leaves to the envelope should be avoided. The
air should be pushed out of the envelope; afterwards, the envelope should be
sealed tight.

Tuber, bulbs Removal of any adhering soil can be done by brushing and, if necessary,

or root gently rinsing with cold running water. Tops can be trimmed off. Details of

any trimming should be documented. The trimmed tops should be bagged
separately, if needed.
Seeds The biobank shall define the moisture level for seed preservation. The
defined storage humidity depends on the kind of seeds.
It is recommended to take at minimum between 30 samples and 60 samples
by accession according to the biological status and multiplication method.
For endangered populations, no more than 20 % of the available seed may be
collected.
The frequency of empty or damaged seeds should be estimated. The maturity
of the seeds should be evaluated.
Seeds should be high viability, free from diseases and pests, and able to
maintain adequate levels of germination.
The biological material should comprise at least 500 viable seeds for
outbreeders and heterogeneous accessions with high diversity and a
minimum of 300 seeds for genetically uniform accessions.

Other biological Bryophytes The entirety of living parts should be collected, preferentially in the

materials sporophytes phase, including fruiting bodies, when available.
Fern If frond is needed, young fully expanded mature fern should be used.
Spores can be collected from the fertile frond bearing sori or sporangia.
Ripe and mature sporangia should be collected. Any soil or dust on the frond
surfaces should be gently brushed or washed off. The fertile frond should be
placed with the sporangia side down into a clean leak-proof container (e.g.
paper). The fertile frond should be covered to prevent air movement. Spores
are usually shed in about one week. Cellophane or plastic bags should not be
used
...

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