Biotechnology -- Biobanking -- Requirements for animal biological material

This document specifies requirements for the collection, reception, preparation, preservation, transport, storage, distribution, destruction and disposal of biological materials obtained from animals, excluding humans. Such resources include solid tissues, fluid samples and associated cells, excretory products and associated data. This document is applicable to biological material or associated data, or both, that can be used for research and development and to biomolecules derived from the biological material, e.g. nucleic acids, proteins and metabolites. This document is applicable to all organizations performing biobanking for research and development. This document does not apply to biological material intended for food or feed production, laboratories undertaking analysis for food or feed production, or therapeutic use, or multiple of them. This document does not apply to the establishment of cell lines derived from animal biological material. NOTEÂ Â Â Â Â International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

Biotechnologie -- Banques biologiques -- Exigences relatives au matériel biologique animal

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Publication Date
02-Dec-2021
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ISO/TS 20388:2021 - Biotechnology -- Biobanking -- Requirements for animal biological material
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TECHNICAL ISO/TS
SPECIFICATION 20388
First edition
2021-12
Biotechnology — Biobanking —
Requirements for animal biological
material
Biotechnologie — Banques biologiques — Exigences relatives au
matériel biologique animal
Reference number
ISO/TS 20388:2021(E)
© ISO 2021
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ISO/TS 20388:2021(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

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Published in Switzerland
© ISO 2021 – All rights reserved
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ISO/TS 20388:2021(E)
Contents Page

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

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

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

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

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

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

4.1 General ........................................................................................................................................................................................................... 4

4.2 Ethical requirements ........................................................................................................................................................................ 4

4.3 Health and safety ...................................................................... ............................................................................................................ 4

4.3.1 General principles ............................................................................................................................................................. 4

4.3.2 Chemical safety ...................................................................... .............................................................................................. 5

4.3.3 Biosafety .................................................................................................................................................................................... 5

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

5.1 Prior to collection ................................................................................................................................................................................ 5

5.1.1 Pre-acquisition information ..................................................................................................................................... 5

5.1.2 Collection plan ...................................................................................................................................................................... 5

5.1.3 Preparation of collection containers, tools, supplies, reagents and

consumables ........................................................................................................................................................................... 6

5.2 Collection ..................................................................................................................................................................................................... 7

5.2.1 General ........................................................................................................................................................................................ 7

5.2.2 Animal restraint ................................................................................................................................................................. 7

5.2.3 Blood collection ................................................................................................................................................................... 8

5.2.4 Solid tissues ............................................................................................................................................................................ 8

5.2.5 Nail and hair ........................................................................................................................................................................... 8

5.2.6 Faecal biological material ........................................................................................................................................... 9

5.2.7 Urine .............................................................................................................................................................................................. 9

5.2.8 Milk ................................................................................................................................................................................................. 9

5.2.9 Germplasm ............................................................................................................................................................................ 10

5.2.10 Other biological materials of animal origin ............................................................................................ 10

5.2.11 Additional information .............................................................................................................................................. 10

6 Transport of biological material and associated data .............................................................................................10

7 Reception ..................................................................................................................................................................................................................11

8 Preparation and preservation of biological material ...............................................................................................11

9 Storage of biological material .............................................................................................................................................................12

10 Distribution, disposal and destruction of biological material ........................................................................12

10.1 Distribution ............................................................................................................................................................................................12

10.2 Destruction and disposal ........................................................................................................................................................... 13

11 Information collection ................................................................................................................................................................................13

Annex A (informative) Exemplary data collection table for animal biological material ..........................14

Annex B (informative) Collection methods for animals of different natures and sizes .............................16

Annex C (informative) Information in a material transfer agreement or equivalent

document ..................................................................................................................................................................................................................19

Annex D (normative) Collection, preparation and preservation methods ..............................................................20

Bibliography .............................................................................................................................................................................................................................24

iii
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ISO/TS 20388:2021(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.
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ISO/TS 20388:2021(E)
Introduction

This document contains requirements and recommendations to enable biobanks handling animal

material to demonstrate competent biobank operation and the ability to provide animal biological

material and associated data of appropriate quality for research and development.

This document supports processes that maintain animal welfare, as it is anchored in the principle of the

[18]
three Rs: to “Replace, Reduce and Refine the use of animals” .

The use of this document helps to ensure the quality of animal biological material and the reliability of

research results under the application of ISO 20387.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
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TECHNICAL SPECIFICATION ISO/TS 20388:2021(E)
Biotechnology — Biobanking — Requirements for animal
biological material
1 Scope

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

transport, storage, distribution, destruction and disposal of biological materials obtained from animals,

excluding humans. Such resources include solid tissues, fluid samples and associated cells, excretory

products and associated data.

This document is applicable to biological material or associated data, or both, that can be used for

research and development and to biomolecules derived from the biological material, e.g. nucleic acids,

proteins and metabolites.

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

This document does not apply to biological material intended for food or feed production, laboratories

undertaking analysis for food or feed production, or therapeutic use, or multiple of them.

This document does not apply to the establishment of cell lines derived from animal biological material.

NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to

specific topics covered in this document.
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
WHO. Laboratory biosafety manual. World Health Organization, 4th edition, 2020
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 20387:2018 and the following

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
animal

multicellular, heterotrophic organism, that has sensation and the power of voluntary movement, and

whose cells differ from those of most plants by the absence of cell walls
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ISO/TS 20388:2021(E)
3.2
associated data

any information affiliated with biological material (3.5) including but not limited to research,

phenotypic, clinical, epidemiologic, genetic, taxonomic, systematic and procedural data

Note 1 to entry: Associated data can include metadata.

[SOURCE: ISO 20387:2018, 3.3, modified — “genetic, taxonomic, systematic” and Note 1 to entry have

been added.]
3.3
biobank
legal entity or part of a legal entity that performs biobanking (3.4)
[SOURCE: ISO 20387:2018, 3.5]
3.4
biobanking

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

preparation, preservation (3.15), testing, analysing and distributing defined biological material (3.5) as

well as related information and data
[SOURCE: ISO 20387:2018, 3.6]
3.5
biological material

any substance derived or part obtained from an organic entity such as a human, animal (3.1), plant,

microorganism(s) or multicellular organism(s) that is(are) neither animal nor plant (e.g. brown

seaweed, fungi)

Note 1 to entry: For this document, biological material applies only to animals and derivatives thereof.

Note 2 to entry: For this document, biological material can refer to the whole animal.

[SOURCE: ISO 20387:2018, 3.7, modified — Notes 1 and 2 to entry have been added.]

3.7
biosafety

practices and controls that reduce the risk of unintentional exposure or release of biological materials

(3.5)

Note 1 to entry: The release of biological material can refer to live animals (3.1).

Note 2 to entry: This definition includes unintentional exposure, for example, to pathogens and toxins, or their

accidental release as a biosafety risk.

[SOURCE: ISO 35001:2019, 3.22, modified — Notes 1 and 2 to entry have been added.]

3.8
clean technique

non-sterile practice involving strategies used to reduce the overall contamination or to prevent or

reduce the risk of transmission of contaminants

Note 1 to entry: A clean technique can involve meticulous handwashing, preparing and maintaining an

uncontaminated environment by using uncontaminated consumables and sterile instruments, and preventing

direct contamination of materials and supplies.
3.9
destruction

process of eliminating biological material (3.5) and/or deleting associated data (3.2), beyond any

possible reconstruction
[SOURCE: ISO 20387:2018, 3.18]
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ISO/TS 20388:2021(E)
3.10
germplasm

biological material (3.5) derived from germ cells, somatic cells or stem cells used in sexual reproduction

or assisted reproductive technologies
3.11
invasive collection
any collection procedure that requires the animal (3.1) to be handled

Note 1 to entry: Most clinically acceptable sample (3.17) collection procedures are minimally invasive (e.g. buccal

swab).
3.12
life cycle

consecutive and interlinked processes applied to biological material (3.5) and associated data (3.2) from

collection, if applicable, acquisition or reception to distribution, disposal or destruction (3.9)

Note 1 to entry: This term refers to the biobanking (3.4) life cycle only.
[SOURCE: ISO 20387:2018, 3.29]
3.13
material transfer agreement
MTA

documented agreement governing the transfer of biological material (3.5) and associated data (3.2)

between a biobank (3.3) and a recipient

Note 1 to entry: An MTA document contains information about the in situ origin or the source of the biological

material and associated data, information about the provider and recipient, and information that defines the

limits of the use of the biological material and associated data.

Note 2 to entry: An MTA can also be associated with a biological material being deposited to meet the need of

its depositor country/country of origin, particularly those that are the parties of the Convention of Biological

Diversity (CBD) and Nagoya Protocol (NP).
3.14
non-invasive collection
collection procedure performed without handling the animal (3.1)
3.15
preservation

act to prevent or retard biological or physical deterioration of biological material (3.5)

[SOURCE: ISO 20387:2018, 3.34]
3.16
processing

performing any activity on biological material (3.5) and associated data (3.2) during all stages of the life

cycle (3.12)
[SOURCE: ISO 20387:2018, 3.36]
3.17
sample
portion of or the entire whole
[SOURCE: ISO 20387:2018, 3.45, modified — “or the entire” has replaced “a”.]
3.18
storage

maintenance of biological material (3.5) under specified conditions for future use

[SOURCE: ISO 20387:2018, 3.47]
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ISO/TS 20388:2021(E)
3.19
zoonosis

disease or infection that is naturally transmissible from vertebrate animals (3.1) to humans

[SOURCE: Reference [19]]
4 General requirements
4.1 General
The biobank shall follow ISO 20387.

NOTE 1 Information for the implementation of ISO 20387 is provided in ISO/TR 22758.

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

retention of any relevant documentation.

NOTE 2 Legitimate acquisition can refer to purchases, regulations, permits or authorizations.

NOTE 3 Relevant documentation can include sales receipts, import/export certificates, international treaties

and agreements, and animal health certificates or passports.

If legitimate acquisition cannot be demonstrated, the biological material and associated data shall be

disposed of according to documented procedures, and this shall be documented.
4.2 Ethical requirements

The collection of biological material from live animals shall comply with recognized animal welfare

practice. The biobank shall be aware of and able to demonstrate compliance with applicable animal

welfare requirements.
NOTE Additional guidance can be found in References [20] and [21].

The biobank shall identify and document the situations where approval by an ethics committee is

needed. ISO 20387:2018, 4.1.6, shall be followed. The biobank shall retain appropriate documents as

evidence of the approval.

The biological material or associated data, or both, should not be either accepted or distributed, or both,

if any of these is found to be non-compliant with applicable regulations.
4.3 Health and safety
4.3.1 General principles

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

conform to ISO 20387:2018, 6.2.1.5, 6.3.4 and 6.3.5.

The bio-risk management of the biobank shall be in accordance with the WHO’s Laboratory Biosafety

Manual or equivalent (e.g. ISO 35001). The biobank facility should be designed in accordance with the

WHO’s Laboratory Biosafety Manual or equivalent.

Health and safety policies shall be established, implemented, documented and reviewed with the

appropriate health and safety advisory group and fully outlined in the standard operating procedures

(SOPs) of the related processes. All factors that can have an influence on health and safety (e.g. facilities,

potential pathogens, chemicals, sharps, liquid nitrogen, dry ice, explosives, fire hazards) should be

taken into account.
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ISO/TS 20388:2021(E)

Appropriate personal protective equipment (PPE) shall be used when handling biological material of

animal origin to prevent injury or infection, or both.

NOTE Zoonosis can occur through any route such as via the respiratory passage (e.g. SARS, bird flu) or by

direct contact (e.g. rabies, yellow fever, tick borne encephalitis, West Nile virus infection).

Biobank personnel shall be under medical surveillance according to exposure and risk, as required.

All biobanking procedures in accordance with ISO 20387:2018, 4.1.1, that are used shall include

measures for prevention of unintended release of materials that are potentially harmful to human and

animal health or the environment, or both.
4.3.2 Chemical safety

The biobank shall maintain documentation of all hazardous substances used (e.g. for sample fixation

or preservation), together with the corresponding safety data sheets (SDSs) providing information on

potential hazards.

The biobank shall ensure that all handling of chemicals is undertaken in such a way as to safeguard

human health and the environment. This includes all chemicals, natural and manufactured, and the full

range of exposure situations.
4.3.3 Biosafety

The biobank should adhere to the WHO’s Laboratory Biosafety Manual or equivalent when handling

biological material contaminated with pathogens.

Personnel at risk of exposure to vaccine-preventable infectious diseases shall have appropriate

immunizations made available to them, when possible.
5 Biological material collection
5.1 Prior to collection
5.1.1 Pre-acquisition information
For pre-acquisition information, ISO 20387:2018, 7.2.2, shall be followed.

NOTE The data to be acquired depend on the different types of animal sources (e.g. livestock, laboratory,

domestic or wild animals), shown in Annex A, and the intended use, which can be described in the relevant MTA

(see Annex C).
See Clause 11 for more information, recommendations and requirements.
5.1.2 Collection plan

The biobank shall adhere to ISO 20387:2018, 7.2.3, for collection procedures and ISO 20387:2018,

7.3.2.5, for documentation.

The biobank or the recipient/user, or both, shall develop, implement and document collection procedures

for each type of biological material or associated data, or both, to maintain the quality of the biological

material(s) and to meet the fitness for the intended purpose. These procedures shall address at least

the following factors:

a) intended purpose, where known, including the criteria needed in order to meet the potential

analytical objective(s) (e.g. required viability, integrity and functionality of the animal biological

material);
b) processing method;
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ISO/TS 20388:2021(E)
c) preservation method;
d) donor identity (e.g. taxonomic level of the donor);

e) geographical or physical location, or both, of the source (e.g. donor animal, body part, excreted

material) for collection of biological material;
f) biological material or sample type and associated data;
g) body part and accessibility for collection;
h) biological material quantity or size or both (e.g. blood, urine, tissue);
i) container and suitability for storage;
j) collection tools, consumables, and equipment;

k) the date and time of collection (in a standard format, preferably in accordance with ISO 8601-1);

l) duration of collection procedure for each individual donor, if relevant;
m) collection frequency for a given donor (in cases of multiple collections);
n) sequential order of collection (e.g. if multiple organs are collected);

o) quality criteria (e.g. macroscopic aspect, colour, texture) and pre-analytical workflows in

accordance with ISO 20387:2018, 7.2.3.2;
p) competence required to undertake the procedure.

The collection procedure(s) should minimize adverse effects for the donor animal.

The targeted biological material can be obtained from a large variety of tissues (e.g. skin, nail, hair

or feather follicles, fins, scales, foot pads, fat deposits, muscle, brain, heart, lung, liver, kidney, gonads,

glands, bone, shell, placenta), biological fluids (e.g. blood, urine, milk, egg albumen, semen, cerebrospinal

fluid) or other biological materials (e.g. buccal swabs, embryos, faeces).

The biological material shall be of sufficient yield, purity, integrity and viability in order to ensure

fitness for the intended purpose.

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

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

required for each biological material collection. When practicable, this shall include but not be limited

to the following:
a) collection container(s) and seal(s);

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

tools such as cutting devices, instruments, containers and reagents;

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

c) ink, labels or tags, when not integral to the container(s);
d) collection instruments;
e) collection consumables;
f) PPE;
g) information recording tools;
h) reminder systems (e.g. checklists).
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ISO/TS 20388:2021(E)

The tools for collection (e.g. instruments, consumables, PPE) should be prepared and checked prior to

collection. Preparing a checklist before collection can help to ensure an uninterrupted and efficient

procedure.

Leak-proof cryotubes with secure screw top lids or straws with seals can be used for samples that

will be stored in liquid nitrogen or in freezers. Plastic bags should be avoided when storing biological

material at temperatures below −20 °C.

Single-use consumables shall not be re-used, whenever possible, and shall be appropriately disposed of.

Whenever single-use consumables are re-used this shall be documented.

Documented procedures to clean and, when necessary, disinfect non-disposable instruments used in

collection (e.g. skin sampler, ear puncher, scissors, scalpel) and the relevant work area between uses

shall be implemented to avoid cross-contamination or infection, or both.

Measures shall be taken to avoid contamination by RNase in the environment, if the analytical objective

is RNA extraction or use. The same precaution shall be applied for other analytical objectives.

The biological material shall be appropriately tagged at collection in accordance with ISO 20387:2018,

7.5.1, a).
5.2 Collection
5.2.1 General

Unnecessary destructive or lethal injury to the animal during collection from live animals shall

be avoided, where possible. If accidental or unnecessary destructive or lethal injury occurs during

collection, it shall be documented.
Where collection is lethal, the biobank shall use a documented procedure that:
a) minimizes fear and distress;
b) achieves rapid unconsciousness or death;
c) is suitable for the age, species and health condition of the donor;
d) is reliable and simple to administer;
e) is safe for biobank personnel.

For road-kill or field-acquired dead donors, the biobank can consider alternative collection techniques

including freezing (of the whole donor or a part) for downstream research purposes.

5.2.2 Animal restraint

The biobank shall establish, document and implement an animal restraint procedure to avoid or

minimize discomfort, distress and pain to the animal during restraint including the following:

a) The duration of the hold or restraint should be as short as feasible for the collection, in order to

minimize donor distr
...

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