ISO/TS 20388:2021

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 2021
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ii
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
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
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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
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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
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.
v
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
...