ISO 16677-1:2025
(Main)Biobanking — Germplasm — Part 1: Agricultural animal species
Biobanking — Germplasm — Part 1: Agricultural animal species
This document specifies requirements for the biobanking of animal germplasm, e.g. semen, embryos, oocytes, gonads and related tissue, including reception, preparation, quality control, storage and distribution. This document is applicable to animal species for food and agriculture. This document is applicable to all organizations performing biobanking of animal biological material and associated data, such as public or private gene banks and germplasm livestock collections centres. NOTE International, national or regional regulations or requirements, or combinations of them, can also apply to specific topics covered in this document.
Biobanques — Germoplasme — Partie 1: Espèces animales agricoles
General Information
Standards Content (Sample)
International
Standard
ISO 16677-1
First edition
Biobanking — Germplasm —
2025-01
Part 1:
Agricultural animal species
Biobanques — Germoplasme —
Partie 1: Espèces animales agricoles
Reference number
© ISO 2025
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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 . 3
4.1 General .3
4.2 Legal and ethical .4
4.2.1 General .4
4.2.2 Animal welfare .4
4.3 Health and safety . .4
4.3.1 General .4
4.3.2 Personnel safety .5
4.3.3 Chemical safety .5
5 Reception . 5
6 Preparation and cryopreservation . 5
7 Storage . 6
8 Distribution . 6
9 Management of information and data . 7
Annex A (informative) Examples of evidence of compliance . 8
Annex B (informative) Potential elements to consider for storage processes . 9
Annex C (informative) Germplasm quality control . 10
Bibliography .11
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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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 document 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).
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This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 16,
Horizontal methods for molecular biomarker analysis, in collaboration with Technical Committee ISO/TC 276,
Biotechnology.
A list of all parts in the ISO 16677 series can be found on the ISO website.
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
The protection of the genetic biodiversity of all living species is globally important. Although there is
considerable social, economic and scientific guidance at the national and international levels, including
protocols and treaties regulating the movement and development of species, these do not provide practical
documents for individuals and organizations to ensure the stability of the future of genetic resource
management. Biobanking germplasm is a major component of conserving animal genetic resources.
[1]
Effectively constructing such biobanks requires the ability to conserve various germplasms through
cryopreservation, a robust information technology infrastructure and an understanding of how to evaluate
[2]
genetic resources to facilitate use of the collection.
A variety of animal genetic resource collections exist worldwide, as can be seen in the Domestic Animal
Diversity Information System (DAD-IS) from the Food and Agriculture Organization (FAO) of the United
Nations, performing a wide range of biobank activities for the short- and long-term needs of research
[3]
communities and industry. Animal biobanking is a comprehensive and dynamic process that can span
[4]
decades of continued sample curation and evaluation of the collection, while projecting future needs .
The goal of a germplasm biobank is to provide society with a broad range of genetic options for different
types of future use. Within the agricultural sector, the maintenance of sufficient genetic diversity of animal
germplasm for future use faces challenges (e.g. low number of national and regional biobanks, animal
[5][6]
health restrictions, lack of technology for wild species). Therefore, stakeholder engagement can help to
[7]
determine the scope of biobank activities and associated strategies to support food security.
This document provides guidance for animal germplasm biobanks that can be used for the conservation of
animal genetic resources for food and agriculture, and harmonization of strategy to capture the existing
[6][8]
genetic diversity for future use.
v
International Standard ISO 16677-1:2025(en)
Biobanking — Germplasm —
Part 1:
Agricultural animal species
1 Scope
This document specifies requirements for the biobanking of animal germplasm, e.g. semen, embryos, oocytes,
gonads and related tissue, including reception, preparation, quality control, storage and distribution.
This document is applicable to animal species for food and agriculture.
This document is applicable to all organizations performing biobanking of animal biological material and
associated data, such as public or private gene banks and germplasm livestock collections centres.
NOTE International, national or regional regulations or requirements, or combinations 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
ISO/TS 20388:2021, Biotechnology — Biobanking — Requirements for animal biological material
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 20387 and the following apply.
ISO and IEC maintain 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
agricultural animal species
all animal populations used for food and agricultural production
3.2
associated data
any information affiliated with biological material (3.6) including but not limited to research, phenotypic,
clinical, epidemiologic, genetic, taxonomic, systematic, geographic location and procedural data
Note 1 to entry: Associated data can include metadata.
[SOURCE: ISO 20387:2018, 3.3, modified — “genetic, taxonomic, systematic, geographic location” and Note 1
to entry added.]
3.3
biobank
legal entity or part of a legal entity that performs biobanking (3.4)
3.4
biobanking
set of activities, including acquisition, storage (3.15) and retrieval of defined biological material (3.6) and
associated data (3.2), with the potential inclusion of one or more of the following: collection, processing
(3.13), preservation, testing, analysis, distribution, destruction and disposal
3.5
biodiversity
variability among living organisms on the earth, including the variability within and between species, and
within and between ecosystems
3.6
biological material
any substance derived or part obtained from an organic entity such as a human, animal, plant,
microorganism(s) or multicellular organism(s) that is(are) neither animal or 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 added.]
3.7
biosafety
practices and controls that reduce the risk of unintentional exposure or release of biological materials (3.6)
[9]
[SOURCE: ISO 35001:2019 , 3.22]
3.8
cryopreservation
act to prevent or retard biological or physical deterioration of biological material (3.6)
[SOURCE: ISO 20387:2018, 3.34, modified — “cryopreservation” replaced “preservation”.]
3.9
donor
organic entity, such as a human, animal, plant, etc., from which the biological material (3.6) and/or associated
data (3.2) is collected for biobanking (3.4)
3.10
genetic resources
genetic material containing functional units of heredity (e.g. DNA o
...
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