ISO/TS 20388:2021
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.
NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General
4.2 Ethical requirements
4.3 Health and safety
4.3.1 General principles
4.3.2 Chemical safety
4.3.3 Biosafety
5 Biological material collection
5.1 Prior to collection
5.1.1 Pre-acquisition information
5.1.2 Collection plan
5.1.3 Preparation of collection containers, tools, supplies, reagents and consumables
5.2 Collection
5.2.1 General
5.2.2 Animal restraint
5.2.3 Blood collection
5.2.4 Solid tissues
5.2.5 Nail and hair
5.2.6 Faecal biological material
5.2.7 Urine
5.2.8 Milk
5.2.9 Germplasm
5.2.10 Other biological materials of animal origin
5.2.11 Additional information
6 Transport of biological material and associated data
7 Reception
8 Preparation and preservation of biological material
9 Storage of biological material
10 Distribution, disposal and destruction of biological material
10.1 Distribution
10.2 Destruction and disposal
11 Information collection
Annex A (informative) Exemplary data collection table for animal biological material
Annex B (informative) Collection methods for animals of different natures and sizes
Annex C (informative) Information in a material transfer agreement or equivalent document
Annex D (normative) Collection, preparation and preservation methods
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General
4.2 Ethical requirements
4.3 Health and safety
4.3.1 General principles
4.3.2 Chemical safety
4.3.3 Biosafety
5 Biological material collection
5.1 Prior to collection
5.1.1 Pre-acquisition information
5.1.2 Collection plan
5.1.3 Preparation of collection containers, tools, supplies, reagents and consumables
5.2 Collection
5.2.1 General
5.2.2 Animal restraint
5.2.3 Blood collection
5.2.4 Solid tissues
5.2.5 Nail and hair
5.2.6 Faecal biological material
5.2.7 Urine
5.2.8 Milk
5.2.9 Germplasm
5.2.10 Other biological materials of animal origin
5.2.11 Additional information
6 Transport of biological material and associated data
7 Reception
8 Preparation and preservation of biological material
9 Storage of biological material
10 Distribution, disposal and destruction of biological material
10.1 Distribution
10.2 Destruction and disposal
11 Information collection
Annex A (informative) Exemplary data collection table for animal biological material
Annex B (informative) Collection methods for animals of different natures and sizes
Annex C (informative) Information in a material transfer agreement or equivalent document
Annex D (normative) Collection, preparation and preservation methods
Bibliography