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.

Biotechnologie — Banques biologiques — Exigences relatives au matériel biologique animal

General Information

• Status: Published
• Publication Date: 02-Dec-2021
• ICS: 07.080 - Biology. Botany. Zoology
• Technical Committee: ISO/TC 276 - Biotechnology
• Drafting Committee: ISO/TC 276/WG 2 - Biobanks and bioresources
• Current Stage: 6060 - International Standard published
• Start Date: 03-Dec-2021
• Due Date: 14-Dec-2021
• Completion Date: 03-Dec-2021

Standards Content (Sample)

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
ii
  © 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 .
...