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BS ISO 21709:2020

BS ISO 21709:2020

$142.49

Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines

Published By Publication Date Number of Pages
BSI 2020 28
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This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. It describes requirements for the fundamental procedures of the biobank handling cell lines, such as establishment, reception, identification, propagation, preservation, storage, quality control, and distribution of cell lines.

This document can be used by organizations performing biobanking activities with mammalian cell lines used for research and development, biobank users, organizations and schemes using peer-assessment and accreditation bodies.

This document does not apply to biological material intended for therapeutic use.

NOTE

International, national or regional regulations or requirements can also apply to specific topics covered in this document.

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Requirements
4.1 General
4.2 Legal and ethical requirements
12 4.3 Facilities
4.3.1 General
4.3.2 Cell culture facility
4.4 Equipment
4.4.1 General
13 4.4.2 Equipment inspection
14 4.5 Reagents
4.6 Informed consent
4.6.1 General
4.6.2 Procedure of obtaining informed consent
15 4.6.3 Special circumstances for informed consent
4.6.4 Information provided to the donor/patient or the donor’s/patient’s legally designated or nominated representative
16 4.6.5 Informed consent signature
4.7 Personnel
4.7.1 General
4.7.2 Personnel competence
17 4.7.3 Personnel training
4.7.4 Biorisk and biosafety of personnel
5 Process requirements
5.1 Establishment of cell lines within the biobank
5.1.1 General
18 5.1.2 Isolation and purification of primary cells
5.1.3 Primary cultures
5.1.4 Cell lines
19 5.2 Reception of established cell lines
5.2.1 General
5.2.2 Review of the deposit request
5.2.3 Decision on the deposit request
20 5.2.4 Transfer of material and associated data
5.2.5 Characterization and authentication of the cell line
21 5.2.6 Assignment of accession number
5.3 Cell line management
5.3.1 Planning for cell banking
22 5.3.2 Accession
5.3.3 Propagation of cell lines
23 5.3.4 Preservation and storage
5.3.5 Inventory management
5.3.6 Disposal management
24 5.4 Distribution
5.4.1 General
5.4.2 Acceptance of order request
5.4.3 Distribution review
5.4.4 Transport
25 5.5 Quality control, validation and verification
5.5.1 Quality control
5.5.2 Validation and verification
6 Performance evaluation and improvement
26 Annex A (informative) Recommended units for biobanking of cell lines
27 Bibliography

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BS ISO 21709:2020
$142.49