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eLibrary > BS ISO 21709:2020+A1:2021 Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines >

BS ISO 21709:2020+A1:2021 Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines, 2021

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BS ISO 21709:2020+A1:2021 Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines, 2021

National foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements [Go to Page]
4.1 General
4.2 Legal and ethical requirements
4.3 Facilities [Go to Page]
4.3.1 General
4.3.2 Cell culture facility
4.4 Equipment [Go to Page]
4.4.1 General
4.4.2 Equipment inspection
4.5 Reagents
4.6 Personnel [Go to Page]
4.6.1 General
4.6.2 Personnel competence
4.6.3 Personnel training
4.6.4 Biorisk and biosafety of personnel
5 Process requirements [Go to Page]
5.1 Establishment of cell lines within the biobank [Go to Page]
5.1.1 General
5.1.2 Isolation and purification of primary cells
5.1.3 Primary cultures
5.1.4 Cell lines
5.2 Reception of established cell lines [Go to Page]
5.2.1 General
5.2.2 Review of the deposit request
5.2.3 Decision on the deposit request
5.2.4 Transfer of material and associated data
5.2.5 Characterization and authentication of the cell line
5.2.6 Assignment of accession number
5.3 Cell line management [Go to Page]
5.3.1 Planning for cell banking
5.3.2 Accession
5.3.3 Propagation of cell lines
5.3.4 Preservation and storage
5.3.5 Inventory management
5.3.6 Disposal management
5.4 Distribution [Go to Page]
5.4.1 General
5.4.2 Acceptance of order request
5.4.3 Distribution review
5.4.4 Transport
5.5 Quality control, validation and verification [Go to Page]
5.5.1 Quality control
5.5.2 Validation and verification
6 Performance evaluation and improvement
Annex A (informative) Recommended units for biobanking of cell lines
Bibliography [Go to Page]

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BS ISO 21709:2020+A1:2021 Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines, 2021

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