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BS ISO 24603:2022

BS ISO 24603:2022

$167.15

Biotechnology. Biobanking. Requirements for human and mouse pluripotent stem cells

Published By Publication Date Number of Pages
BSI 2022 38
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PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
13 4 Abbreviated terms
14 5 General requirements
5.1 General
5.2 Legal and ethical requirements
5.3 Personnel, facilities and equipment
15 5.4 Reagents, consumables and other supplies
5.5 Management of information and data
16 6 Collection of biological source materials and associated data
6.1 Information about the human donor and requirements for the biological material
6.2 Information about the mouse donor and requirements for the biological material
17 6.3 Collection procedure
7 Transport of the biological source material or PSCs and associated data to the biobank
18 8 Reception and traceability of the biological source material or PSCs and associated data
9 Establishment of cell lines
9.1 Processes
9.2 Unique identification
9.3 Testing for infectious agents
19 10 Characterization
10.1 General
20 10.2 Population doubling time and subculture/passage
10.2.1 PDT
21 10.2.2 Subculture/passage
10.3 Stability of the culture
22 10.4 Functionality
10.4.1 General
10.4.2 In vitro differentiation
10.5 Microbial contamination
11 Quality control
23 12 Testing
13 Cell line management
14 Preservation of cell lines
24 15 Storage
16 Thawing
25 17 Disposal
18 Distribution
18.1 General requirements
18.2 Information for users
26 18.3 Transport
29 Annex A (informative) Potency comparison
30 Annex B (informative) Examples for methods for the establishment and culture of PSCs
34 Annex C (informative) Quality control procedure for biobanking of human and mouse PSCs
35 Bibliography

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BS ISO 24603:2022
$167.15