T/CSCB 0015-2022 General Requirements for the Preparation of Extracellular Vesicles Derived from Human Stem Cells
T/CSCB 0015-2022
Basic Information
Scope
Scope: This document specifies the general requirements, process requirements, packaging and labeling requirements, and storage requirements for the preparation of extracellular vesicles from human stem cells, and describes the corresponding verification methods. This document is applicable to the research and production of extracellular vesicles derived from human embryonic stem cells, human mesenchymal stem cells, human induced pluripotent stem cells, and other human stem cells. Main technical content: Foreword 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Abbreviations 5. General requirements 6. Process requirements 7. Packaging and labeling requirements 8. Storage requirements 9. Information and data management Appendix A (informative) Main parameters of Class A clean areas Appendix B (informative) Example of preparation procedures for extracellular vesicles derived from human stem cells References