GB/T 12715-1991
Abolished
T/SDSBME 002-2024
Active
Group standards
T/SDSBME 002-2024 Exosome preparation and application from umbilical cord mesenchymal stem cells
T/SDSBME 002-2024 Exosome preparation and application from umbilical cord mesenchymal stem cells
Price:
$ 20.00
Basic Information
Standard Code:
T/SDSBME 002-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Biology, botany, and zoology
Publish Date:
2024-09-20
Implement Date:
2024-09-20
Scope
Main technical content: In order to guide and standardize the preparation and application of exosomes derived from umbilical cord mesenchymal stem cells, and promote the healthy development of the exosome industry, this document is formulated with reference to the "General Requirements for Stem Cells", the "Group Standard for Human Mesencephalic Dopaminergic Neuron Precursor Cells", the "Good Manufacturing Practice for Pharmaceutical Products", and the "Self-Discipline Standards for Quality Management of Stem Cell Preparations", in accordance with laws and regulations such as the "Drug Administration Law of the People's Republic of China", the "Pharmacopoeia of the People's Republic of China", and the "National Clinical Laboratory Operation Guidelines". This document aims to provide unified technical guidance and standards for the preparation and application of exosomes derived from umbilical cord mesenchymal stem cells, ensuring their safety, effectiveness, and reliability. In terms of implementation, this document will encourage relevant units to actively participate in the formulation and promotion of standards, and jointly promote technological progress and standardization in this field. This document specifies the identification methods, testing requirements, testing rules, labeling, packaging, storage, transportation, and waste disposal requirements for exosomes derived from umbilical cord mesenchymal stem cells.