GB/T 12715-1991
Abolished
T/CIQA 100-2024
Active
Group standards
T/CIQA 100-2024 The standard for preparation and testing of cells derived from odontogenic stem cell-derived extracellular vesicles
T/CIQA 100-2024 The standard for preparation and testing of cells derived from odontogenic stem cell-derived extracellular vesicles
Price:
$ 20.00
Basic Information
Standard Code:
T/CIQA 100-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Basic disciplines
ICS Name:
Biology, botany, and zoology
Publish Date:
2024-11-07
Implement Date:
2024-11-07
Scope
Main technical content: 1. Dental-derived stem cells 1.1 Preparation of dental-derived stem cells 1.2 Quality control of dental-derived stem cells 1.3 Dental-derived stem cell bank 2. Technical requirements 2.1 Preparation of extracellular vesicles 2.1.1 Preparation process 2.1.2 Raw materials 2.1.3 Collection of stem cell culture medium 2.1.4 Separation and concentration 2.2 Key quality attributes 2.2.1 Quality testing items for extracellular vesicles 2.2.2 Impurities 2.2.3 Identification 2.2.4 Physicochemical properties 2.2.5 Safety 2.2.6 Purity 3. Testing methods 3.1 Impurities 3.1.1 Visible foreign matter 3.2 Identification 3.2.1 Morphology 3.2.2 Particle size 3.2.3 Marker proteins 3.3 Physicochemical properties 3.3.1 pH value 3.3.2 Osmolality 3.4 Safety 3.4.1 Sterility (bacteria, fungi) 3.4.2 Mycoplasma 3.4.3 Bacterial endotoxins 3.4.4 Intracellular and extracellular viral factors 3.4.5 Carcinogenicity 3.5 Purity 3.5.1 Protein concentration 3.5.2 Particle concentration