T/SDHCST 004-2021
Technical conditions and requirements for human umbilical cord/placental mesenchymal stem cell products (English Version)

Standard No.

T/SDHCST 004-2021

Language

Chinese, Available in English version

Release Date

2021

Published By

Group Standards of the People's Republic of China

Status

Be replaced 2022-05

Replace By

T/SDHCST 004-2022

Latest

T/SDHCST 004-2023

Scope

This standard specifies the terms and definitions, symbols and abbreviations, requirements, test methods, inspection rules, marking, packaging, transportation and storage requirements for mesenchymal stem cell products. This standard applies to the preparation of human umbilical cord/placenta mesenchymal stem cell products.

T/SDHCST 004-2021 history

• 2023 T/SDHCST 004-2023 Animal Species and Model Selection for Non-clinical Studies of the Cell Therapy Medical Products
• 2022 T/SDHCST 004-2022 Technical Specification for Artificially Induced Pluripotent Stem Cells
• 2021 T/SDHCST 004-2021 Technical conditions and requirements for human umbilical cord/placental mesenchymal stem cell products
• 2019 T/SDHCST 004-2019 CTCs Testing and Consultation Center Regulations
• 2018 T/SDHCST 004-2018 Standards for the storage and configuration of Medicines in Well-off level Township Hospitals