TABLE 2.
Representative ISO standards regarding stem cell research and clinical translation
| Standards | Status |
|---|---|
| ISO 13022:2012 Medical Products Containing Viable Human Cells—Application of Risk Management and Requirements for Processing Practices | Published |
| ISO 20387:2018 Biotechnology‐Biobanking—General Requirements for Biobanking | Published |
| ISO 20391‐1:2018 Biotechnology—Cell Counting—Part 1: General Guidance on Cell Counting Methods | Published |
| ISO 20391‐2:2019 Biotechnology—Cell Counting—Part 2: Experimental Design and Statistical Analysis to Quantify Counting Method Performance | Published |
| ISO/TS 20399‐1:2018 Biotechnology—Ancillary Materials Present During the Production of Cellular Therapeutic Products—Part 1: General Requirements | Published |
| ISO/TS 20399–2:2018 Biotechnology—Ancillary Materials Present During the Production of Cellular Therapeutic Products—Part 2: Best Practice Guidance for Ancillary Material Suppliers | Published |
| ISO/TS 20399‐3:2018 Biotechnology—Ancillary Materials Present During the Production of Cellular Therapeutic Products—Part 3: Best Practice Guidance for Ancillary Material Users | Published |
| ISO 21709:2020 Biotechnology—Biobanking—Process and Quality Requirements for Establishment, Maintenance and Characterization of Mammalian Cell Lines | Published |
| ISO 21973:2020 Biotechnology—General Requirements for Transportation of Cells for Therapeutic Use | Published |
| ISO 21899:2020 Biotechnology—Biobanking—General Requirements for the Validation and Verification of Processing Methods for Biological Material in Biobanks | Published |
| ISO 23033:2021 Biotechnology—Analytical methods—General Requirements and Considerations for the Testing and Characterization of Cellular Therapeutic Products | Published |
| ISO/CD 20399 Biotechnology—Ancillary Materials Present During the Production of Cellular Therapeutic Products and Gene Therapy Products | Under development |
| ISO/CD 20404 Biotechnology—Bioprocessing—General Requirements for the Design of Packaging to Contain Cells for Therapeutic Use | Under development |
| ISO/DTS 22859 Biotechnology—Biobanking—Requirements for Human Mesenchymal Stromal Cells Derived from Umbilical Cord Tissue | Under development |
| ISO/CD 23511 Biotechnology—General Requirements for Cell Line Authentication | Under development |
| ISO/TS 23565 Biotechnology—Bioprocessing—General Requirements and Considerations for Equipment Systems Used in the Manufacturing of Cells for Therapeutic Use | Under development |
| ISO/DIS 24603 Biotechnology—Biobanking—Requirements for Human and Mouse Pluripotent Stem Cells | Under development |
| ISO/DIS 24651 Biotechnology—Biobanking—Requirements for Human Mesenchymal Stromal Cells Derived from Bone Marrow | Under development |