ISO 20012:2026 — Biobanking: NK cells derived from pluripotent stem cells
Requirements for the banking of human natural killer (NK) cells derived from pluripotent stem cells, for research use: differentiation, culture, characterization, quality control, storage, thawing and transport.
- control points
- 64
- anchored clauses
- 28
- Clauses covered
- 10
Clauses covered
| General requirements (Clause 5) | 5 | 5.1 · 5.2 · 5.3 · 5.4 · 5.5 |
| hPSCs and associated data (Clause 6) | 1 | 6 |
| Generation of hPSC-NK cells (Clause 7) | 5 | 7.1 · 7.2 · 7.3 · 7.4 · 7.5 |
| Characterization of hPSC-NK cells (Clause 8) | 8 | 8.1 · 8.2 · 8.3 · 8.4 · 8.5 · 8.6 · 8.7 · 8.8 |
| Quality control (Clause 9) | 1 | 9 |
| Storage (Clause 10) | 2 | 10.1 · 10.5 |
| Thawing and culture (Clause 11) | 1 | 11 |
| Disposal (Clause 12) | 1 | 12 |
| Distribution — user information (Clause 13) | 1 | 13 |
| Transport of hPSC-NK cells (Clause 14) | 3 | 14.1 · 14.2 · 14.3 |
Scale
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