ISO/NP 25331

Biotechnology — Reference data distribution of human mesenchymal stromal cells

Scope

This document specifies general requirements for the development and distribution of human mesenchymal stromal cells (hMSCs) reference data interfaces (RDIs). This document covers:
a) hMSCs related reference data;
b) hMSCs reference data transmission;
c) distribution models;
d) related mainstream technologies;
e) logical models;
f) physical implementation models;
g) hMSCs reference data management (data storage and data security);
h) service quality control.

This document does not apply to hMSCs for the purpose of in vivo application in humans, clinical applications or therapeutic use.

NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.