ISO/NP 7614.2

Tissue-engineered medical products — The method for quantification of residual DNA in decellularized ECM scaffolds ISO/NP 7614.2

Scope

This standard provides a method for quantification of residual DNA contained in decellularized extracellular matrix (ECM) materials which are biological-origin materials, such as animal-origin, as well as human original materials.

The method described in this standard is intended to be used for scaffolds of tissue-engineered medical products (TEMPs), as well as the final finished products or semi-finished products, which are consist of decellularized ECM materials.