YY/T 0606.25-2014 Tissue engineered medical product—Part 25:Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
YY/T 0606.25-2014 Tissue engineered medical product—Part 25:Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
Basic Information
Scope
This part of YY/T 0606 is applicable to the final or intermediate products of animal-derived biomaterials and their derivatives, as well as animal-derived scaffold materials used in tissue engineering medical products. It can also be used for human-derived materials.
The test methods described in this part are used for the quantitative detection of residual DNA in animal-derived biomaterials. The detection results of the DNA residues in the samples to be tested are valid within the detection sensitivity of the methods described in this part. For each specific sample, it is necessary to have appropriate methodological verification to determine whether the settings of the test conditions are reasonable. In addition to the methods selected in this standard, other equivalent methods can be adopted.
Users implementing this part should establish corresponding safety and health regulations and stipulate the applicability of management regulations.