YY/T 1876-2023: Tissue engineered medical products - Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives - Fluorescence method

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Scope

This document specifies a method for the determination of remnant DNA in biological
materials utilizing animal tissues and their derivatives.
This document applies to final products or intermediate products of biological materials
utilizing animal tissues and their derivatives, scaffold materials utilizing animal tissues
and their derivatives used as matrices or scaffolds for tissue engineered medical
products, and can also be used for human-derived decellularized matrix materials.

Basic Data

Standard ID	YY/T 1876-2023 (YY/T1876-2023)
Description (Translated English)	(Tissue-engineered medical products-Determination of DNA residues in biological materials of animal origin: fluorescent staining)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of International Standard	11.040.30
Word Count Estimation	13,134
Date of Issue	2023-01-13
Date of Implementation	2024-01-15
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the method for the determination of DNA residues in biological materials of animal origin. This standard applies to the final or intermediate products of animal-derived biological materials and their derivatives, animal-derived scaffold materials used for tissue engineering medical product matrices or scaffolds, and human-derived decellularized matrix materials.