Standard No.:	YY/T 0606.25-2014
English Name:	Tissue engineered medical product―Part 25:Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
Chinese Name:	组织工程医疗产品 第25部分 动物源性生物材料DNA残留量测定法：荧光染色法
Chinese Classification:	C45    Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2014-06-17
Implemented on:	2015-7-1
Status:	superseded
Superseded by:	YY/T 1876-2023 Tissue engineered medical products--Quantification of remnant DNA in biologicalmaterials utilizing animal tissues and their derivatives : Fluorescence method
Superseded on:	2024-1-15
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	200.0
Delivery:	via email in 1~3 business day

本标准适用于动物源性生物材料及其衍生物的终产品或中间产品、组织工程医疗产品基质或支架的动物源性支架材料。
本标准所述试验方法用于动物源性生物材料的残留DNA定量检测。待检测样品的DNA残留量在本标准所述方法的检测灵敏度之内的检测结果有效。针对每一特定的样品，试验条件的设定是否合理需要有适当的方法学验证。除本标准所选方法外，可采纳其他等效方法。
实施本标准的使用者应建立相应的安全和健康条例，并规定管理条例的适用性。