YY/T 1680-2020: Allogeneic Grafts - In Vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone

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Scope

This Standard provides methods and guidelines for evaluating the effectiveness of
allogeneic demineralized bone products in causing or promoting bone formation when
implanted (or injected) into the human body.
This Standard is applicable to the evaluation of osteoinductive performance of
demineralized bone and medical device products containing demineralized bone.
NOTE: Bone implants containing human gene recombinant BMP protein can also refer to this
Standard for the evaluation of in vivo osteoinductive performance.

Basic Data

Standard ID	YY/T 1680-2020 (YY/T1680-2020)
Description (Translated English)	Allogeneic Grafts - In Vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	10,132
Date of Issue	2020
Date of Implementation	2021-01-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies methods and guidelines for evaluating the effectiveness of allogeneic demineralized bone products in causing or promoting bone formation when implanted (or injected) into the human body. This standard applies to the evaluation of osteogenic induction performance of demineralized bone and medical device products containing demineralized bone.