YY/T 1679-2021 Active Industry standards-Medicine

YY/T 1679-2021 Tissue engineering medical device products—Bone—Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects

Publish Date: 2021-03-09 Implement Date: 2022-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1679-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2021-03-09

Implement Date: 2022-04-01

Pages: 28 pages

Scope

This standard specifies the general principles for evaluating the in vivo osteogenic activity of implants intended for repairing or regenerating bone tissue in critical-sized bone defects; it also provides relevant parameters for the preparation of animal models of bone defects, the location and extent of bone defects, the types of defects, and the preparation and evaluation of implants.
This standard is applicable to the preparation of models of partial critical-sized bone defects, as well as the rational use of models of critical-sized bone defects for testing and evaluating medical products of bone tissue engineering that induce or promote bone growth.