YY/T 1575-2017 Active Industry standards-Medicine

YY/T 1575-2017 Tissue engineering medical device products—Standard guide for in vivo assessment of implantable devices intended to repair or regenerate bone defect

Publish Date: 2017-08-18 Implement Date: 2018-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1575-2017

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: 2017-08-18

Implement Date: 2018-09-01

Pages: 15 pages

Scope

This standard specifies the general principles for in vivo evaluation of the osteogenic activity of implants used to repair and replace bone tissue defects. The implants described in this standard may be composed of natural or synthetic biomaterials (biodegradable), or their composites.
This standard describes animal models of different species such as rats, rabbits, dogs, pigs, and sheep, and the corresponding experimental procedures, as well as methods for determining and evaluating results such as morphological, histochemical, and biomechanical analyses.
This standard applies to implants used to repair and replace bone tissue defects.