GB 12264-1990
Replaced
YY/T 1680-2020
Active
Industry standards-Medicine
YY/T 1680-2020 Allogeneic grafts—In vivo evaluation of osteoinductive potential for materials containing demineralized bone
YY/T 1680-2020 Allogeneic grafts—In vivo evaluation of osteoinductive potential for materials containing demineralized bone
Basic Information
Standard Code:
YY/T 1680-2020
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:
2020-02-21
Implement Date:
2021-01-01
Pages:
10 pages
Scope
This standard provides an evaluation method and guidelines for assessing the effectiveness of allogeneic demineralized bone products in inducing or promoting bone formation when implanted (or injected) into the human body.
This standard applies to the evaluation of the osteogenic induction performance of demineralized bone and medical device products containing demineralized bone.
Note: Bone implants containing human recombinant BMP proteins can also refer to this standard for in vivo osteogenic induction performance evaluation.
Development Information
Referenced Standards
GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
YY/T 0513.3-2020 Allogeneic grafts—Part 3:Demineralized bone grafts
GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced