GB 12264-1990
Replaced
YY/T 1598-2018
Active
Industry standards-Medicine
YY/T 1598-2018 Tissue engineering medical device products—Bone:Standard guide for bone repairing or regenerative evaluation of implant for spinal fusion
YY/T 1598-2018 Tissue engineering medical device products—Bone:Standard guide for bone repairing or regenerative evaluation of implant for spinal fusion
Basic Information
Standard Code:
YY/T 1598-2018
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:
2018-04-11
Implement Date:
2019-05-01
Pages:
16 pages
Scope
This standard provides guidelines for in vivo bone repair or regeneration evaluation trials prior to the clinical application of implants for spinal fusion. This standard is applicable to tissue engineering medical device products used for surgical implants in spinal fusion.
Development Information
Referenced Standards
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
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