GB 12264-1990
Replaced
YY/T 1502-2016
Active
Industry standards-Medicine
YY/T 1502-2016 Spinal implants—Intervertebral body fusion devices
YY/T 1502-2016 Spinal implants—Intervertebral body fusion devices
Basic Information
Standard Code:
YY/T 1502-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2016-07-29
Implement Date:
2017-06-01
Pages:
8 pages
Scope
This standard specifies the terms and definitions, expected performance, design attributes, materials, pre-clinical evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer for interbody fusion devices.
This standard applies to interbody fusion devices placed between adjacent vertebrae to support the fusion of two vertebrae.
This standard applies to interbody fusion devices made from metal and polymer materials, but does not apply to drug-device combination products (such as interbody fusion devices using bone morphogenetic protein).
Development Information
Referenced Standards
YY/T 0640-2008 Non-active surgical implants—General requirements
GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 10610-1998 Geometrical product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
GB/T 13810-1997 Wrought titanium and titanium alloy for surgical implants
GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants
GB/T 13810-2017 Wrought titanium and titanium alloy for surgical implants
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
GB 23102-2008 Implants for surgery—Metallic materials—Wrought titanium-6aluminium-7niobium alloy
YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants
YY/T 0586-2005 Medical polymer products—Test methods of radiopacity
YY/T 0586-2016 Medical polymer products-Test methods of radiopacity
YY/T 0660-2008 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications
YY/T 0959-2014 Spinal implants—Test methods for mechanical property of intervertebral body fusion devices
YY/T 0960-2014 Spinal implants—Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression
YY/T 0966-2014 Implants for surgery—Metallic materials—Unalloyed tantalum
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