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

Publish Date: 2016-07-29 Implement Date: 2017-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 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

Word Count: 14 Thousand words Pages: 8 pages

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

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