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YY/T 1428-2016: Spinal implants. Relevant terms
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YY/T 1428-2016
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Basic data | Standard ID | YY/T 1428-2016 (YY/T1428-2016) | | Description (Translated English) | Spinal implants. Relevant terms | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,18 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the basic terms and definitions in spinal implants and their mechanical analysis. | YY/T 1428-2016: Spinal implants. Relevant terms---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Spinal implants.Relevant terms
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Spine implants related terms
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface I
1 Scope 1
2 terms and definitions
3 Coordinate system associated with spinal implants 5
Appendix A (informative) Principle 6
Reference 7
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the re-drafting method to refer to ASTM F1582-11 "Spinal Implants Related Terms".
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Surgical Implantation and Orthopedic Equipment Standardization Technical Committee Orthopedic Implants Sub-Technical Committee (SAC/TC110 /
SC1).
The drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, the State Food and Drug Administration
General Administration of Medical Devices Technical Review Center.
The main drafters of this standard. Ma Jinzhu, Jing Ming, Li Jia, Zhang Wenhui, Liu Bin, Dong Wenxing.
Spine implants related terms
1 Scope
This standard includes basic terms and definitions in spinal implants and their mechanical analysis.
2 terms and definitions
2.1 Terms and definitions of spinal implants
2.1.1
Anchor
Directly connected to the spine (sacrum, lamina, pedicle, vertebral body, spinous process, transverse process, articular process), pelvic or ribs.
2.1.2
Tied band
Non-circular cross-section of the easy-bending anchor, through the knot or other similar locking closed-loop bundling mechanism to the spine, pelvis or rib bone
The structures are interconnected or attached to other implants.
2.1.3
Bolt bolt
By threading the anchors connected to the bony structure of the spine, pelvis or ribs, the thread lead can accommodate a nut so that the bone or
The accessory parts are sandwiched between nuts or washers and bolt heads or other fixed stops.
2.1.4
Expansion anchor
Once inserted into the bony structure will be expanded, through this mechanism to connect to the bony structure of the components.
2.1.5
Hook hook
Through the curved blade connected to the spine of the anchor, the blade connected to the lamina, transverse process or spinous process, or into the physiological and surgical surgical dissection.
2.1.6
Hooked hookblade
A part of the spine hook, placed under the bone structure, on or in order to achieve the connection.
2.1.7
Hook body hookbody
A part of the spine hook used to connect the hook and the longitudinal part.
2.1.8
Post post
Non-threaded anchors connected to the spine, pelvis or ribs through non-threaded holes.
2.1.9
Screw screw
An anchors connected to the spine, pelvis, or ribs by threading.
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