YY/T 1502-2016 English PDF

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YY/T 1502-2016: Spinal implants--Intervertebral body fusion devices
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1502-2016	159	Add to Cart	3 days	Spinal implants--Intervertebral body fusion devices	Valid

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Basic data

Standard ID: YY/T 1502-2016 (YY/T1502-2016)
Description (Translated English): Spinal implants--Intervertebral body fusion devices
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Word Count Estimation: 8,832
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Quoted Standard: GB/T 4340.1; GB/T 10610; GB/T 13810; GB/T 16886.5; GB 23102; YY/T 0343; YY/T 0586; YY/T 0640-2008; YY/T 0959; YY/T 0960; YY/T 0966; YY/T 0660
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the terms and definitions of intervertebral fusion, expected performance, design attributes, materials, preclinical evaluation, manufacture, sterilization, packaging and information provided by the manufacturer. This standard applies to intervertebral fusion devices that are placed in the intervertebral disc position and provide support for the fusion of the two vertebral bodies. This standard is applicable to interbody fusion devices made of metal and polymeric materials and is not suitable for use in combination products (eg intervertebral fusion devices using bone morphological proteins).

YY/T 1502-2016: Spinal implants--Intervertebral body fusion devices

---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 - Intervertebral body fusion devices ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Spine implants intervertebral fusion 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency does not assume responsibility for identifying 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 standard drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center, a medical device China (limited) company. The main drafters of this standard. Ma Jinzhu, Zhao Binghui, Meng Tao, Cai Yong, Chen Changsheng. Spine implants intervertebral fusion

1 Scope

This standard specifies the terms and definitions of intervertebral fusion, expected performance, design attributes, materials, preclinical evaluation, manufacturing, sterilization, packaging And the information provided by the manufacturer. This standard is applicable to intervertebral fusion devices that are placed in the intervertebral disc position and provide support for the fusion of the two vertebral bodies. This standard applies to intermolecular fusion devices made of metal and polymeric materials and is not suitable for use in pharmaceutical combinations (eg, White interbody fusion cage).

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. Metallic materials - Vickers hardness test - Part 1. Test methods GB/T GB/T 10610 Geometrical product specifications (GPS) - Surface texture contour method - Rules and methods for assessing surface structures GB/T 13810 Surgical implants for titanium and titanium alloys Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test GB/T 16886.5 GB 23102 surgical implants metal materials Ti-6Al-7Nb alloy processing materials YY/T 0343 Surgical metal implants - Liquid penetration test Test method for X - ray impermeability of medical polymer products YY/T 0586 General requirements for passive surgical implants YY/T 0640-2008 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implants YY/T 0660 Test Method for Mechanical Properties of Lumbar Implant Interbody Fusion Instrument YY/T 0959 Standard Test Method for Static Axial Compressive Subsidence of Lumbar Implant Interbody Fusion Instrument YY/T 0960 YY/T 0966 Surgical Implants Metal Materials Pure Tantalum

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Interbody fusion intervertebralbody A (biological or artificial) instrument that is mounted on the intervertebral disc between two segments of the intervertebral body. The purpose is for the end of two adjacent vertebral bodies Integration to provide support. [YY/T 0959-2014, definition 3.7] 3.2 Vertebral sinking intervertebralsubsidence Has been implanted in the intervertebral fusion device around the vertebral body defect or subsidence process, the process will lead to disc height loss. [YY/T 0960-2014, definition 3.5] ......

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