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YY/T 0119.1-2014

Search Result of Chinese Standard: 'YY/T 0119.1-2014'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0119.1-2014English299 Add to Cart Days<=3 Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 1: General requirements Valid YY/T 0119.1-2014
YY/T 0119.1-2014Chinese18 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   
Detail Information of YY/T 0119.1-2014; YY/T0119.1-2014
Description (Translated English): Medical & Medicine
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 15,188
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Older Standard (superseded by this standard): YY 0119-2002; YY 0120-2002
Quoted Standard: GB 4234; GB/T 10623; GB/T 13810; GB/T 16825.1; GB 23102; YY/T 0119.2-2014; YY/T 0119.3-2014; YY/T 0119.4-2104; YY/T 0640-2008; YY/T 0857; YY/T 0961; ISO 5832-2; ISO 5832-3; ASTM F382; ASTM F543; ASTM F1582
Adopted Standard: ASTM F2193-2007, IDT
Drafting Organization: Tianjin Medical Devices Inspection Center
Administrative Organization: National Surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Sub-Technical Committee
Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30
Proposing organization: State Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard applies to individual components within the spinal fixation system in use. This Standard specifies to describe the materials, manufacturing, sterilization, packaging and manufacturer generic term spinal fixation system component dimensions a


YY/T 0119.1-2014
Spinal implants.Components used in the surgical fixation of the spinal skeletal system.Part 1. General requirements
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Part of the replacement YY 0119-2002, YY 0120-2002
Spinal implant fixation
System components - Part 1. General requirements
Spinalimplants-Componentsusedinthesurgicalfixationofthespinal
skeletalsystem-Part 1. Generalrequirements
Released on.2014-06-17
2015-07-01 implementation
State Food and Drug Administration issued
Directory
Preface I
Introduction II
1 range 1
2 normative reference document 1
3 Terms and definitions 1
4 meaning and application 5
Material 6
6 Requirements 6
7 manufacturing 6
8 sterilization 6
9 Packing 6
10 Information provided by the manufacturer 6
Appendix A (informative) Basic principles 8
Appendix B (informative) List of Approved Methods for Chemical Analysis
Reference 10
Preface
YY/T 0119 "Spinal implants internal fixation system components" is divided into five parts.
- Part 1. General requirements;
- Part 2. metal spine screws;
- Part 3. metal spine plate;
- Part 4. metal spine rods;
Part 5. Test methods for the determination of static and fatigue bending strength of metallic spine screws.
This part is part 1 of YY/T 0119.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section uses the re-drafting method for reference to ASTM F2193-07 "Standard Requirements and Test Methods for Spinal Internal Fixation System Components"
Text and Appendix X1.
YY/T 0119-2014 "Spinal Implant Spinal Fixation System Components" with YY 0119-2002 "Bone Implanted Implant Metal
Orthodontic nail ", YY 0120-2002" bone joint implant metal orthopedic bar "the main difference.
--- YY 0119-2002, YY 0120-2002 in the material, including stainless steel, titanium alloy, and YY/T 0119-2014 also package
Including pure titanium, so YY/T 0119-2014 a wider range of applications;
--- YY/T 0119-2014 added to the metal spine screw, metal spine plate and metal spine rods related performance test.
This part from the date of implementation, instead of YY 0119-2002 "bone joint implant metal orthopedic nail" in the pedicle screw, vertebral
Body nail and sacral nail content and YY 0120-2002 "bone joint implant metal orthopedic stick". Enterprises can refer to this part and reference
YY 0341-2009 "Common technical conditions for passive surgical metal implants for bone grafting".
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 section is proposed by the State Food and Drug Administration.
This section is composed of the National Committee for the Standardization of Surgical Implants and Orthopedic Instruments, the Subcommittee on Materials and Orthopedic Implants (SAC /
TC110/SC1).
This part of the drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai minimally invasive orthopedic Medical Technology Co., Ltd., Medtronic (on
Sea) management limited company.
This part of the main drafters. Jiang Xi, Zhang Chen, Dong Shuangpeng, Li Libin, Qu Xiaobin, Wang Guohui, Ma Yunpeng.
introduction
This standard is intended to provide a comprehensive technical reference for components in the spinal fixation system, which specifies the material, properties,
Manufacture, sterilization, packaging and information provided by the manufacturer. This section specifies the passages used to describe the size of the spine and other physical characteristics
In terms of terminology, and defines a performance definition related to the function of the spinal implant component. The four parts of the standard follow the different spine parts
Performance requirements and standard test methods for the performance of spinal components and performance-related mechanical characteristics of a unified test.
This section is not intended to define the performance level of a spinal component or the clinical performance of a particular case. Currently do not have enough knowledge to advance
The impact of the application of these components on specific activities in the individual's daily life. In addition, this part is not intended to describe or regulate
The specific design type of individual components in the internal fixation system.
This section may not apply to all types of spinal fixation systems. Users should be cautious according to the specific implant system and its intended application
Consider the applicability of this section.
This section applies to individual components used in the spinal fixation system. If the user on the spine fixation system evaluation system higher
Horizontal - the interconnection between individual components and components (two or more parts) is of interest, refer to YY/T 0961-2014.
The highest level of the evaluation system for the spine fixation system can be found in YY/T 0857-2011, which is used to evaluate the assembly of multiple components
Into a complete system that involves many components and their interconnection.
When evaluating materials in accordance with the requirements of this section, hazardous materials, operations and equipment may be involved. This section is not intended to be right
All of the security issues involved are described, even those related to their use of security issues. Establish appropriate safety and use before use
Hygienic practices, and the applicability of clear regulatory restrictions are the responsibility of this part of the user.
Spinal implant fixation
System components - Part 1. General requirements
1 Scope
This part of YY/T 0119 specifies general terms used to describe the dimensions and other physical characteristics of the internal fixation system of the spine,
The material, manufacture, sterilization, packaging and information provided by the manufacturer of the internal fixation system of the spine are required.
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.
GB 4234 Stainless steel for surgical implants
Test terminology for mechanical properties of metallic materials GB/T
GB/T 13810 Surgical implants for titanium and titanium alloys
GB/T 16825.1 Tests for static uniaxial testing machines - Part 1. Tests for force measurement systems of tension and/or pressure testing machines
calibration
GB 23102 surgical implants metal materials Ti-6Al-7Nb alloy processing materials
YY/T 0119.2-2014 Spinal implants Spinal internal fixation system components - Part 2. Metal spine screws
YY/T 0119.3-2014 Spinal implants Spinal internal fixation system components - Part 3. Metal spine plates
YY/T 0119.4-2014 Spinal implants Spinal internal fixation system components - Part 4. Metal spine rods
General requirements for passive surgical implants YY/T 0640-2008
Test method for spinal implant in vertebral resection model YY/T 0857
YY/T 0961 Static and Fatigue Performance Evaluation Methods for Spine Implant Assembly and Connecting Devices
ISO 5832-2 Surgical implants - Metallic materials - Part 2. Implantsforsurgery - Metalicmaterials -
Part 2. Unaloyedtitanium)
ISO 5832-3 Surgical implants - Metallic materials - Part 3. Forged titanium - 6 - 4 - vanadium alloys (Implantsforsurgery -
Metalicmaterials-Part 3. Wroughttitanium6-aluminium-vanadiumaloy)
Standard requirements and test methods for ASTMF382 metal plate (Specification and MethodMetalic
BonePlates)
Standard Requirements and Test Methods for ASTM F543 Medical Metallic Bone Screws (Specification andTestMethodsfor
MetalicMedicalBoneScrews)
ASTM F1582 and spinal implant-related terms (TerminologyRelatingtoSpinalImplants)
3 terms and definitions
GB/T 10623, YY/T 0857, YY/T 0961, ASTM F382, ASTM F543, ASTM F1582, and
The terms and definitions apply to this document.
Related standard:   YY/T 0119.2-2014  YY/T 0119.3-2014
   
 
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