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YY/T 0965-2014

Chinese Standard: 'YY/T 0965-2014'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0965-2014English419 Add to Cart Days<=4 Implants for surgery. Artificial ligaments Valid YY/T 0965-2014
YY/T 0965-2014Chinese24 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

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Detail Information of YY/T 0965-2014; YY/T0965-2014
Description (Translated English): Medical & Medicine
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.40
Word Count Estimation: 21,241
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: GB/T 16886.1-2011; GB/T 16886.17-2005; YY/T 0640-2008; ISO 14155-2011
Drafting Organization: Chinese Institute of Food and Drug test
Administrative Organization: National Surgical implants and orthopedic instruments Standardization 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 the clinical use of artificial ligaments textile implants (or ligament implants, ligament implants). This Standard specifies the technical requirements and test methods for textile artificial ligaments. Expected performance of the


YY/T 0965-2014
Implants for surgery. Artificial ligaments
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Active surgical implants of artificial ligament special requirements
Issued on: 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 3 Expected Performance
5 3 Design Properties
6 material 3
7 Design Evaluation 3
Clinical evaluation before 8 3
Test Method 5 9
10 Clinical Evaluation 6
After the market surveillance 6 11
12 Manufacturing 6
13 Sterilization 6
14 6 Packaging
Appendix A (normative) Dimensional inspection 7
(Normative) Appendix B testing mechanical properties 8
Annex C (normative) Fatigue Test --- wear strength and torsional strength test 12
Annex D (informative) wear test fixture 17
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized.
This standard was drafted: Chinese Academy of Food and Drug test.
The main drafters of this standard: Feng Xiaoming, Fubu Fang, Wang Jian, Zhang Na, Wang Chunren.
Active surgical implants of artificial ligament special requirements
1 Scope
This standard provides for clinical use textile artificial ligament implants (or ligament implants, ligament implants, hereinafter referred to as the implant
Material) of special requirements.
This standard specifies the technical requirements and test methods for textile artificial ligaments. The expected product performance, design attributes, materials, design Comment
Price, manufacture, sterilization, packaging and information supplied by the manufacturer, and so do the specific instructions.
This standard does not apply to non-woven artificial ligament, artificial ligaments but test methods may be appropriate for these types of reference of this standard.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation of the risk management process and Test
GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17: leachables allows the establishment of a limited amount of
YY/T 0640-2008 active surgical implants General requirements
People's Republic of China Pharmacopoeia (2010 edition)
ISO 14155 (all parts) Medical Device Clinical Investigation (Clinicalinvestigationofmedicaldevicesforhuman-
subjects)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Artificial ligament artificialligaments
Force between the implant wholly or partially transfer the soft tissue and soft tissue, soft tissue and hard tissue, hard tissue and hard tissue.
Artificial ligament also includes a natural-like structure supporting ligaments; and use the natural structure of the ligament prosthesis. Support for ligament should be
On behalf of nearly ligament strength and keep this intensity in a given period. And whether an increase in transplantation (autologous) tissue case
They can be used.
3.2
Semi-finished semi-finishedproducts
Production of the basic components of artificial ligaments (cords, straps, braids, etc.).
3.3
Fatigue wear test equipment fatigueweartestequipment
Fatigue tests on the device with active components, test relative to a fixed member alternately pulling straight line, so that the specimen in the solid
Given by the friction surface rubs.
3.4
Fatigue torsion test equipment fatiguereversetestequipment
With activities on the fatigue test equipment components, test components with respect to a fixed alternating motion by applying the ligament
Related standard:   YY/T 0962-2014  YY 0465-2019
   
 
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