YY/T 0651.1-2016 English PDF

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YY/T 0651.1-2016: Implants for surgery. Wear of total hip-joint prostheses. Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
Status: Valid

YY/T 0651.1: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0651.1-2016	204	Add to Cart	3 days	Implants for surgery. Wear of total hip-joint prostheses. Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test	Valid
YY/T 0651.1-2008	319	Add to Cart	3 days	Implant for surgery. Wear of total hip-joint prostheses. Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test	Obsolete

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YY/T 0647   YY/T 0752   YY/T 0695   YY/T 0663.2   YY/T 0651.3   YY/T 0651.2   

Basic data

Standard ID: YY/T 0651.1-2016 (YY/T0651.1-2016)
Description (Translated English): Implants for surgery. Wear of total hip-joint prostheses. Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 11,194
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Older Standard (superseded by this standard): YY/T 0651.1-2008
Quoted Standard: ISO 3696; ISO 7206-1; ISO 14242-2
Adopted Standard: ISO 14242-1-2012, IDT
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 relative angular motion, test loading mode, test speed and duration, specimen assembly, and test environment requirements for joint parts during total hip arthroplasty.

YY/T 0651.1-2016: Implants for surgery. Wear of total hip-joint prostheses. Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

---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.
Implants for surgery.Wear of total hip-joint prostheses.Part 1. Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0651.1-2008 Peripheral prosthesis of surgical implants Part 1. load and displacement of wear testing machines Parameters and associated test environmental conditions Part 1. Loadinganddisplacementparametersforwear-testingmachinesand (ISO 14242-1..2012, IDT) 2016-01-26 Release.2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 Principle 1 5 test samples, control samples and test medium 2 Equipment and equipment 7 Test procedure 6 8 Test Report 7 9 Sample Handling 7 Appendix A (informative) Calculation formula for obtaining the rotation and load curve

Foreword

YY/T 0651 "Surgical implants for total hip prosthesis wear" is divided into the following three parts. - Part 1. Load and displacement parameters for wear testing machines and associated test environmental conditions; - Part 2. Methods of measurement; Part 3. Load and displacement parameters for track bearing wear testing machines and associated test environmental conditions. This part is part 1 of YY/T 0651. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part uses the translation method equivalent to ISO 14242-1..2012 "Surgical implants for total hip prosthesis wear Part 1. hip Joint load test machine load and displacement parameters and related test environmental conditions ". Appendix A lists the parameters for obtaining the rotation and load curves Formula. This part replaces YY/T 0651.1-2008 "Surgical implants for total hip prosthesis wear Part 1. Hip wear test Machine load and displacement parameters and related test environmental conditions ", compared with YY/T 0651.1-2008, in addition to editorial modification of the main technology The changes are as follows. --- YY/T 0651.1-2008 only includes internal rotation/external rotation movement, this standard includes three kinds of movement, namely the internal rotation/external rotation movement, adduction / Outreach and flexion/stretching; --- YY/T 0651.1-2008 in the test medium in the protein concentration of not less than 17g/L, the standard provisions of the test medium Of the protein concentration of 30g/L ± 2g/L; --- YY/T 0651.1-2008 does not include the contents of the temperature control system, without considering the impact of temperature on the wear and tear, this standard Including the contents of the temperature control system; --- YY/T 0651.1-2008 does not include the contents of the loading and motion curves. This standard includes the loading and motion curves of the test. In this part of the normative reference to the international documents have a consistent correspondence between the following documents. Analysis of laboratory water specifications and test methods (ISO 3696. 1987, MOD); GB/T 6682-2008; Surgical implants and full hip prostheses - Part 1. Classification and dimensioning - YY/T 0809.1-2010 (ISO 7206-1..2008, IDT); - YY/T 0651.2-2008 Surgical implants for wearing all hip prostheses Part 2. Methods of measurement (ISO 14242- 2..2000, IDT). 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 organized by the National Committee for the Standardization of Surgical Implants and Orthopedic Instruments Orthopedic Implants Subcommittee (SAC/TC110 / SC1). This part of the drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center, China Food and Drug Research Institute, China University of Mining and Technology, West An Jiaotong University. This part of the main drafters. Dong Shuangpeng, Jiao Yongzhe, Wang Shuo, Wang Ying, Liu Li, Tang Jinglong, Ge Shirong, Wang Qingliang, Wang Ling, Peng Xifeng. This part of the replacement of the previous version of the standard release. --- YY/T 0651.1-2008. Peripheral prosthesis of surgical implants Part 1. load and displacement of wear testing machines Parameters and associated test environmental conditions

1 Scope

This part of YY/T 0651 specifies the relative angular motion of the joint parts during the total hip prosthesis wear test, the test loading mode, Test speed and duration, sample assembly, and test environment requirements.

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. ISO 3696 Analytical laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specification andtestmethods) ISO 7206-1 Surgical Implants Part and Total Hip Joints Part 1. Classification and Dimensioning (Implantsforsur- gery-Partialandtotalhip-jointprostheses-Part 1. Classificationanddesignationofdimensions) ISO 14242-2 Peripheral prosthesis implantation of surgical implants - Part 2. Methods of measurement (Implantsforsurgery- Wearoftotalhip-jointprostheses-Part 2. Methodsofmeasurement)

3 terms and definitions

ISO 7206-1 and the following terms and definitions apply to this document. 3.1 Outreach/adduction As shown in Figure 1a). 3.2 Flexion/extension flexion/extension As shown in Figure 1b). 3.3 Inside/outside rotation inward/outwardrotation As shown in Figure 1c). 3.4 Polar axis The axis of the acetabular component, through the spherical surface of the spherical articular surface, is perpendicular to the plane of the acetabular flange or the inlet diameter (without the flange).

4 principle

The femoral component and acetabular component of the test sample were assembled in the intended combination. Through the test device to make between the two at any time ......

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