YY/T 0809.6-2018 English PDF

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YY/T 0809.6-2018: Implants for surgery--Partial and total hip joint prostheses--Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
Status: Valid

YY/T 0809.6: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0809.6-2018	264	Add to Cart	3 days	Implants for surgery--Partial and total hip joint prostheses--Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components	Valid
YY/T 0809.6-2010	359	Add to Cart	3 days	[Replaced by YY/T 0809.6-2018] Implants for surgery. Partial and total hip joint prostheses. Part 6: Determination of endurance properties of head and neck region of stemmed femoral components	Obsolete

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YY/T 0809.10   YY/T 0809.12   YY/T 0809.2   YY/T 0809.13   YY/T 0809.4   YY/T 0809.1   

Basic data

Standard ID: YY/T 0809.6-2018 (YY/T0809.6-2018)
Description (Translated English): Implants for surgery--Partial and total hip joint prostheses--Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 14,197
Date of Issue: 2018-09-21
Date of Implementation: 2019-09-26
Older Standard (superseded by this standard): YY/T 0809.6-2010
Issuing agency(ies): State Drug Administration

YY/T 0809.6-2018: Implants for surgery--Partial and total hip joint prostheses--Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components

---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--Partial and total hip joint prostheses--Part 6. Endurance properties testing and performance requirements of neck region of stemmed femoral components ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0809.6-2010 Surgical implant part and total hip prosthesis Part 6. neck fatigue with shank femoral components Performance test and performance requirements Implantsforsurgery-Partialandtotalhipjointprostheses-Part 6. Endurance (ISO 7206-6.2013, IDT) 2018-09-21 released.2019-09-26 implementation State Drug Administration issued

Foreword

YY/T 0809 "Surgical Implant Part and Total Hip Prosthesis" is expected to be divided into the following sections. --- Part 1. Classification and dimensioning; --- Part 2. Metal, ceramic and plastic joint surfaces; --- Part 4. Fatigue performance test and performance requirements for shank femoral components; --- Part 6. neck fatigue performance test and performance requirements for shank femoral components; --- Part 8. Fatigue performance of shank femoral components with torque; --- Part 10. Determination of the antistatic force of the combined femoral head. This part is part 6 of YY/T 0809. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This section replaces YY/T 0809.6-2010 "Surgical Implant Part and Total Hip Prosthesis Part 6. Head with Mandible Femur And determination of neck fatigue performance. Compared with YY/T 0809.6-2010, the main technical changes except editorial changes are as follows. ---The standard name was modified from "Determination of fatigue performance of head and neck with shank femoral components" to "Neck fatigue performance of shank femoral components" Test and performance requirements", the standard has increased fatigue performance requirements; --- Adjusted the test parameters. This section uses the translation method equivalent to ISO 7206-6.2013 "Surgical Implant Part and Total Hip Prosthesis Part 6. Belt Neck fatigue performance test and performance requirements for shank femoral components. The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows. ---GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD); ---GB/T 25917-2010 axial force fatigue testing machine dynamic force calibration (ISO 4965. 1979, MOD); ---YY/T 0809.1-2010 Surgical implant part and total hip prosthesis Part 1. Classification and dimensioning (ISO 7206-1.2008, IDT). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This part is proposed by the State Drug Administration. This part is organized by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, orthopedic implants subcommittee (SAC/TC110/ SC1). This section drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai University, Chuangsheng Medical Devices (China) Co., Ltd., strong Health (Suzhou) Medical Equipment Co., Ltd. The main drafters of this section. Dong Shuangpeng, Zhang Zhenghui, Jiao Yongzhe, Hua Zikai, Chen Changsheng, Qiu Jianhong, Zhao Yuanyi, Chen Ruiqi. This section replaces YY/T 0809.6-2010. Surgical implant part and total hip prosthesis Part 6. neck fatigue with shank femoral components Performance test and performance requirements

1 Scope

This section of YY/T 0809 specifies neck fatigue of the femoral component with partial and total hip arthroplasty under specific test conditions. Test methods and performance requirements for performance. This section does not include studies on the performance of the femoral head or head and neck. This section applies to both combined and non-combined designs made of metal or non-metallic materials. This section also specifies the conditions of the test, considers the important parameters that affect the test femur components, and describes the method of installation of the specimen.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. ISO 3696.1987 Analytical laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specifica- Tionandtestmethods) ISO 4965 Metallic material uniaxial fatigue test dynamic force calibration (Metalicmaterials-Dynamicforcecalibration Foruniaxialfatiguetesting) ISO 7206-1 Surgical Implant Part and Total Hip Prosthesis Part 1. Classification and Dimensioning (Implantsforsur- gery-Partialandtotalhipjointprostheses-Part 1. Classification and designationofdimensions)

3 Terms and definitions

The following terms and definitions as defined by ISO 7206-1 apply to this document. 3.1 Implantable state The sample has been in the state of all machining, cleaning, degreasing and sterilization procedures required prior to implantation. 3.2 Osteotomy line/height resectionline/level According to the manufacturer, the proximal end osteotomy position of the femoral shaft corresponding to the femoral stem in clinical use.

4 Principle

The sample is embedded in the medium. For the combined femoral stem, the unembedded portion of the sample is submerged in the liquid medium. Applying to the head of the sample Add cyclic load until any of the conditions described in 8.10 occur.

5 materials

5.1 Embedding medium. A casting medium, which should. ......

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