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YY/T 0919-2014Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (English PDF)

无源外科植入物关节置换植入物膝关节置换植入物的专用要求

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 0919-2014 is the English-translated version of 无源外科植入物关节置换植入物膝关节置换植入物的专用要求.

YY/T 0919-2014 is the Chinese standard "Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants". Its scope clause reads: This standard specifies the knee replacement implant-specific requirements.

General safety, this standard specifies the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and manufacturers Information, as well as the requirements, test methods. Its clauses include terms and definitions.

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Document preview — YY/T 0919-2014

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C35

Issued by: National Medical Products Administration

Foreword
Introduction
1 Scope

1 Scope

This standard specifies the knee replacement implant-specific requirements.

General safety, this standard specifies the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and manufacturers

Information, as well as the requirements, test methods.

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.

YY/T 0640-2008 active surgical implants General requirements (ISO 14630.2005, IDT)

YY/T 0810.1 surgical implant a total knee prosthesis - Part 1. Fatigue properties of knee tibial tray Determination (YY/T 0810.1-2010, ISO 14879-1.2000, IDT)

YY/T 0924.1 Implants and total knee prosthetic components - Part 1. Classification, definitions and dimensions (YY/T 0924.1-2014, ISO 7207-1.2007, MOD)

ISO 14243-1 Implants for surgery - Wear of total knee prostheses - Part 1. load control load and wear tester position

Shift parameters and the corresponding environmental conditions for test (Implantsforsurgey-Wearoftotalknee-jointprostheses-Part 1.

Loadinganddisplacementparametersforwear-testingmachineswithloadcontrolandcorresponding enviromentconditionsfortest)

ISO 14243-2 Implants for surgery - Wear of total knee prostheses - Part 2. Methods of measurement (Implantsforsurgey-

Wearoftotalknee-jointprostheses-Part 2. Methodsofmeasurement)

ISO 14243-3 Implants for surgery - Wear of total knee prosthesis Part 3. displacement control load and wear tester position

Shift parameters and the corresponding environmental conditions for test (Implantsforsurgey-Wearoftotalknee-jointprostheses-Part 3.

Loadinganddisplacementparametersforwear-testingmachineswithdisplacementcontrolandcorre- spondingenvironmentalconditionsfortest)

ISO 21534.2007 active surgical implants - Joint replacement implants - Particular requirements (Non-activesurgery-Jointre- placementimplants-Particularrequirements)

3 Terms and Definitions

ISO 21534 and YY/T 0924.1 and the definition of the following definitions apply to this document.

3.1 Femoral component

For fixing on the femur and total knee replacement articular surface replacement parts.

NOTE. These implants may be manufactured in one piece or set of components assembled by the user.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 14630.2005 · ISO 14879 · ISO 7207 · ISO 14243

Cited by

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