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YY/T 0924.1-2014 English PDF

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YY/T 0924.1-2014: Implants for surgery. Components for partial and total knee joint prostheses. Part 1: Classification, definitions and designation of dimensions
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YY/T 0924.1-2014English369 Add to Cart 3 days [Need to translate] Implants for surgery. Components for partial and total knee joint prostheses. Part 1: Classification, definitions and designation of dimensions Valid YY/T 0924.1-2014

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Standard similar to YY/T 0924.1-2014

YY/T 0962   YY/T 0987.1   YY/T 0987.2   YY/T 0924.2   YY/T 0917   YY/T 0919   

Basic data

Standard ID YY/T 0924.1-2014 (YY/T0924.1-2014)
Description (Translated English) Implants for surgery. Components for partial and total knee joint prostheses. Part 1: Classification, definitions and designation of dimensions
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 16,112
Date of Issue 6/17/2014
Date of Implementation 7/1/2015
Quoted Standard GB/T 12417.2; YY/T 0919
Adopted Standard ISO 7207-1-2007, MOD
Regulation (derived from) China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies) State Food and Drug Administration
Summary This Standard applies to partial and total knee prosthesis components. This Standard specifies the femur of one or more compartments of the knee of the supporting surface of the knee joint replacement prosthesis, the tibia and patella component classifica

YY/T 0924.1-2014: Implants for surgery. Components for partial and total knee joint prostheses. Part 1: Classification, definitions and designation of dimensions


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Implants for surgery.Components for partial and total knee joint prostheses.Part 1. Classification, definitions and designation of dimensions ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Implants and the total knee prosthesis member Part 1. Classification, definitions and dimensions Part 1. Classification, definitionsanddesignationofdimensions (ISO 7207-1.2007, MOD) Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

YY/T 0924 "Implants and total knee prosthetic component" is divided into two parts. --- Part 1. Classification, definitions and dimensions; --- Part 2. metal, ceramic and plastic joint surfaces. This section YY/T Section 10924 of. This section drafted in accordance with GB/T 1.1-2009 given rules. This section uses the translation method to modify using 7207-1 ISO .2007 Part 1 Implants and total knee prosthetic component " Score. Classification, definitions and dimensions. " This part of ISO 7207-1. Compared to 2007, the only normative references have been adjusted to technical differences, in order to adapt to China Technical conditions, the consistency of the correspondence section of the international normative documents referenced in our country with the following documents. GB/T 12417.2-2008 active surgical implants bone and joint replacement implants - Part 2. joint replacement implants Particular requirements (ISO 21534.2002) YY/T 0919-2014 "active surgical implants - Joint replacement implants - Particular requirements for knee joint replacement implants" (ISO 21536.2007) 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 part is proposed by the China Food and Drug Administration. This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC / TC110/SC1) centralized. This section is drafted. Tianjin State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, the State Food and Drug Pipe Authority for Medical Device Evaluation Center. The main drafters of this section. Li Libin, Jiaoyong Zhe, Li Nan Song Duo, Shi Xinli, Liu Bin, Liu Yinghui, Guo Xiaolei. Implants and the total knee prosthesis member Part 1. Classification, definitions and dimensions

1 Scope

YY/T 0924 this part of the femur to one or more compartments of the knee of the supporting surface replacement knee prosthesis, tibia and patella component It was classified, and gives the definition of components and dimensions.

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 12417.2 active surgical implants bone and joint replacement implants - Part 2. Particular requirements for joint replacement implants Demand (GB/T 12417.2-2008, ISO 21534.2002, IDT) YY/T 0919 active surgical implants - Joint replacement implants - Particular requirements for knee joint replacement implants (YY/T 0919- 2014, ISO 21536.2007, MOD)

3 Terms and Definitions

GB/T 12417.2 and YY/T 0919 defined by the following terms and definitions apply to this document. 3.1 Types of knee prosthesis 3.1.1 Total knee prosthesis totalkneejointprosthesis Double-room rooms three or knee prosthesis. Note. double-room total knee prosthesis in Figure 1. Room three total knee prosthesis Figure 7c). 3.1.2 Single compartment knee prosthesis uni-compartmentalkneejointprosthesis An implant component for femoral and tibial articular surface replacement knee medial or lateral compartments. Note. Single-compartment knee prosthesis shown in Figure 2. 3.1.3 Double-room knee prosthesis bi-compartmentalkneejointprosthesis An implant means for substituting the knee medial and lateral compartments of the articular surface of the femur and tibia. Note. double-room knee prosthesis shown in Figure 3 to 5. 3.1.4 Room three knee prosthesis tri-compartmentalkneejointprosthesis An implant component for femoral and tibial articular surface replacement knee medial and lateral compartments, and a patella - femoral compartment Patella and femoral articular surface. Note. Room three knee prosthesis Figure 7c).

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