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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 0924.1-2014
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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 ---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.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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