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

外科植入物部分和全膝关节假体股骨和胫骨部件第1部分：分类、定义和尺寸标注

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 0924.1-2014 is the English-translated version of 外科植入物部分和全膝关节假体股骨和胫骨部件第1部分：分类、定义和尺寸标注.

YY/T 0924.1-2014 is the Chinese pharmaceutical industry standard that classifies the components of partial and total knee joint prostheses, the femoral, tibial and patellar components that replace the bearing surfaces of one or more compartments of the knee, and gives their definitions and the designation of their dimensions.

It is the first part of the YY/T 0924 series and provides the vocabulary and the dimensional conventions on which the other parts of the series rest. Issued on 17 June 2014, it has applied since 1 July 2015.

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Document preview — YY/T 0924.1-2014

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 35

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and Definitions

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)

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

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

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

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

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).

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

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