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YY/T 0924.2-2024: Joint replacements - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials
Status: Valid YY/T 0924.2: Evolution and historical versions
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| YY/T 0924.2-2024 | English | 209 |
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Joint replacements - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials
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YY/T 0924.2-2024
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| YY/T 0924.2-2014 | English | 94 |
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Implants for surgery. Copponents for partial and total knee joint prostheses. Part 2: Articulating surfaces made of metal, ceramic and plastics materials
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YY/T 0924.2-2014
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Basic data | Standard ID | YY/T 0924.2-2024 (YY/T0924.2-2024) | | Description (Translated English) | Joint replacements - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,187 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Older Standard (superseded by this standard) | YY/T 0924.2-2014 | | Issuing agency(ies) | State Drug Administration | YY/T 0924.2-2024: Joint replacements - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials
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ICS 11.040.40
CCSC35
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0924.2-2014
Joint replacement implants and total knee prostheses
Components - Part 2.Metal, ceramic and plastic joint surfaces
(ISO 7207-2.2011 AMD1.2016 AMD2.2020, Implantsforsurgery-
Published on July 8, 2024, implemented on July 20, 2025
The State Drug Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Surface roughness requirements 1
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting is required.
This document is Part 2 of YY/T 0924 “Implantable Devices for Joint Replacement and Components of Total Knee Prosthesis”.
The following parts have been published.
--- Part 1.Classification, definition and dimensioning;
--- Part 2.Metal, ceramic and plastic joint surfaces.
This document replaces YY/T 0924.2-2014 "Surgical implant parts and total knee prosthesis components Part 2.Metal, ceramic
Compared with YY/T 0924.2-2014, the main technical changes are as follows.
--- Incorporated the amendments to ISO 7207-2.2011 AMD1.2016 AMD2.2020, the outer margins of the clauses involved
Blank locations are marked with double vertical lines (‖).
● Added reference to YY/T 0924.1 (see Chapter 2).
● The surface roughness requirements have been changed (see 4.2,.2014 edition 3.2).
This document is modified to adopt ISO 7207-2.2011 AMD1.2016 AMD2.2020 “Partial and total knee implants for surgery”
Prosthetic components Part 2.Metal, ceramic and plastic articular surfaces.
A new chapter “Terms and Definitions” has been added to this document.
The technical differences between this document and ISO 7207-2.2011 AMD1.2016 AMD2.2020 and their reasons are as follows.
--- Regarding normative references, this document has been adjusted with technical differences to adapt to my country's technical conditions.
The situation is reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replaced ISO 4287 with GB/T 3505 which is equivalent to the international standard;
● Replaced ISO 4288 with GB/T 10610 which is equivalent to the international standard;
● ISO 7207-1 was replaced by YY/T 0924.1 which is modified to adopt the international standard.
The following editorial changes were made to this document.
--- Changed the name of the standard, using "joint replacement implants" instead of "surgical implants" to clarify the specific application areas of the standard.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document was prepared by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, Orthopedic Implants Subcommittee (SAC/
TC110/SC1) is responsible for this.
This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, National Medical Products Administration Medical Device Technical Review Center
Center, National Medical Products Administration Medical Device Technical Review and Inspection Greater Bay Area Center, Dabao Medical Technology Co., Ltd., Suzhou Microport
ARTICULAR MEDICAL TECHNOLOGY LIMITED.
The main drafters of this document are. Li Nan, Li Wenjiao, Dong Shuangpeng, Wang Ying, Min Yue, Sun Jiayi, Zhang Kun, Lu Minqi, Zeng Da, and Yu Tianbai.
This document was first published in.2014 and this is the first revision.
Introduction
YY/T 0924 "Joint replacement implant components and total knee prosthesis components" is intended to consist of two parts.
--- Part 1.Classification, definitions and dimensioning. The purpose is to give the knee joint bearing surface replacement of one or more compartments of the knee
Classification of the femoral, tibial, and patellar components of the prosthesis and definition and dimensioning of the components.
--- Part 2.Metal, ceramic and plastic joint surfaces. The purpose is to give partial and total knee joints classified according to YY/T 0924.1.
Requirements for the surface roughness of the articular surface of joint prostheses.
The purpose of this document is to provide guidance on the periodic validation of production processes.
Joint replacement implants and total knee prostheses
Components - Part 2.Metal, ceramic and plastic joint surfaces
1 Scope
This document specifies the requirements for the surface roughness of the articular surfaces of partial and total knee prostheses classified as in YY/T 0924.1.
This document is applicable to the evaluation of the surface roughness of metal, ceramic and plastic joint surfaces of joint replacement implant devices and total knee prosthesis components.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 3505 Product Geometry Specification (GPS) Surface Structure Profile Method Terminology, Definitions and Surface Structure Parameters
(GB/T 3505-2009, ISO 4287.1997, IDT)
GB/T 10610 Geometric Product Specification (GPS) Rules and methods for evaluating surface structure by surface structure profile method
(GB/T 10610-2009, ISO 4288.1996, IDT)
YY/T 0924.1 Surgical implant parts and total knee prosthesis components Part 1.Classification, definition and dimensioning
(YY/T 0924.1-2014,ISO 7207-1.2007, MOD)
3 Terms and definitions
There are no terms or definitions that require definition in this document.
4 Surface roughness requirements
4.1 General
The measurement of the surface roughness of knee prosthesis components shall follow the principles given in GB/T 3505 and the
rules and procedures.
4.2 Knee prosthesis
4.2.1 Metal or ceramic femoral components
When measuring in accordance with GB/T 10610, the measurement points of all articular surfaces of metal or ceramic femoral components should be distributed at characteristic positions.
The surface roughness Ramax of the component should not be greater than 0.1μm, and the sampling length is 0.25mm.
When analyzing a bicompartmental or tricompartmental knee prosthesis, the lateral and medial femoral condyles should be measured at the following locations.
a) Contact position with articular surface flexed at 0°;
b) contact position with the articular surface bent at 30°;
c) Contact position with the articular surface flexed 60° or more.
When analyzing a three-compartment knee prosthesis, measurements should be taken at three evenly spaced locations on the femoral component where it contacts the patella.
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