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YY 0502-2016Joint replacement implants—Knee joint prostheses (English PDF)

关节置换植入物膝关节假体

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

January 26, 2016

Implementation date

January 1, 2018

Scope

YY 0502-2016 is the English-translated version of 关节置换植入物膝关节假体.

YY 0502-2016 is the Chinese standard "Joint Replacement Implants - Knee Joint Prostheses".

Its scope clause reads: This Standard specifies the requirements for terms and definitions, classification and dimension marking, expected performance, design attributes, materials, design evaluation, manufacture, sterilization, package, and information provided by the manufacturer of the knee joint prostheses.

This Standard is applicable to partial or total knee joint prostheses manufactured by the materials and processes specified in this Standard.

Its clauses include terms and definitions; classification and dimension marking; expected performance; design attributes; materials; design evaluation; manufacture; sterilization; package; information provided by the manufacturer.

It was issued by the China Food and Drug Administration on JANUARY 26, 2016 and took effect on JANUARY 01, 2018.

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Document preview — YY 0502-2016

National Standard of the People's Republic of China

Replacing: YY 0502-2005

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

Foreword3
1 Scope4
2 Normative References4
3 Terms and Definitions7
4 Classification and Dimension Marking7
5 Expected Performance7
6 Design Attributes7
7 Materials7
8 Design Evaluation10
9 Manufacture12
10 Sterilization12
11 Package13
12 Information Provided by the Manufacturer13
Appendix A (Normative) Approved Material Standard List on Manufacturing the Knee Joint Prostheses14
Appendix B (Normative) Approved and Non-Approved Material List on Manufacturing Articular Surface of Knee Joint Prostheses16
Appendix C (Normative) Approved and Non-Approved Metal Combination List on Non-Articular Contact Surface of Knee Joint Prostheses18
Appendix D (Normative) Approved Standard List for Chemical Analysis Method19

Foreword

The Sub-clause 8.6.3 in this Standard is recommended, while the rest are mandatory.

This Standard was drafted as per the rules specified in GB/T 1.1-2009.

This Standard replaced YY 0502-2005 Knee Joint Prostheses; compared with YY 0502-2005, this Standard has the major technical differences as follows.

--- Add evaluation of oxidation stability and morphology of UHMWPE materials (see 7.3.1 of this Edition);

--- Add requirements for extensively radiation-cross-linked UHMWPE (see 7.3.2 of this Edition);

--- Add plasma sprayed metal coating (see 7.5.2 of this Edition);

--- Modify the applicable scope of the surface defects (see 8.3 of this Edition; 6.2.2 of Edition 2005);

--- Modify the minimum thickness of UHMWPE component without tibial tray (see 8.5.2 of this Edition; 6.2.4.2 of Edition 2005);

--- Add dynamic mechanical properties (see 8.6 of this Edition);

--- Add requirements for relative angular motion range (see 8.7 of this Edition);

--- Delete inspection rules (see Clause 8 of Edition 2005).

Please note some contents of this document may involve the patents. The issuing agency of this document doesn't assume the responsibility to identify these patents.

1 Scope

This Standard specifies the requirements for terms and definitions, classification and dimension marking, expected performance, design attributes, materials, design evaluation, manufacture, sterilization, package, and information provided by the manufacturer of the knee joint prostheses.

This Standard is applicable to partial or total knee joint prostheses manufactured by the materials and processes specified in this Standard.

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document.

GB/T 10610 Geometrical Product Specifications(GPS) - Surface Texture - Profile Method - Rules and Procedures for the Assessment of Surface Texture

GB/T 14233.1 Test Methods for Infusion Transfusion Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods

GB/T 14233.2 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use-Part 2: Biological Test Methods

GB/T 16886.7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals

GB 18278 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization

3 Terms and Definitions

The following terms and definitions and those ones stipulated in YY/T 0919, YY/T 0924.1 and ISO 21534 are applicable to this document.

3.1 Conventional UHMWPE

The UHMWPE manufactured by mold pressing or extrusion molding, without cross-linked treatment prior to the final sterilization.

4 Classification and Dimension Marking

4.1 Classification

It shall meet the requirements of YY/T 0924.1.

5 Expected Performance

It shall meet the requirements of YY/T 0919.

6 Design Attributes

It shall meet the requirements of YY/T 0919.

7 Materials

7.2 Metallic materials.

7.1 General

The requirements in YY/T 0919 and the following contents are applicable to this Standard.

7.3 UHMWPE material

7.3.1 The physical properties of conventional UHMWPE material used for manufacturing the knee joint prostheses shall conform to the provisions of GB/T 19701.2; the content of impurity elements shall conform to the provisions of GB/T19701.1.

7.3.2 The manufacturer shall specify the performance index of extensively radiation-cross-linked UHMWPE material according to the requirements of YY/T 0811.

7.4 Ceramic material

The physical and chemical properties of ceramic material used for manufacturing knee joint prostheses shall conform to the provisions of ISO 6474-1, ISO 6474-2 or ISO 13356.

7.5 Coating material

7.5.2.3 Mechanical properties

7.5.2.3.1 Perform the shear fatigue test of coatings as per the test method in ASTM F1160; the test at specified shear fatigue strength shall at least finish 107 times cycles.

7.5.2.3.2 When testing as per the test method given in ASTM F1044, the shear strength between coating and matrix shall reach 20MPa above.

7.5.2.3.3 When testing as per the test method given in ASTM F1147, the tensile strength between coating and matrix shall reach 22MPa above.

8 Design Evaluation

8.1 General

The requirements of YY/T 0919 and the following contents are applicable to this Standard.

8.2 Appearance

8.2.3 Ceramic surface

When visually examining with normal or corrected vision, the articular surface of the ceramic parts of knee joint prostheses shall be free of particulate contamination, spot-like or larger chemical color change, knife marks, small gaps, debris, depressions, cracks and the like defects.

8.3 Surface defects

When testing as per the test method given in YY/T 0343, the surface of the uncoated metal parts and the surface of ceramic parts shall be free of discontinuous defects.

8.4 Surface roughness

8.4.1 The articular surface roughness Ra value of partial or full knee joint prostheses metal or ceramic femoral components shall be no greater than 0.1µm.

8.5 Dimensions and tolerances on important positions

8.5.1 The dimension marking shall be performed as per the requirements of YY/T 0924.1; the manufacturer shall specify the dimension and tolerance range of the corresponding product; the inspection of dimension and tolerance on each position shall be tested with general measuring tool, special inspecting tool or measuring instrument.

8.6 Dynamic performance

8.6.1 Test principles

When testing the dynamic performance, the worst case (for instance, the stress level is largest, and wearing degree is most serious) in the same serial prostheses shall be tested correspondingly. The evaluation of worst case shall be performed with combination of product expected performance and design attributes by the finite element analysis and other inspection method.

8.6.3 Wear test for full knee replacement (recommended)

The wear characteristics of full knee replacement consisting of metal or ceramic femoral components or tibial components shall be tested as per ISO 14243-1, ISO 14243-2 and ISO 14243-3.

8.7 Relative angular motion range

The relative angular motion range between femoral component and tibial component shall be tested as per the provisions of ISO 21534; YY/T 0919 gives an applicable method for measuring the range of motion of a fully constrained knee joint.

9 Manufacture

It shall meet the requirements of YY/T 0919. […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY 0118-2026|YY/T 0919-2014|YY/T 1647-2019|YY/T 1634-2018|YY/T 0963-2014|YY/T 1426.3-2017

Editions of YY 0502

Edition	Title	Revision	Status
YY 0502-2016	Joint replacement implants—Knee joint prostheses	current edition	Current
YY 0502-2005	Joint replacement implants—Knee joint prostheses	previous edition	Superseded

This page sells the current edition, YY 0502-2016. Earlier editions are listed for reference only.

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