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YY/T 0809.2-2020 English PDF (YYT0809.2-2020)

YY/T 0809.2-2020 English PDF (YYT0809.2-2020)

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YY/T 0809.2-2020: Implants for surgery -- Partial and total hip joint prostheses -- Part 2: Articulating surfaces made of metallic, ceramic and plastics materials

YY/T 0809.2-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY/T 0809.2-2010
Implants for surgery - Partial and total hip joint prostheses -
Part 2: Articulating surfaces made of metallic, ceramic and
plastics materials
(ISO 7206-2:2011+AMD 1:2016, MOD)
节面
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: SEPTEMBER 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Requirements and methods ... 7
Annex A (normative) Determination of radial separation value ... 11
Implants for surgery - Partial and total hip joint prostheses -
Part 2: Articulating surfaces made of metallic, ceramic and
plastics materials
1 Scope
This part of YY/T 0809 specifies requirements for the articulating surfaces of those types of total and partial hip joint prostheses that provide a joint replacement of ball and socket configuration, as follows:
a) sphericity and surface finish requirements for metallic and ceramic femoral prostheses for partial hip joint replacement that are in accordance with classification a) of YY/T 0809.1-2010;
b) sphericity and surface finish requirements for bipolar heads with plastics inner surfaces which articulate on femoral components that are in accordance with classification a) of YY/T 0809.1-2010 and with metallic or ceramic outer surfaces which articulate on the biological acetabulum;
c) sphericity and surface finish requirements and dimensional tolerances for plastics acetabular components that are in accordance with classification b) of YY/T 0809.1-2010;
d) sphericity and surface finish requirements and dimensional tolerances for metallic or ceramic femoral components of total hip joint prostheses that are in accordance with classification c) of YY/T 0809.1-2010.
This Part is applicable to articulating surfaces of all types of total and partial hip joint prostheses that provide a joint replacement of ball and socket configuration. 2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 3505, Geometrical product specifications (GPS) - Surface texture: Profile method - Terms definitions and surface texture parameters (GB/T 3505-2009, ISO 4287:1997, IDT)
GB/T 10610-2009, Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture (ISO 4288:1996, IDT)
YY/T 0809.1-2010, Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions (ISO 7206-1:2008, IDT)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0809.1- 2010 and the following apply.
3.1
spherical pole
Point created by the intersection of the axis of symmetry of the partial sphere of the head or cup with the spherical surface of the head or cup.
4 Requirements and methods
4.1 Femoral components of total hip joint prostheses
Note: This subclause refers to spherical articulating surfaces of femoral components of total hip joint prostheses in accordance with classification c) of YY/T 0809.1- 2010.
4.1.1 Sphericity
When measured in accordance with the method given in A.1, the departure from sphericity of the spherical articulating surface of a femoral component shall have a radial separation value not greater than 10 μm, as shown in Formula (A.1) of Appendix A.
4.1.2 Surface finish
The principles for the surface finish measurements of hip joint prostheses components are given in GB/T 3505. Surface finish measurements shall be performed according to the rules and procedures described in GB/T 10610-2009.
The spherical articulating surfaces of metallic and ceramic components shall have Ra values not greater than 0.05 μm and 0.02 μm, respectively. GB/T 10610-2009, Table 1, requires using a cut-off value of 0.25 mm for the 0.05 μm requirement and requires using a cut-off value of 0.08 mm for the 0.02 μm requirement. The Rt value shall not be greater than 1.0 μm. The cut-off value used to determine the Rt value shall be in accordance with GB/T 10610-2009, Table 2.
b) position of measurement on specimen;
c) average Ra of the five locations measured.
When examined by normal or corrected vision, the articulating surface shall be free from embedded particles and from scratches and score marks other than those arising from the finishing process.
4.2.3 Dimensional tolerances
The spherical socket shall have a diameter equal to the nominal diameter within a tolerance of +0.1 mm ~ +0.3 mm at a temperature of 20 °C ± 2 °C (i.e., it shall be oversized within the given tolerance).
4.3 Femoral prostheses for partial joint replacements
Note: This subclause refers to spherical articulating surfaces of femoral prostheses for partial joint replacements in accordance with classification a) of YY/T 0809.1- 2010.
4.3.1 Sphericity
When measured in accordance with the method given in A.1, the departure from sphericity of the spherical articulating surface shall have a radial separation value no greater than 100 μm, as shown in Formula (A.1) of Appendix A.
4.3.2 Surface finish
The principles for the surface finish measurements of hip joint prostheses components are given in GB/T 3505. Surface finish measurements shall be performed according to the rules and procedures described in GB/T 10610-2009.
The spherical articulating surface of the implant shall have an Ra value not greater than 0.5 μm using a cut-off value of 0.8 mm. The Rt value shall not be greater than 1.0 μm. The cut-off value used to determine the Rt value shall be in accordance with GB/T 10610-2009, Table 2.
The measurements shall be taken at five locations on the spherical surface. One measurement shall be taken in each of four quadrants approximately 30° from the spherical pole and one at the spherical pole. The following details shall be reported along with the measured values:
a) stylus tip radius;
b) position of measurement on specimen;
c) average Ra of the five locations measured.
When examined by normal or corrected vision, the articulating surface shall be free from embedded particles and from scratches and score marks other than those arising from the finishing process.
4.3.3 Dimensional tolerances
The tolerance for the spherical head shall be ±0.5 mm on the nominal diameter. 4.4 Bipolar heads
Note: This subclause refers to bipolar heads for femoral prostheses consisting of a concave (inner) spherical surface in a plastics component intended to articulate with a femoral component of a partial or total hip joint. The bipolar head also has a convex (outer) spherical surface which is intended to articulate with the biological acetabulum.
4.4.1 Inner articulating surface
The inner articulating surface of the plastics part of a bipolar head shall conform to 4.2. 4.4.2 Outer articulating surface
The outer articulating surface of a bipolar head shall conform to 4.3.
4.5 Metallic and ceramic acetabular components of total hip joint prostheses Note: This subclause refers to spherical articulating surfaces of acetabular components of total hip joint prosthesis with classification c) of YY/T 0809.1-2010. 4.5.1 Surface finish
The principles for the surface finish measurements of hip joint prostheses components are given in GB/T 3505. Surface finish measurements shall be performed according to the rules and procedures described in GB/T 10610-2009.
The spherical articulating surfaces of metallic and ceramic components shall have an Ra value not greater than 0.05 μm using a cut-off value of 0.25 mm.

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