Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
YY/T 0809 consists of the following parts, under the general title Implants for surgery - Partial and total hip joint prostheses:
——Part 1: Classification and designation of dimensions;
——Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
——Part 3: (Reserved);
——Part 4: Determination of endurance properties and performance of stemmed femoral components;
——Part 5: (Reserved);
——Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components;
——Part 7: (Reserved);
——Part 8: Endurance performance of stemmed femoral components with application of torsion;
——Part 9: (Reserved);
——Part 10: Determination of resistance to static load of modular femoral heads;
——Part 11:
——Part 12: Deformation test method for acetabular shells;
——Part 13: Determination of resistance to torque of head fixation of stemmed femoral components.
This is Part 12 of YY/T 0809.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This standard has been redrafted and modified in relation to ISO 7206-12: 2016 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells.
The following main technical changes have been made with respect to ISO 7206-12:2016:
——The adjustment on technical differences are made for the normative references of this Part to adapt to the technical conditions in China. The adjustments are mainly reflected in clause 2 "Normative references", which are shown as follows:
ISO 2768-2 is replaced by GB/T 1184 which is adjusted into the Bibliography.
ISO 21534 is replaced by GB/T 12417.2, which is identical to the international standard;
ISO 7206-1 is replaced by YY/T 0809.1, which is identical to the international standard;
ISO 7206-2 is replaced by YY/T 0809.2, which is modified in relation to the international standard;
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of SAC/TC 110/SC 1 the Subcommittee on Orthopaedic Implants of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China.
Implants for surgery - Partial and total hip joint prostheses -
Part 12: Deformation test method for acetabular shells
1 Scope
This part of YY/T 0809 specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. Furthermore, this part specifies the test parameters of press-fit acetabular components tested in accordance with this part.
The test method is intended to be used to evaluate the comparison of various designs and materials used for acetabular components in total hip joint replacement when tested under similar conditions.
The loading of the acetabular components in vivo will, in general, differ from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance.
This part does not cover methods of examining the test specimen.
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 12417.2 Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2: Particular requirements for joint replacement implants (GB/T 12417.2-2008, ISO 21534: 2002, IDT)
YY/T 0809.1 Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions (YY/T 0809.1-2010, ISO 7206-1: 2008, IDT)
YY/T 0809.2 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials (YY/T 0809.2-2010, ISO 7206-2: 1996, MOD)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0809.1, YY/T 0809.2 and GB/T 12417.2 and the following, apply.
3.1
metal backing deformation
amount of geometrical deviation (inner diameter and circularity of metal backing in a defined measurement plane) from design specifications under loading conditions
3.2
spherical socket deformation
articulating surface deformation
amount of geometrical deviation (diameter and circularity in a defined measurement plane) from design specifications under loading conditions
3.3
frontal face reference plane
plane, perpendicular to the component polar axis, nominally at the frontal face level (see Figure 1a))
Note 1: In case of doubt, the polar axis can be defined as a straight line perpendicular to the plane spanning around the contact zone of the acetabular component to the cortical bone, and passing through the centre point of the ball sphere approximating the acetabular component’s outer sphere.
Note 2: In case of an asymmetrically shaped front face, e.g. anatomically shaped acetabular components, the frontal face reference plane can be located at a level, which contains the largest part of the frontal face that is perpendicular to the component polar axis (see Figures 1b) and 1c)).
Note 3: In case the frontal face does not contain any part perpendicular to the component axis, the frontal face reference plane can be located at that level perpendicular to the polar axis at the approximated middle between the highest and the lowest point of the frontal face (see Figure 1d)).
Note: Marked (shaded) areas of the frontal face are located in the reference plane.
Figure 1 Frontal face reference plane of acetabular components
3.4
loading plane
plane, parallel to the frontal face reference plane and located in an area where the acetabular cup gets in contact with the cortical bone after being properly and fully seated intraoperatively
Example: For symmetrically shaped acetabular components, Figure 1a), the loading plane will usually be located close to the frontal face reference plane.
3.5
measurement plane
plane, parallel to the frontal face reference plane, located with a certain distance to the frontal face reference plane but as close as possible to the frontal face reference plane
Note 1: The sensitivity of the deformation measurement decreases with increasing distance of the measurement plane from the front face reference plane and with decreasing distance of the measurement plane to the top of the cup.
Note 2: Within the measurement plane, the measurement points for determining the inner diameter of the test specimen can be captured. Therefore, the measurement plane can be defined so that capturing the measurement points is not disturbed by any design features of the test specimen as holes or cut-outs. The measurement points can be captured at the test specimen directly; they cannot be captured at the load frame.
4 Principle
The test specimen is subjected to diametrically opposite two-point loading. For the determination of short-term deformation, measurements of diameter in loading direction in a defined measurement plane are carried out prior and under loading, as well as after unloading. This deformation measurement procedure is repeated two times after rotating the specimen with rotation angles of itself, of which each rotation angle measures 120° to account for influence of asymmetric design features as fins, holes, etc.
Metal-backed modular acetabular components can deform and affect the seating of the insert. The combination of metal-backing and insert can deform and affect the tribology. So such components shall be tested in two steps: first step, testing of the metal backing alone; second step, testing of the metal backing with the appropriately mounted bearing insert.
Press-fit installation of monoblock acetabular cup components can cause deformation of the articular surface which may affect tribology. Such components shall be tested in only one step.
5 Apparatus
5.1 Loading device
A load frame capable of the following functionality:
a) shall not exhibit any visible and irreversible deformation under loading the test specimen;
b) shall allow reproducible loading and unloading of a test specimen along a defined mechanical axis and measuring loads and distances, respectively;
c) shall be capable of loading acetabular cups up to a diameter of 100 mm and a height of 50 mm.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Principle 5 Apparatus 6 Procedure 7 Report Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
YY/T 0809 consists of the following parts, under the general title Implants for surgery - Partial and total hip joint prostheses:
——Part 1: Classification and designation of dimensions;
——Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
——Part 3: (Reserved);
——Part 4: Determination of endurance properties and performance of stemmed femoral components;
——Part 5: (Reserved);
——Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components;
——Part 7: (Reserved);
——Part 8: Endurance performance of stemmed femoral components with application of torsion;
——Part 9: (Reserved);
——Part 10: Determination of resistance to static load of modular femoral heads;
——Part 11:
——Part 12: Deformation test method for acetabular shells;
——Part 13: Determination of resistance to torque of head fixation of stemmed femoral components.
This is Part 12 of YY/T 0809.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This standard has been redrafted and modified in relation to ISO 7206-12: 2016 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells.
The following main technical changes have been made with respect to ISO 7206-12:2016:
——The adjustment on technical differences are made for the normative references of this Part to adapt to the technical conditions in China. The adjustments are mainly reflected in clause 2 "Normative references", which are shown as follows:
ISO 2768-2 is replaced by GB/T 1184 which is adjusted into the Bibliography.
ISO 21534 is replaced by GB/T 12417.2, which is identical to the international standard;
ISO 7206-1 is replaced by YY/T 0809.1, which is identical to the international standard;
ISO 7206-2 is replaced by YY/T 0809.2, which is modified in relation to the international standard;
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of SAC/TC 110/SC 1 the Subcommittee on Orthopaedic Implants of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China.
Implants for surgery - Partial and total hip joint prostheses -
Part 12: Deformation test method for acetabular shells
1 Scope
This part of YY/T 0809 specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. Furthermore, this part specifies the test parameters of press-fit acetabular components tested in accordance with this part.
The test method is intended to be used to evaluate the comparison of various designs and materials used for acetabular components in total hip joint replacement when tested under similar conditions.
The loading of the acetabular components in vivo will, in general, differ from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance.
This part does not cover methods of examining the test specimen.
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 12417.2 Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2: Particular requirements for joint replacement implants (GB/T 12417.2-2008, ISO 21534: 2002, IDT)
YY/T 0809.1 Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions (YY/T 0809.1-2010, ISO 7206-1: 2008, IDT)
YY/T 0809.2 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials (YY/T 0809.2-2010, ISO 7206-2: 1996, MOD)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0809.1, YY/T 0809.2 and GB/T 12417.2 and the following, apply.
3.1
metal backing deformation
amount of geometrical deviation (inner diameter and circularity of metal backing in a defined measurement plane) from design specifications under loading conditions
3.2
spherical socket deformation
articulating surface deformation
amount of geometrical deviation (diameter and circularity in a defined measurement plane) from design specifications under loading conditions
3.3
frontal face reference plane
plane, perpendicular to the component polar axis, nominally at the frontal face level (see Figure 1a))
Note 1: In case of doubt, the polar axis can be defined as a straight line perpendicular to the plane spanning around the contact zone of the acetabular component to the cortical bone, and passing through the centre point of the ball sphere approximating the acetabular component’s outer sphere.
Note 2: In case of an asymmetrically shaped front face, e.g. anatomically shaped acetabular components, the frontal face reference plane can be located at a level, which contains the largest part of the frontal face that is perpendicular to the component polar axis (see Figures 1b) and 1c)).
Note 3: In case the frontal face does not contain any part perpendicular to the component axis, the frontal face reference plane can be located at that level perpendicular to the polar axis at the approximated middle between the highest and the lowest point of the frontal face (see Figure 1d)).
Note: Marked (shaded) areas of the frontal face are located in the reference plane.
Figure 1 Frontal face reference plane of acetabular components
3.4
loading plane
plane, parallel to the frontal face reference plane and located in an area where the acetabular cup gets in contact with the cortical bone after being properly and fully seated intraoperatively
Example: For symmetrically shaped acetabular components, Figure 1a), the loading plane will usually be located close to the frontal face reference plane.
3.5
measurement plane
plane, parallel to the frontal face reference plane, located with a certain distance to the frontal face reference plane but as close as possible to the frontal face reference plane
Note 1: The sensitivity of the deformation measurement decreases with increasing distance of the measurement plane from the front face reference plane and with decreasing distance of the measurement plane to the top of the cup.
Note 2: Within the measurement plane, the measurement points for determining the inner diameter of the test specimen can be captured. Therefore, the measurement plane can be defined so that capturing the measurement points is not disturbed by any design features of the test specimen as holes or cut-outs. The measurement points can be captured at the test specimen directly; they cannot be captured at the load frame.
4 Principle
The test specimen is subjected to diametrically opposite two-point loading. For the determination of short-term deformation, measurements of diameter in loading direction in a defined measurement plane are carried out prior and under loading, as well as after unloading. This deformation measurement procedure is repeated two times after rotating the specimen with rotation angles of itself, of which each rotation angle measures 120° to account for influence of asymmetric design features as fins, holes, etc.
Metal-backed modular acetabular components can deform and affect the seating of the insert. The combination of metal-backing and insert can deform and affect the tribology. So such components shall be tested in two steps: first step, testing of the metal backing alone; second step, testing of the metal backing with the appropriately mounted bearing insert.
Press-fit installation of monoblock acetabular cup components can cause deformation of the articular surface which may affect tribology. Such components shall be tested in only one step.
5 Apparatus
5.1 Loading device
A load frame capable of the following functionality:
a) shall not exhibit any visible and irreversible deformation under loading the test specimen;
b) shall allow reproducible loading and unloading of a test specimen along a defined mechanical axis and measuring loads and distances, respectively;
c) shall be capable of loading acetabular cups up to a diameter of 100 mm and a height of 50 mm.
Contents of YY/T 0809.12-2020
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Apparatus
6 Procedure
7 Report
Bibliography
