YY 0118-2016Joint replacement implants - Hip joint prostheses (English PDF)

3.1 Conventional UHMWPE

UHMWPE manufactured through molding or extrusion forming, undergone no cross-linked treatment before the final sterilization.

3.2 Extensively radiation-cross-linked UHMWPE

UHMWPE manufactured through molding or extrusion forming, and to improve the wear resistance by using gamma ray or electron beam irradiation of which the dosage is higher than 40kGy.

4.1 Classification

It shall conform to the requirements of YY/T 0809.1.

4.2 Size marking

It shall conform to the requirements of YY/T 0809.1.

7.1 General

coating.

8.4 Surface roughness

8.4.1 Articulating surface roughness

8.4.1.1 As for spherical articulating surface of metallic and ceramic femoral

components matched the plastic acetabular components in the total hip joint prostheses, its surface roughness Ra shall be no more than 0.05µm and

0.02µm respectively.

8.4.1.2 As for spherical articulating surface of plastic acetabular components

in total hip joint prostheses, it surface roughness Ra is no more than 2µm.

8.4.1.3 As for spherical articulating surface of metallic and ceramic femoral

components matched the physiological acetabular components in the partial hip joint prostheses, its surface roughness Ra shall be no more than 0. 5µm.

8.4.1.4 As for concave (internal) spherical articulating surface of bipolar head

plastic component, its surface roughness Ra shall be no more than 2µm.

8.4.1.5 As for spherical articulating surface of metallic and ceramic femoral

components with bipolar head matched physiological acetabular, its surface roughness Ra shall be no more than 0.5µm.

8.4.1.6

Manufacturer shall specify the surface roughness R a of the ceramic-to-ceramic articulating surface, and metallic-to-metallic articulating surface.

Note: the surface roughness of articulating surface shall be tested as per the method specified in

YY/T 0809.2.

8.4.2 Tapered joint surface roughness

Manufacturer shall specify the requirements of tapered joint surface roughness

Ra and/or Rz , which shall be tested as per the method specified in GB/T 10610.

8.4.3 Coating surface roughness

Manufacturer shall specify the requirements of coating surface roughness R a or Rz , which shall be tested as per the method specified in GB/T 10610.

8.5 Dimensions and tolerances of important parts

Test of each part’s dimension and tolerance is implemented through the measuring tool, special gages or measuring instrument, while spherical roundness radial deviation of articulating surface shall be carried out as per the provision in YY/T 0809.2.

--- 6mm is applicable to the components without rear lining.

8.5.5 Bipolar head

As for the bipolar head with outer diameter 44m or larger, the minimum thickness of its liner manufactured by conventional UHMWP shall be 5mm.

Note: when special people’s bone size needs implants, the acetabular component diameter is less than 42mm, and bipolar head component diameter is less than 44mm; then thickness of component manufactured by conventional UHMWP can be less than the above-mentioned value.

8.6 Static mechanical properties

8.6.1 Femoral fixed anti-torque performance measurement of stemmed

femoral components

Note: Relevant standard of test method is under preparation, which shall be implemented after the publication.

Combined femoral anti-static load force

It shall be carried out as per the method specified in ISO 7206-10.

8.6.3 Metal acetabular resistance to deformation

Note: Relevant standard of test method is under preparation, which shall be implemented after the publication.

8.7 Dynamic performance

8.7.1 Test principle

When dynamic performance test is carried out, it shall test the same series of prostheses’ worst situations (such as maximum stress level, most serious wearing and etc.). The evaluation of worst situation shall combine the product’s expected performance, design attributes, and adopt the finite element analysis method or other verification methods.

8.7.2 Stem fatigue performance of stemmed femoral component

Stem fatigue performance of stemmed femoral component shall test as per

ISO 7206-4, and shall conform to the requirements.

8.7.3 Head and neck fatigue performance of stemmed femoral

component

Head and neck fatigue performance of stemmed femoral component shall test as per ISO 7206-6, and shall conform to the requirements.

Appendix A (Normative)

List of Material Standards That Are Acceptable for the Manufacture of Hip

Joint Prostheses

The following materials have been found acceptable through proven use for the manufacture of hip joint prostheses.

The inclusion of materials in this appendix does not imply their satisfactory use in any particular application; neither does it relieve the manufacturer from the obligation to undertake a design evaluation.

ISO 5832-1 Implants for Surgery - Metallic Materials - Part 1: Wrought

Stainless Steel

ISO 5832-2 Implants for Surgery - Metallic Materials - Part 2: Unalloyed

Titanium

ISO 5832-3 Implants for Surgery - Metallic Materials - Part 3: Wrought Titanium

6-aluminium 4-vanadium Alloy

ISO 5832-4 Implants for Surgery - Metallic Materials - Part 4:

Cobalt-chromium-molybdenum Casting Alloy

ISO 5832-5 Implants for Surgery - Metallic Materials - Part 5: Wrought

Cobalt-chromium-tungsten-nickel Alloy

ISO 5832-6 Implants for Surgery - Metallic Materials - Part 6: Wrought

Cobalt-nickel-chromium-molybdenum Alloy

ISO 5832-7 Implants for Surgery - Metallic Materials - Part 7: Forgeable and

Cold-formed Cobalt-chromium-nickel-molybdenum-iron Alloy

ISO 5832-8 Implants for Surgery - Metallic Materials - Part 8: Wrought

Cobalt-nickel-chromium-molybdenum-tungsten-iron Alloy

ISO 5832-9 Implants for Surgery - Metallic Materials - Part 9: Wrought High

Nitrogen Stainless Steel

ISO 5832-11 Implants for Surgery - Metallic Materials - Part 11: Wrought

Titanium 6-aluminium 7-niobium Alloy

ISO 5832-12 Implants for Surgery - Metallic Materials - Part 12: Wrought

Appendix B (Normative)

List of Materials That Are Acceptable or not Acceptable for the

Manufacture of Articulating Surfaces of Hip Joint Prostheses

B.1 Suitable material combinations

For the articulating surfaces of hip joint replacement implants, the following combinations of the materials listed in Appendix A have been found to be acceptable in particular applications, provided that adequate attention is paid to in design, surface finish and surface treatment:

a) Wrought stainless steel (ISO 5832-1) / UHMWPE (ISO 5834-1, ISO

5834-2);

b) Wrought high nitrogen stainless steel (ISO 5832-9) / UHMWPE (ISO

5834-1, ISO 5834-2);

c) Cobalt-chromium-molybdenum casting alloy (ISO 5832-4, GB 17100) /

UHMWPE (ISO 5834-1, ISO 5834-2);

d) Wrought cobalt-chromium tungsten-nickel alloy (ISO 5832-5) /

UHMWPE (ISO 5834-1, ISO 5834-2);

e) Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7) / UHMWPE (ISO 5834-1, ISO 5834-2);

f) Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy (ISO

5832-8) / UHMWPE (ISO 5834-1, ISO 5834-2);

g) Wrought titanium 6-aluminium 4-vanadium alloy

1 ) (ISO 5832-3) /

UHMWPE (ISO 5834-1, ISO 5834-2);

h) Wrought titanium 6-aluminium 7-niobium alloy

1) (ISO 5832-11) /

UHMWPE (ISO 5834-1, ISO 5834-2);

i) Ceramic materials based on alumina (ISO 6474) / UHMWPE (ISO

5834-1, ISO 5834-2);

j) Ceramic materials based on zirconia (ISO 13356) / UHMWPE (ISO

5834-1, ISO 5834-2);

1)

Particular attention to surface treatment of the articulating surface may be necessary.