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[Medicine] yy0118 hip prosthesis

Nickel Titanium Alloy 2021-06-24 08:06 128
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1. Ics11.040.40c 35yy the pharmaceutical industry standard of the people's Republic of China YY XXXXXXXX replaces YY 0118-2005 joint replacement implants hip joint prostheses xxxxx - XX - XX issue Classification and dimensioning 34 expected performance 35 design attribute 36 material 37 design evaluation 58 manufacturing 79 sterilization 710 packaging 811 information provided by manufacturer 8 Appendix A (normative appendix) list of approved material standards for manufacturing hip prosthesis 9 Appendix B (normative appendix) list of approved and non approved materials for manufacturing hip prosthesis joint surface

2. Table 10 Appendix C (normative appendix) list of approved and disapproved metal combinations of non joint contact surface of hip prosthesis 11 Appendix D (informative appendix) list of approved methods and standards for chemical analysis 12 preface this standard is drafted according to the rules given in GB / T 1.12009. This standard is revised on the basis of YY 01182005 standard for hip prosthesis. The main difference between this standard and YY 01182005 is that the format of this standard is revised according to the format of ISO 21534. The evaluation of oxidation stability and morphology of UHMWPE was added (see 6.3.1); The requirements of high dose radiation crosslinking UHMWPE and plasma spraying metal coating are added (see 6.3.2 and 6.5.2); The application scope of surface defects is revised (see 7.3, 4.2.2 of 2005 Edition) and added

3. The anti torque performance of femoral head fixation, the anti static load performance of combined femoral head and the anti deformation performance of metal acetabulum were measured( See 7.6.1, 7.6.2, 7.6.3) to revise the fatigue performance of the stem of the femoral component with stem and change it into a mandatory clause( See 7.7.2, 2005 edition 5.3.1) to revise the head and neck fatigue performance of the femoral component with stem and make it mandatory( See 7.7.3, 2005 Edition 5.3.2) added minimum and maximum angles(

4. (SAC / TC110 / SC1) centralized. This standard is drafted by: this standard is mainly drafted by: this standard replaces and repeals YY 01182005. The previous release of YY 0118 is YY 01181993; YY 01182005。

5. For this document. GB / T 10610 geometrical product specification (GPS) rules and methods for evaluating surface structure by surface profile method (ISO 4288) GB / T 14233.1 test methods for medical infusion, blood transfusion and injection apparatus part 1: chemical analysis methods GB / T 14233.2 medical infusion, blood transfusion and injection apparatus Test methods for injection devices Part 2: biological test methods GB / T 16886.7 biological evaluation of medical devices Part 7: ethylene oxide sterilization residue (ISO 10993-7) GB 18278 sterilization confirmation and routine control requirements for medical and health care products Industrial moist heat sterilization (ISO 11134) GB 18279 sterilization confirmation and routine control of ethylene oxide for medical devices (ISO 11135) GB 18280 medical and health care products Sterilization confirmation and routine control should be carried out

6. Radiation sterilization (ISO 11137) GB / T 19701.1 ultra high molecular weight polyethylene part 1: powder (ISO 5834-1) GB / T 19701.2 ultra high molecular weight polyethylene part 2: molding compound (ISO 5834-2) GB 23101.2 surgical implants hydroxyapatite Part 2: hydroxyapatite coating (ISO 13779-2) YY 0117.1 surgical implants bone and joint prosthesis forging Casting Ti6Al4V titanium alloy forging YY 0117.2 surgical implant bone and joint prosthesis forging, casting zti6al4v titanium alloy casting YY 0117.3 surgical implant bone and joint prosthesis forging, Casting Co Cr Mo alloy casting YY / T 0343 surgical metal implant liquid penetrant inspection (ISO 9583) YY / T 0772.3 surgical implant

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8、 ISO 6474-1 ceramic materials for surgical implants Part 1: ceramic materials based on high purity alumina ISO 6474-2 ceramic materials for surgical implants Part 2: zirconia reinforced high purity alumina composites als Part 2: Composite materials based on a high purity 。

9. ISO 7206-1 implants for surgery partial and total hip joint protheses Part 1: classification and design of dimensions Implants for surgery partial and total hip joint protheses Part 2:

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11、 ISO 7206-10 surgical implants and total hip joint prostheses Part 10: implants for surgerypartial and total hip joint prostheses Part 10: Determination of resistance ance to sta。

12、 (TIC load of modular femoral heads) ISO 13356 surgical implants Y-TZP (implants for surgeryceramic materials based on yttria stabilized triangular zirconia (Y-TZP) ISO 14242-1 surgical implants total hip prosthesis wear part 1: load and displacement parameters of wear tester and corresponding test environmental conditions (IMP lants for surgeryWear of total hip-joint prosthesesPart 1: Loading and displace。

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14、 Al hip joint prostheses Part 3: loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test tsJoint r。

15、 ISO 21535 non active surgical implants joint replacement implants specific requirements for hip joint replacement implants ASTM f1044 Standard Test Method for shear testing of calcium phosphate coating and metal coating calcium phosphate coating and metallic。 ASTM f1147 Standard Test Method for tension testing of calcium phosphate coating and metallic coating Standard Test Method for shear and bending testing of calcium phosphate and metallic medical and composite calcium phosphate

17、 ASTM f1377 Standard Specification for cobalt-28chromium-6molybdenum powder for coating of orthopedic implants ASTM f1580 Standard Specification for titanium and TITANIUM-6ALUMINUM-4VANADIUM alloy powder for coating of surgical implants ants)ASTM F。

18、 Terms of

19, 1534, ISO 21535 and ISO 7206-1

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