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.
7.7.4 of this standard is recommendatory, and the rest are compulsory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0118-2005 Hip joint prostheses, and the following main technical changes have been made with respect to YY 0118-2005:
——The evaluation of oxidative stability and morphology of ultrahigh molecular weight polyethylene (UHMWPE) materials is added (see 7.3.1);
——The requirements for extensively radiation-cross-linked UHMWPE are added (see 7.3.2);
——The requirements for plasma-sprayed metallic coating are added (see 7.5.2);
——The application scope of surface defects is revised (see 8.3 hereof and 4.2.2 of Edition 2005);
——The determination of anti-torque properties for femoral head fixation of stemmed femoral components is added (see 8.6.1);
——The resistance to static load of modular femoral heads is added (see 8.6.2);
——The resistance to deformation of metallic acetabulum is added (see 8.6.3);
——The endurance properties of stem region of stemmed femoral components are revised and changed to be mandatory (see 8.7.2 hereof and 5.3.1 of Edition 2005);
——The endurance properties of head and neck region of stemmed femoral components are revised and changed to be mandatory (see 8.7.3 hereof and 5.3.2 of Edition 2005);
——The minimum and maximum angles are added (see 8.8 hereof);
——The inspection rules of the former standard are deleted (see Clause 7 of Edition 2005).
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 standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of the Subcommittee on Orthopaedic Implants of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China (SAC/TC 110/SC 1).
The previous editions of the standard replaced by this standard are as follow:
——YY 0118-1993, YY 0118-2005.
Joint replacement implants—
Hip joint prostheses
1 Scope
This standard specifies the terms and definitions and requirements for classification and designation of dimensions, expected properties, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer of partial and total hip joint prostheses.
This standard is applicable to partial and total hip joint prostheses made of materials and by processes specified in this standard.
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 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 equipments 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
GB 18279 Medical devices—Validation and routine control of ethylene oxide sterilization
GB 18280 Sterilization of health care products—Requirements for validation and routine control—Radiation sterilization
GB/T 19701.1 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form
GB/T 19701.2 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded forms
GB 23101.2 Implants for surgery—Hydroxyapatite—Part 2: Coatings of hydroxyapatite
YY 0117.1 Implants for surgery—Forgings, castings for bone joint prostheses—Ti6Al4V titanium alloy forgings
YY 0117.2 Implants for surgery—Forgings, castings for bone joint prostheses—ZTi6Al4V titanium alloy castings
YY 0117.3 Implants for surgery—Forgings, castings for bone joint prostheses—Cobalt chromium molybdenum alloy castings
YY/T 0343 Liquid penetrant inspection of metallic surgical implants
YY/T 0772.3 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 3: Accelerated ageing methods
YY/T 0772.4 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 4: Oxidation index measurement method
YY/T 0772.5 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 5: Morphology assessment method
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, IDT)
YY/T 0811 Standard guide for extensively irradiation-Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
YY/T 0920 Non-active surgical implants—Joint replacement implants—Specific requirements for hip-joint replacement implants (YY/T 0920-2014, ISO 21535:2007, IDT)
ISO 4287 Geometrical product specification (GPS)—Surface texture: Profile method—Terms, definitions and surface texture parameters
ISO 6474-1 Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity alumina
ISO 6474-2 Implants for surgery—Ceramic materials—Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcement
ISO 7206-4 Implants for surgery—Partial and total hip joint prostheses—Part 4: Determination of endurance properties of stemmed femoral components
ISO 7206-6 Implants for surgery—Partial and total hip joint prostheses—Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
ISO 7206-10 Implants for surgery—Partial and total hip joint prostheses—Part 10: Determination of resistance to static load of modular femoral heads
ISO 13356 Implants for surgery—Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
ISO 14242-1 Implants for surgery—Wear of total hip-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines corresponding environmental conditions for test
ISO 14242-2 Implants for surgery—Wear of total hip-joint prostheses—Part 2: Methods of measurement
ISO 14242-3 Implants for surgery—Wear of total hip-joint prostheses—Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test
ISO 14630 Non-active surgical implants—General requirements
ISO 21534 Non-active surgery Implants—Joint replacement implants—Particular requirements
ASTM F1044 Standard test method for shear testing of calcium phosphate coating and metallic coating
ASTM F1147 Standard test method for tension testing of calcium phosphate coating and metallic coating
ASTM F1160 Standard test method for shear and bending testing of calcium phosphate and metallic medical and composite calcium phosphate/metallic coating
ASTM F1377 Standard specification for cobalt-28 chromium-6 molybdenum powder for coating of orthopedic implants
ASTM F1580 Standard specification for titanium and titanium-6 aluminum-4 vanadium alloy powders for coating of surgical implants
ASTM F1854 Standard test method for stereo-logical evaluation of porous coating on medical implants
ASTM F1978 Standard test method for measuring abrasion resistance of metallic thermal spray coatings by using the Taber abraser
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0809.1, YY/T 0920 and ISO 21534 and the following apply.
3.1
conventional UHMWPE
UHMWPE manufactured by mould pressing or extrusion molding and not crosslinked prior to final sterilization
3.2
extensively radiation-cross-linked UHMWPE
UHMWPE manufactured by mould pressing or extrusion molding and subjected to irradiation from gamma rays or electron beam at a dose of more than 40 kGy for improving wear resistance
4 Classification and designation of dimensions
4.1 Classification
It shall comply with the requirements of YY/T 0809.1.
4.2 Designation of dimensions
It shall comply with the requirements of YY/T 0809.1.
5 Expected properties
It shall comply with the requirements of YY/T 0920.
6 Design attributes
It shall comply with the requirements of YY/T 0920.
7 Materials
7.1 General
It shall comply with the requirements of YY/T 0920 and the following requirements.
7.2 Metallic materials
7.2.1 The chemical compositions of the metallic materials used for manufacturing hip joint prostheses shall comply with the requirements of corresponding standards.
7.2.2 The microscopic structure of forgings and processing materials shall comply with the requirements of corresponding standards.
7.2.3 The mechanical properties shall comply with the requirements of corresponding standards.
7.2.4 The internal quality of castings shall comply with the requirements of corresponding standards.
Note 1: As for hip joint prostheses made of Ti6Al4V titanium alloy forgings, ZTi6Al4V titanium alloy castings or cobalt-chromium-molybdenum alloy castings, their chemical compositions, mechanical properties, microscopic structure of forgings and internal quality of castings shall comply with the requirements of YY 0117.1~YY 0117.3.
Note 2: The samples required for inspection of the above items shall be taken from the product body. If some parts cannot be sampled on the body due to structure or dimensions, etc., they can be made on the same batch of blanks, cast-in-place samples or raw materials.
Note 3: The sample for tensile test is cut from the castings for inspection of mechanical properties, and the indicators of mechanical properties (Rm, Rp0.2, A) are determined by the supplier and the purchaser of castings through negotiation. If this requirement does not meet the corresponding requirements of YY 0117, the dynamic mechanical property test shall comply with the requirements of 8.7.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Classification and designation of dimensions 5 Expected properties 6 Design attributes 7 Materials 8 Design evaluation 9 Manufacturing 10 Sterilization 11 Packaging 12 Information provided by the manufacturer Annex A (Normative) List of standards for materials approved for the manufacture of hip joint prostheses Annex B (Normative) List of materials approved and unapproved for the manufacture of articulating surfaces of hip joint prostheses Annex C (Normative) List of metallic combinations approved and unapproved for non-articulating surfaces of hip joint prostheses Annex D (Informative) List of approved standards for chemical analysis methods
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.
7.7.4 of this standard is recommendatory, and the rest are compulsory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0118-2005 Hip joint prostheses, and the following main technical changes have been made with respect to YY 0118-2005:
——The evaluation of oxidative stability and morphology of ultrahigh molecular weight polyethylene (UHMWPE) materials is added (see 7.3.1);
——The requirements for extensively radiation-cross-linked UHMWPE are added (see 7.3.2);
——The requirements for plasma-sprayed metallic coating are added (see 7.5.2);
——The application scope of surface defects is revised (see 8.3 hereof and 4.2.2 of Edition 2005);
——The determination of anti-torque properties for femoral head fixation of stemmed femoral components is added (see 8.6.1);
——The resistance to static load of modular femoral heads is added (see 8.6.2);
——The resistance to deformation of metallic acetabulum is added (see 8.6.3);
——The endurance properties of stem region of stemmed femoral components are revised and changed to be mandatory (see 8.7.2 hereof and 5.3.1 of Edition 2005);
——The endurance properties of head and neck region of stemmed femoral components are revised and changed to be mandatory (see 8.7.3 hereof and 5.3.2 of Edition 2005);
——The minimum and maximum angles are added (see 8.8 hereof);
——The inspection rules of the former standard are deleted (see Clause 7 of Edition 2005).
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 standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of the Subcommittee on Orthopaedic Implants of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China (SAC/TC 110/SC 1).
The previous editions of the standard replaced by this standard are as follow:
——YY 0118-1993, YY 0118-2005.
Joint replacement implants—
Hip joint prostheses
1 Scope
This standard specifies the terms and definitions and requirements for classification and designation of dimensions, expected properties, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer of partial and total hip joint prostheses.
This standard is applicable to partial and total hip joint prostheses made of materials and by processes specified in this standard.
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 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 equipments 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
GB 18279 Medical devices—Validation and routine control of ethylene oxide sterilization
GB 18280 Sterilization of health care products—Requirements for validation and routine control—Radiation sterilization
GB/T 19701.1 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form
GB/T 19701.2 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded forms
GB 23101.2 Implants for surgery—Hydroxyapatite—Part 2: Coatings of hydroxyapatite
YY 0117.1 Implants for surgery—Forgings, castings for bone joint prostheses—Ti6Al4V titanium alloy forgings
YY 0117.2 Implants for surgery—Forgings, castings for bone joint prostheses—ZTi6Al4V titanium alloy castings
YY 0117.3 Implants for surgery—Forgings, castings for bone joint prostheses—Cobalt chromium molybdenum alloy castings
YY/T 0343 Liquid penetrant inspection of metallic surgical implants
YY/T 0772.3 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 3: Accelerated ageing methods
YY/T 0772.4 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 4: Oxidation index measurement method
YY/T 0772.5 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 5: Morphology assessment method
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, IDT)
YY/T 0811 Standard guide for extensively irradiation-Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
YY/T 0920 Non-active surgical implants—Joint replacement implants—Specific requirements for hip-joint replacement implants (YY/T 0920-2014, ISO 21535:2007, IDT)
ISO 4287 Geometrical product specification (GPS)—Surface texture: Profile method—Terms, definitions and surface texture parameters
ISO 6474-1 Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity alumina
ISO 6474-2 Implants for surgery—Ceramic materials—Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcement
ISO 7206-4 Implants for surgery—Partial and total hip joint prostheses—Part 4: Determination of endurance properties of stemmed femoral components
ISO 7206-6 Implants for surgery—Partial and total hip joint prostheses—Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
ISO 7206-10 Implants for surgery—Partial and total hip joint prostheses—Part 10: Determination of resistance to static load of modular femoral heads
ISO 13356 Implants for surgery—Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
ISO 14242-1 Implants for surgery—Wear of total hip-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines corresponding environmental conditions for test
ISO 14242-2 Implants for surgery—Wear of total hip-joint prostheses—Part 2: Methods of measurement
ISO 14242-3 Implants for surgery—Wear of total hip-joint prostheses—Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test
ISO 14630 Non-active surgical implants—General requirements
ISO 21534 Non-active surgery Implants—Joint replacement implants—Particular requirements
ASTM F1044 Standard test method for shear testing of calcium phosphate coating and metallic coating
ASTM F1147 Standard test method for tension testing of calcium phosphate coating and metallic coating
ASTM F1160 Standard test method for shear and bending testing of calcium phosphate and metallic medical and composite calcium phosphate/metallic coating
ASTM F1377 Standard specification for cobalt-28 chromium-6 molybdenum powder for coating of orthopedic implants
ASTM F1580 Standard specification for titanium and titanium-6 aluminum-4 vanadium alloy powders for coating of surgical implants
ASTM F1854 Standard test method for stereo-logical evaluation of porous coating on medical implants
ASTM F1978 Standard test method for measuring abrasion resistance of metallic thermal spray coatings by using the Taber abraser
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0809.1, YY/T 0920 and ISO 21534 and the following apply.
3.1
conventional UHMWPE
UHMWPE manufactured by mould pressing or extrusion molding and not crosslinked prior to final sterilization
3.2
extensively radiation-cross-linked UHMWPE
UHMWPE manufactured by mould pressing or extrusion molding and subjected to irradiation from gamma rays or electron beam at a dose of more than 40 kGy for improving wear resistance
4 Classification and designation of dimensions
4.1 Classification
It shall comply with the requirements of YY/T 0809.1.
4.2 Designation of dimensions
It shall comply with the requirements of YY/T 0809.1.
5 Expected properties
It shall comply with the requirements of YY/T 0920.
6 Design attributes
It shall comply with the requirements of YY/T 0920.
7 Materials
7.1 General
It shall comply with the requirements of YY/T 0920 and the following requirements.
7.2 Metallic materials
7.2.1 The chemical compositions of the metallic materials used for manufacturing hip joint prostheses shall comply with the requirements of corresponding standards.
7.2.2 The microscopic structure of forgings and processing materials shall comply with the requirements of corresponding standards.
7.2.3 The mechanical properties shall comply with the requirements of corresponding standards.
7.2.4 The internal quality of castings shall comply with the requirements of corresponding standards.
Note 1: As for hip joint prostheses made of Ti6Al4V titanium alloy forgings, ZTi6Al4V titanium alloy castings or cobalt-chromium-molybdenum alloy castings, their chemical compositions, mechanical properties, microscopic structure of forgings and internal quality of castings shall comply with the requirements of YY 0117.1~YY 0117.3.
Note 2: The samples required for inspection of the above items shall be taken from the product body. If some parts cannot be sampled on the body due to structure or dimensions, etc., they can be made on the same batch of blanks, cast-in-place samples or raw materials.
Note 3: The sample for tensile test is cut from the castings for inspection of mechanical properties, and the indicators of mechanical properties (Rm, Rp0.2, A) are determined by the supplier and the purchaser of castings through negotiation. If this requirement does not meet the corresponding requirements of YY 0117, the dynamic mechanical property test shall comply with the requirements of 8.7.
Contents of YY 0118-2016
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and designation of dimensions
5 Expected properties
6 Design attributes
7 Materials
8 Design evaluation
9 Manufacturing
10 Sterilization
11 Packaging
12 Information provided by the manufacturer
Annex A (Normative) List of standards for materials approved for the manufacture of hip joint prostheses
Annex B (Normative) List of materials approved and unapproved for the manufacture of articulating surfaces of hip joint prostheses
Annex C (Normative) List of metallic combinations approved and unapproved for non-articulating surfaces of hip joint prostheses
Annex D (Informative) List of approved standards for chemical analysis methods
