YY 0502-2016 in English

1 Scope

This standard specifies the terms and definitions and requirements for classification and designation of dimensions, expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer of knee joint prostheses.

This standard is applicable to partial and total knee joint prostheses made of materials and by techniques specified in this standard.

2 Normative references

The following documents for the application of this document are essential. Any dated reference, just dated edition applies to this document. For undated references, the latest edition of the normative 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 0810.1 Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
YY/T 0811 Standard guide for extensively irradiation - Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
YY/T 0919 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
YY/T 0924.1 Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
YY/T 0924.2 Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials
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 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zireonia (Y-TZP)
ISO 14630 Non-active surgical implants - General requirements
ISO 14243-1 Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
ISO 14243-2 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
ISO 14243-3 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
ISO 21534 Non-active surgical implants - Joint replacement implants - Particular requirements
ASTM F1044 Standard test method for shear testing of calcium phosphate coatings and metallic coatings
ASTM F1147 Standard test method for tension testing of calcium phosphate and metallic coatings
ASTM F1160 Standard test method for shear and bending fatigue testing of calcium phosphate and metallic medical and composite calcium phosphate/metallic coatings
ASTM F1377 Standard specification for cobalt-28 chromium-6 molybdenum power for coating of orthopedic implants (UNS-R30075)
ASTM F1580 Standard specification for titanium and titanium-6 aluminum-4 vanadium alloy powders for coatings of surgical implants
ASTM F1854 Standard test method for stereological evaluation of porous coatings on medical implants
ASTM Fl978 Standard test method for measuring abrasion resistance of metallic thermal spray coatings by using the taber abraser

3 Terms and definitions

For the purpose of this document, the terms and definitions given in YY/T 0919, YY/T 0924.1 and ISO 21534 and the following apply.

3.1
conventional UHMWPE
UHMWPE manufacture by compression or extrusion molding and not crosslinked prior to final sterilization

3.2
extensively radiation-cross-linked UHMWPE
UHMWPE manufactured by compression or extrusion molding and subjected to the irradiation from gamma rays or electron beam at a dose higher than 40 kGy for improving wear resistance

Foreword I
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and designation of dimensions
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Manufacture
10 Sterilization
11 Packaging
12 Information supplied by the manufacturer
Annex A (Normative) List of standards for materials found acceptable for the manufacture of knee joint prostheses
Annex B (Normative) List of materials found acceptable or not acceptable for the manufacture of articulating surfaces of knee joint prostheses
Annex C (Normative) List of materials found acceptable or non-acceptable for metallic combinations for use for non-articulating contacting surfaces of knee joint prostheses
Annex D (Normative) List of standards for approved method for chemical analysis