YY 0502-2016_English: PDF (YY0502-2016)
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Standard ID | YY 0502-2016 (YY0502-2016) | Description (Translated English) | Joint replacement implants. Knee joint prostheses | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C35 | Classification of International Standard | 11.040.40 | Word Count Estimation | 14,181 | Date of Issue | 1/26/2016 | Date of Implementation | 2018-01-01 | Older Standard (superseded by this standard) | YY 0502-2005 | Quoted Standard | GB/T 10610; GB/T 14233.1; GB/T 14233.2; GB/T 16886.7; GB 18278; GB 18279; GB 18280; GB/T 19701.1; GB/T 19701.2; GB 23101.2; YY 0117.1; YY 0117.2; YY 0117.3; YY/T 0343; YY/T 0772.3; YY/T 0772.4; YY/T 0772.5; YY/T 0810.1; YY/T 0919; YY/T 0924.1; YY/T 0924.2; ISO 6474-1; ISO 6474 | Drafting Organization | Tianjin Medical Device Quality Supervision and Inspection Center, Shi Lehui Surgical Implants (Beijing) Co., Ltd., Beijing 100 Screen Aviation Materials High Technology Co., Ltd. | Administrative Organization | National Technical Committee on Orthopedic Implants for Orthopedic Implants and Orthopedic Devices Technical Committee (SAC/TC 110/SC 1) | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies the terms and definitions, classification and dimensioning, expected properties, design properties, materials, design evaluation, manufacturing, sterilization, packaging, and information requirements of the manufacturer of knee prostheses. This standard applies to partial and total knee prostheses made using the materials and processes specified in this standard. | Standard ID | YY 0502-2005 (YY0502-2005) | Description (Translated English) | Knee joint prostheses | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C35 | Classification of International Standard | 11.040.40 | Word Count Estimation | 22,238 | Date of Issue | 2005-12-07 | Date of Implementation | 2006-12-01 | Quoted Standard | GB/T 2828.1; GB/T 2829; GB/T 14233.1; GB/T 14233.2; GB/T 16886.7; GB/T 19701.2; GB/T 19633; YY 0117-2005; YY 0341; YY 0343; HB/Z 60; ISO 7207-1; ISO 7207-2; ISO 13779-3 | Adopted Standard | ISO 14630-1997, NEQ; ISO 21534-2002, NEQ; ISO 21536-2002, NEQ; ISO 7207-1-1994, NEQ; ISO/FDIS 7207-2-1998, NE | Drafting Organization | Beijing Air Materiel Bermuda tech stock company | Administrative Organization | National standardization technical committee of Surgical characters and orthopedic implant device | Regulation (derived from) | Industry Standard Notice 2006 No. 2 (No. 74 overall) | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies the knee prosthesis definition, classification, expected performance, requirements, test methods, inspection rules, marking, manual, packaging, transportation and storage requirements. This standard applies to the human body part or all of the purposes of the passive knee replacement surgical implants. |
YY 0502-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0502-2005
Joint Replacement Implants – Knee Joint Prostheses
关节置换植入物 膝关节假体
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3
1 Scope .. 4
2 Normative References . 4
3 Terms and Definitions . 7
4 Classification and Dimension Marking . 7
5 Expected Performance . 7
6 Design Attributes .. 7
7 Materials . 7
8 Design Evaluation . 10
9 Manufacture . 12
10 Sterilization . 12
11 Package . 13
12 Information Provided by the Manufacturer .. 13
Appendix A (Normative) Approved Material Standard List on Manufacturing the
Knee Joint Prostheses . 14
Appendix B (Normative) Approved and Non-Approved Material List on
Manufacturing Articular Surface of Knee Joint Prostheses .. 16
Appendix C (Normative) Approved and Non-Approved Metal Combination List
on Non-Articular Contact Surface of Knee Joint Prostheses . 18
Appendix D (Normative) Approved Standard List for Chemical Analysis Method
. 19
Joint Replacement Implants – Knee Joint Prostheses
1 Scope
This Standard specifies the requirements for terms and definitions, classification and
dimension marking, expected performance, design attributes, materials, design
evaluation, manufacture, sterilization, package, and information provided by the
manufacturer of the knee joint prostheses.
This Standard is applicable to partial or total knee joint prostheses manufactured by
the materials and processes specified in this Standard.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
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 Equipment 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 - Requirement 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 Form
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-Cross-linked 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, Definition and Designation of Dimensions
YY/T 0924.2 Implants for Surgery – Components for Partial and Total Knee Joint
Prostheses – Part 2. Articulating Surface Made of Metal, Ceramic and Plastic
Materials
ISO 6474-1 Implants for Surgery – Ceramic Materials – Part 1. Ceramic Materials
Based on High Purity Alumina
7.2 Metallic materials
7.2.1 The chemical composition of the metallic materials used for manufacturing the
knee joint prostheses shall conform to the provisions of corresponding standard.
7.2.2 The microstructure of the forgings shall conform to the provisions of
corresponding standard.
7.2.3 The mechanical properties shall conform to the provisions of corresponding
standard.
7.2.4 The internal quality of the castings shall conform to the provisions of
corresponding standard.
NOTE. when the material of knee joint prostheses adopts Ti6Al4V titanium alloy forgings,
ZTi6Al4V titanium alloy castings, cobalt chromium molybdenum alloy castings, its chemical
compositions, mechanical properties, the microstructure of the forgings, the internal quality of
the castings shall conform to the provisions of YY0117.1~0117.3.
7.3 UHMWPE material
7.3.1 The physical properties of conventional UHMWPE material used for
manufacturing the knee joint prostheses shall conform to the provisions of GB/T
19701.2; the content of impurity elements shall conform to the provisions of
GB/T19701.1. The manufacturers shall evaluate the oxidative stability (e.g.. oxidation
index and mechanical properties before and after aging) and morphology of the
conventional UHMWPE material according to the method given in YY/T 0772.3~YY
0772.5.
7.3.2 The manufacturer shall specify the performance index of extensively radiation-
cross-linked UHMWPE material according to the requirements of YY/T 0811.
7.4 Ceramic material
The physical and chemical properties of ceramic material used for manufacturing knee
joint prostheses shall conform to the provisions of ISO 6474-1, ISO 6474-2 or ISO
13356.
7.5 Coating material
7.5.1 Hydroxyapatite coating
The hydroxyapatite coating for knee joint prostheses shall conform to the provisions of
GB 23101.2.
7.5.2 Plasma sprayed metallic coating
8 Design Evaluation
8.1 General
The requirements of YY/T 0919 and the following contents are applicable to this
Standard.
8.2 Appearance
8.2.1 Metallic surface
When visually examining with normal or corrected vision, the metal part surface of
knee joint prostheses shall be free of oxide scales, knife marks, small gaps, scratches,
cracks, depressions, traps, sharp edges, burrs, and other defects; the surface shall
also be free of inlays, final processed deposits and other contaminants.
NOTE. for the metal parts with coatings, the manufacturer shall specify the requirements of
coating surface quality.
8.2.2 Plastic surface
When visually examining with normal or corrected vision, the articular surface of the
plastic parts of the knee joint prostheses shall be free from particulate contamination.
8.2.3 Ceramic surface
When visually examining with normal or corrected vision, the articular surface of the
ceramic parts of knee joint prostheses shall be free of particulate contamination, spot-
like or larger chemical color change, knife marks, small gaps, debris, depressions,
cracks and the like defects.
8.3 Surface defects
When testing as per the test method given in YY/T 0343, the surface of the uncoated
metal parts and the surface of ceramic parts shall be free of discontinuous defects.
NOTE. for the metal parts with coatings, the manufacturer shall perform surface defect
inspection of the product before coating.
8.4 Surface roughness
8.4.1 The articular surface roughness Ra value of partial or full knee joint prostheses
metal or ceramic femoral components shall be no greater than 0.1µm.
8.4.2 The articular surface roughness Ra value of particular or full knee joint
prostheses plastic tibial and patellar components shall be no greater than 2µm.
NOTE. The tibial tray test method in YY/T 0810.1 is a simplified method to evaluate the
performance and modelling part rather than all clinical failure modes. Minimum performance
level of 900N is determined as per the literature and t he experience of several test institutes.
Some researchers have used other test methods to evaluate similar or different failure modes
of the full knee joint tibial components; their practice is also recognized.
8.6.3 Wear test for full knee replacement (recommended)
The wear characteristics of full knee replacement consisting of metal or ceramic
femoral components or tibial components shall be tested as per ISO 14243-1, ISO
14243-2 and ISO 14243-3.
8.7 Relative angular motion range
The relative angular motion range between femoral component and tibial component
shall be tested as per the provisions of ISO 21534; YY/T 0919 gives an applicable
method for measuring the range of motion of a fully constrained knee joint.
9 Manufacture
It shall meet the requirements of YY/T 0919.
10 Sterilization
10.1 General
The requirements of YY/T 0919 and the following contents are applicable to this
Standard.
10.2 Products supplied in sterilized state
For the products supplied in sterilized state, the sterilization process shall be effective
and routinely controlled.
NOTE. GB/T 14233.2 specifies a sterility test method; but this method can’t prove the
effectiv...
......
YY 0502-2005
YY
ICS 11.040.40
C 35
Pharmaceutical Industry Standard
of the People’s Republic of China
Knee Joint Prostheses
膝关节假体
ISSUED ON. DECEMBER 7, 2005
IMPLEMENTED ON. DECEMBER 1, 2006
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Classification, dimensions and schematic diagrams ... 9
5 Intended performance ... 16
6 Requirements ... 17
7 Test methods ... 20
8 Inspection rules ... 21
9 Packaging ... 23
10 Information provided by the manufacturer ... 23
11 Transportation and storage ... 26
Annex A ... 27
Annex B ... 29
Annex C ... 31
Bibliography ... 33
Foreword
This Standard was prepared by reference to relevant contents of international
standards ISO 14630.1997 "Non-active Surgical Implants - General Requirements",
ISO 21534.2002 "Non-active Surgical Implants - Joint Replacement Implants -
Particular Requirements", ISO 21536.2002 "Non-active Surgical Implants - Joint
Replacement Implants - Specific Requirements for Knee-Joint Replacement Implants",
ISO 7207-1.1994 "Implants for Surgery - Femoral and Tibial Components for Partial
and Total Knee Joint Prostheses", and ISO /FDIS 7207-2.1998 "Implants for Surgery -
Femoral and Tibial Components for Partial and Total Knee Joint Prostheses - Part 2.
Articulating Surfaces Made of Metal, Ceramic and Plastics Materials".
This Standard was proposed by the China Food and Drug Administration.
This Standard shall be under the jurisdiction of the National Technical Committee on
Implants for Surgery and Orthopaedic Devices of Standardization Administration of
China (SAC/TC 110).
Drafting organization of this Standard. Beijing Baimtec Material Co., Ltd.
Main drafters of this Standard. Huang Yongling, Sun Jianwen, and Cui Jian.
Knee Joint Prostheses
1 Scope
This Standard specifies the definitions, classification, intended performance,
requirements, test methods, inspection rules, marking, instructions for use, packaging,
transportation, and storage of knee joint prostheses.
This Standard is applicable to non-active surgical implants that replace partial or full
knee joint of human body.
2 Normative references
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrections) or revisions do not apply to this Standard, however, parties
who reach an agreement based on this Standard are encouraged to study if the latest
versions of these documents are applicable. For undated references, the latest edition
of the referenced document applies.
GB/T 2828.1 Sampling Procedures for Inspection by Attributes - Part 1. Sampling
Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection
(GB/T 2828.1-2003, ISO 2859-1.1999, IDT)
GB/T 2829 Sampling Procedures and Tables for Periodic Inspection by Attributes
(Apply to Inspection of Process Stability)
GB/T 14233.1 Test Methods for Infusion, Transfusion, Injection Equipment 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/T 16886.7-2001, ISO 10993-7.1995, IDT)
GB/T 19701.2 Implants for Surgery - Ultrahigh Molecular Weight Polyethylene -
Part 2. Moulded Forms (ISO 5834-2, IDT)
GB/T 19633 Packaging for Terminally Sterilized Medical Devices (GB/T
19633-2005, ISO 11607.2003, IDT)
YY 0117-2005 (all the parts) Implants for Surgery - Forgings, Castings for Bone
Joint Prostheses
YY 0341 General Technological Requirements for Non-active Metallic Surgery
Implants of Osteosynthesis
YY 0343 Liquid Penetrant Inspection of Metallic Surgical Implants (ISO 9583,
NEQ)
HB/Z 60 Instructions for X-ray Examination
ISO 7207-1 Implants for Surgery - Femoral and Tibial Components for Partial and
Total Knee Joint Prostheses - Part 1. Classification, Definitions and Designation of
Dimensions
ISO 7207-2 Implants for Surgery - Femoral and Tibial Components for Partial and
Total Knee Joint Prostheses - Part 2. Articulating Surfaces Made of Metal, Ceramic
and Plastics Materials
ISO 13779-2 Implants for Surgery - Hydroxyapatite - Part 2. Coatings of
Hydroxyapatite
ISO 14630 Non-active Surgical Implants - General Requirements
ISO 21534 Non-active Surgical Implants - Joint Replacement Implants -
Particular Requirements
ISO 21536 Non-active Surgical Implants - Joint Replacement Implants - Specific
Requirements for Knee-Joint Replacement Implants
ISO 6474 Implants for Surgery - Ceramic Materials Based on High Purity Alumina
ISO 13356 Implants for Surgery - Ceramic Materials Based on Yttria-stabilized
Tetragonal Zirconia
3 Terms and definitions
The following terms and definitions apply to this Standard.
3.1
Unicompartmental knee joint prostheses
Knee joint prostheses that is designed to replace the femoral and tibial bearing
surfaces in one compartment of the knee.
3.2
Partial unicompartmental knee joint component
Knee joint prostheses that is designed to replace the bearing surface of one condyle
OF either the femur or the tibia (See Figure 1, position A, B, C or D).
3.3
Partial bicompartmental knee joint component
Knee joint prostheses that is designed to replace the bearing surfaces of both
condyles OF either the femur or the tibia (See Figure 1, positions A and B, or C and
D).
Note 1. In surgical practice, unicondylar components can be used either for unicondylar
replacements, for partial replacements, or for total replacements; whereas generally
bicondylar components are used only for total knee joint replacement.
3.4
Unicompartmental knee joint replacement
Procedure of replacing the bearing surfaces of the contiguous condyles of the femur
and tibia in one compartment of the knee (See Figure 1, positions A and C, or B and
D).
3.5
Total replacement of the knee joint
Procedure of replacing the femoral and tibial bearing surfaces in both compartments
of the knee (See Figure 1, positions A, B, C and D).
Note 2. Patella attachment device may or may not be provided.
3.6
Non-constrained total knee joint prostheses
Total knee joint prostheses in which there is no mechanical attachment between the
tibial and femoral components, and which allows movement in all three planes (see
figures 2, 3, and 4).
3.7
Partially-constrained total knee joint prostheses
Total knee joint prostheses that have some mechanical constraint between the tibial
and femoral components, and which allows movement in more than one plane (see
Figure 5).
3.8
Fully-constrained total knee joint prostheses
Total knee joint prostheses in which the two parts are mechanically articulated and
which allows movement principally in one plane (see Figure 6).
3.9
Effective bone resection distance
Minimum distance between resected surfaces of the femur and/or tibia in contact with
the plateau of the implant.
3.10
Stem
The part of bicondylar component that enters into the medullary cavity (see figures 2,
5, and 6, dimensions t and f).
3.11
Femoral stem angle
Acute angle BETWEEN the axis of the femoral stem AND the normal of installation
plateau, as viewed from the front-back direction.
Note 3. The direction of this angle determines whether the prostheses is used in the right or
left leg of the patient.
3.12
Tibial stem angle
Angle BETWEEN the axis of the tibial stem AND the normal of installation plateau, as
viewed from the front-back direction.
3.13
Intracondylar projection
The part that is used to position and fix the condylar component in the condyle (see
Figures 3 and 4, dimensions tp and fp).
3.14
Overall width
The maximum dimension between two planes (see figures 2 to 5, dimension w).
3.15
Tibial tray
The sub-component that is used to support and secure the articulating
sub-component of a tibial component of a unicompartmental or total knee joint
prostheses.
3.23
Patella component
Component of a total or partial knee joint replacement which is used to replace the
articulating surface of the patella.
3.24
Patella tray
The sub-component that is used to support and secure the articulating
sub-component of a patella component.
3.25
Meniscal component
The component ...
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