YY 0502-2005_English: PDF (YY0502-2005)
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Joint replacement implants - Knee joint prostheses
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Knee joint prostheses
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Preview PDF: YY 0502-2016 Standards related to: YY 0502-2005
| 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 0502-2005
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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