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YY 0502-2005

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标准号码内文价格(元)第2步交付天数标准名称状态
YY 0502-2005 英文版 590 购买 现货,9秒内自动发货PDF,有增值税发票。 膝关节假体 作废

   
标准编号: YY 0502-2005 (YY0502-2005)
中文名称: 膝关节假体
英文名称: Knee joint prostheses
行业: 医药行业标准
中标分类: C35
国际标准分类: 11.040.40
字数估计: 22,270
发布日期: 2005-12-07
实施日期: 2006-12-01
引用标准: 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; I
采用标准: ISO 14630-1997, NEQ; ISO 21534-2002, NEQ; ISO 21536-2002, NEQ; ISO 7207-1-1994, NEQ; ISO/FDIS 7207-2-1998, NE
起草单位: 北京百慕航材高科技股份公司
归口单位: 全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)
标准依据: 行标公告 2006年第2号(总第74号);国家食品药品监督管理总局公告2016年第25号
提出机构: 国家食品药品监督管理局
发布机构: 国家食品药品监督管理局
范围: 本标准规定了膝关节假体的定义、分类、预期性能、要求、试验方法、检验规则、标记、使用说明书、包装、运输和贮存等要求。本标准适用于对人体施行部分或全膝关节置换的无源外科植入物。


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 -
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
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 -
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
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
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
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
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
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.
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).
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
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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