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YY 0118-2005

标准搜索结果: 'YY 0118-2005'
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YY 0118-2005 英文版 355 购买 现货,9秒内自动发货PDF,有增值税发票。 髋关节假体 作废

   
标准详细信息 YY 0118-2005; YY0118-2005
中文名称: 髋关节假体
英文名称: Hip 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: 16,000
发布日期: 2005-12-07
实施日期: 2006-12-01
旧标准 (被替代): YY 0118-1993
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; YY 0117.1; YY 0117.2; YY 0117.3; YY 0341; YY/T 0343; ISO 6476; ISO 7206-1; ISO 7206-2; ISO 7206-4; ISO 7206-6; ISO 7206-8; ISO 13356; ISO 13779-2; ISO 14242-1; ISO 14242-2; IS
采用标准: ISO 7206-1, NEQ; ISO 7206-2, NEQ; ISO 14630, NEQ; ISO 21534, NEQ; ISO 21535, NEQ
起草单位: 北京百慕航材高科技股份有限公司
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: 本标准规定了全髋和部分髋关节假体的定义、分类、要求、试验方法、检验规则、标记、包装、使用说明书、运输和贮存等。本标准适用于对人体进行全髋和部分髋关节置换的关节假体。


YY 0118-2005
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0118-1993
Hip Joint Prostheses
髋关节假体
ISSUED ON. DECEMBER 7, 2005
IMPLEMENTED ON. DECEMBER 1, 2006
Issued by. China State Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative References ... 4 
3 Terms, Definitions and Classification ... 5 
4 Requirements ... 8 
5 Test Methods ... 12 
6 Inspection Rules ... 14 
7 Instructions for Use ... 15 
8 Marking ... 16 
9 Packaging ... 18 
10 Transportation and Storage ... 18 
Appendix A (Normative) List of Material Standards Found Acceptable
for the Manufacture of Hip Joint Prostheses ... 19 
Appendix B (Normative) List of Materials Found Acceptable or not
Acceptable for the Manufacture of Articulating Surfaces of Hip Joint
Prostheses ... 21 
Appendix C (Normative) List of Materials Found Acceptable or
Non-acceptable for Metallic Combinations for Non-articulating
Contacting Surfaces of Hip Joint Prostheses ... 24 
Bibliography ... 26 
Foreword
3.2, 4.3 and 4.4 of this Standard are recommendatory.
This Standard is formulated by mainly referencing to ISO 7206-1 "Implants for Surgery
- Partial and Total Hip Joint Prostheses - Part 1. Classification and Designation of
Dimensions", ISO 7206-2 "Implants for Surgery - Partial and Total Hip Joint
Prostheses - Part 2. Articulating Surfaces Made of Metallic, Ceramic and Plastics
Materials" (ISO 7206-2), ISO 21534 "Non-active Surgical Implants - General
Requirements", "Non-active Surgical Implants - Joint Replacement Implants -
Particular Requirements", ISO 21535 "Non-active Surgical Implants - Joint
Replacement Implants - Specific Requirements for Hip-joint Replacement Implants",
YY/T 0340 "Implants for Surgery - Fundamental Principles", and YY 0341 "General
Technological Requirements for Non-active Metallic Surgery Implants of
Osteosynthesis".
This Standard shall replace YY 0118-1993 "Hip Joint Prostheses". Compared with YY
0118-1993, the main changes in this Standard are as follows.
- "Definitions" in Chapter 3 adopts the definition part in ISO 21535 "Non-active
Surgical Implants - Joint Replacement Implants - Specific Requirements for
Hip-joint Replacement Implants";
- The technical contents have referenced the content requirements of the latest
international standards, national standards, and industry standards; and the
various technical contents are re-compiled.
Appendixes A, B and C of this Standard are normative.
This Standard was proposed by the China State Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee on
Implants for Surgery and Orthopaedic Devices of Standardization Administration of
China (SAC/TC 110).
Drafting organization of this Standard. Baimtec Material Co., Ltd.
Chief drafting staffs of this Standard. Tian Bin, Shen Sihong, and Qiao Zhen.
Hip Joint Prostheses
1 Scope
This Standard specifies the definitions, classification, requirements, test methods,
inspection rules, marking, packaging, instructions for use, transportation, storage etc.
of total-hip and partial-hip joint replacements.
This Standard is applicable to the joint prostheses used for the total-hip and partial-hip
joint replacement of human body.
2 Normative References
The following standards contain provisions which, through reference in this text,
amendments (excluding corrections) or revisions of these publications do not apply.
However, the parties who enter into agreements based on this Standard are
encouraged to investigate the possibility of applying the most recent editions of the
standards. For undated references, the latest edition of the normative document
referred to 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, IDT)
GB/T 2829 Sampling Procedures and Tables for Periodic Inspection by Attributes
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, idt ISO 10993-7. 1995)
GB/T 19701.2 Implants for Surgery Ultra-high Molecular Weight Polyethylene -
Part 2. Moulded Forms (GB/T 19701.2-2005, ISO 5834-2. 1998, IDT)
YY 0117 (All the parts) Implants for Surgery - Forgings, Castings for Bone Joint
YY 0341 General Technological Requirements for Non-active Metallic Surgery
Implants of Osteosynthesis
YY/T 0343 Liquid Penetrant Inspection of Metallic Surgical Implants (YY/T
0343-2002, ISO 9583. 1993, NEQ)
ISO 6474 Implants for Surgery - Ceramic Materials Based on High Purity Alumina
ISO 7206-1 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 1.
Classification and Designation of Dimensions
ISO 7206-2 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part
2. Articulating Surfaces Made of Metallic, Ceramic and Plastics Materials
Determination of Endurance Properties and Performance of Stemmed Femoral
Components
ISO 7206-6 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 6.
Endurance Properties Testing and Performance Requirements of Neck Region of
Stemmed Femoral Components
ISO 7206-8 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 8.
Endurance Performance of Stemmed Femoral Components with Application of
Torsion
ISO 13356 Implants for Surgery - Ceramic Materials Based on Yttria-stabilized
ISO 13779-2 Implants for Surgery - Hydroxyapatite - Part 2. Coatings of
Hydroxyapatite
ISO 14242-1 Implants for Surgery - Wear of Total Hip-joint Prostheses - Part 1.
Loading and Displacement Parameters for Wear-testing Machines and
Corresponding Environmental Conditions for Test
ISO 14242-2 Implants for Surgery - Wear of Total Hip-joint Prostheses - Part 2.
Methods of Measurement
ISO 21534 Non-active Surgical Implants - Joint Replacement Implants -
Particular Requirements
3.1 Terms and definitions
For the purposes of this Standard, the terms and definitions established in ISO 21534
and ISO 7206-1 and the following ones apply.
3.1.1
Hip joint replacement
Surgical implant that is used to replace one or both of the articulating surfaces of the
hip joint.
3.1.2
Total hip joint replacement
component. It is intended to replace both of the articulating surfaces of the hip joints.
3.1.3
Partial hip joint replacement
Surgical implant that is consisted of a femoral component. It is intended to replace the
femoral articulating surface of the hip joint.
Note. partial hip joint replacement implants incorporate either a bipolar or a unipolar head.
3.1.4
Acetabulum replacement
Surgical implant that is consisted of an acetabulum component. It is intended to
3.1.5
Femoral component
Monobloc or combined component of a total-hip or partial-hip joint replacement that is
intended to be attached to the femur.
3.1.6
Acetabulum component
Monobloc or combined component that is intended to be fixed to biological
acetabulum.
3.1.7
4.1.3 The physical properties of the ultra-high-molecular-weight polyethylene
materials used for manufacturing hip joint prostheses shall meet the requirements of
Table 1 in GB/T 19701.2-2005.
4.1.4 The physical and chemical properties of ceramic materials used for
manufacturing hip joint prostheses shall meet the requirements of ISO 6474. 1994 or
the requirements of Table 1 in ISO 13356. 1997.
4.1.5 The hydroxyapatite coating of hip joint prostheses shall meet the requirements
of ISO 13779-2.
Note 1. Appendix B of this Standard provides the list of materials found acceptable or
titanium and titanium all...
   
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