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YY 0118-2005 English PDF (YY0118-2005)

YY 0118-2005 English PDF (YY0118-2005)

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YY 0118-2005: Hip joint prostheses

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.
YY 0118-2005
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0118-1993
Hip Joint Prostheses
???????????????
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, constitute provisions of this Standard. For dated reference, the subsequent 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 (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, 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 Prostheses
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 ISO 7206-4 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 4. 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 Tetragonal Zirconia (Y-TZP)
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 Terms, Definitions and Classification
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
Surgical implant that is consisted of a femoral component and an acetabulum 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 replace acetabulum articulating surface of the hip joint.
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
Bipolar head
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 non-acceptable for manufacturing the articulating surfaces of hip joint prostheses; unalloyed titanium and titanium all...

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