1 Scope
This standard specifies the definitions, classification, requirements, test methods, inspection rules, marking, packaging, instructions for use, transportation, storage and the like of total and partial hip joint replacements.
This standard is applicable to the joint prostheses used for the total 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, subsequent amendments to (excluding corrections to), or revisions of, any of these publications do not apply. However, the parties to 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 Equipments 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
Implant used to replace one or both of the articulating surfaces of the hip joint.
3.1.2
Total hip joint replacement
Implant comprising a femoral component and an acetabulum component intended to replace both of the articulating surfaces of the hip joints.
3.1.3
Partial hip joint replacement
Implant comprising a femoral component 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
Implant comprising an acetabulum component intended to replace acetabulum articulating surface of the hip joint.
3.1.5
Femoral component
Part of a total or partial hip joint replacement which is intended to be attached to the femur.
3.1.6
Acetabulum component
Implant of monobloc or modular construction intended to be fixed to the prepared biological acetabulum.
3.1.7
Bipolar head
Part of a femoral component with a concave (inner) surface intended to articulate with the spherical head of the femoral component and a convex (outer) spherical surface intended to articulate with the biological acetabulum.
3.1.8
Unipolar head
Head of a femoral component intended to articulate with the biological acetabulum.
3.1.9
Module component
Femoral or acetabulum component which is assembled by the user from a number of sub-components.
3.1.10
Monobloc component
Femoral or acetabulum component which is supplied as a single unit.
3.2 Classification
3.2.1 Product classification
The classification of hip joint prostheses according to product use and form is detailed in Table 1.
Foreword II
1 Scope
2 Normative References
3 Terms, Definitions and Classification
4 Requirements
5 Test Methods
6 Inspection Rules
7 Instructions for Use
8 Marking
9 Packaging
10 Transportation and Storage
Appendix A (Normative) List of Material Standards Found Acceptable for the Manufacture of Hip Joint Prostheses
Appendix B (Normative) List of Materials Found Acceptable or not Acceptable for the Manufacture of Articulating Surfaces of Hip Joint Prostheses
Appendix C (Normative) List of Materials Found Acceptable or Non-acceptable for Metallic Combinations for Non-articulating Contacting Surfaces of Hip Joint Prostheses
Bibliography
