Hip Joint Prostheses

Transcription

1 Translated English of Chinese Standard: YY PHARMACEUTICAL INDUSTRY STANDARD YY ICS OF THE PEOPLE S REPUBLIC OF CHINA C 35 YY Replacing YY 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 Page 1 of 27

2 Table of Contents Foreword Scope Normative References Terms, Definitions and Classification Requirements Test Methods Inspection Rules Instructions for Use Marking Packaging 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 Page 2 of 27

3 Foreword 3.2, 4.3 and 4.4 of this Standard are recommendatory. This Standard is formulated by mainly referencing to ISO "Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 1: Classification and Designation of Dimensions", ISO "Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 2: Articulating Surfaces Made of Metallic, Ceramic and Plastics Materials" (ISO ), ISO "Non-active Surgical Implants - General Requirements", "Non-active Surgical Implants - Joint Replacement Implants - Particular Requirements", ISO "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 "Hip Joint Prostheses". Compared with YY , the main changes in this Standard are as follows: - "Definitions" in Chapter 3 adopts the definition part in ISO "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. Page 3 of 27

4 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 Sampling Procedures for Inspection by Attributes - Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection (GB/T , ISO , IDT) GB/T 2829 Sampling Procedures and Tables for Periodic Inspection by Attributes (Apply to Inspection of Process Stability) GB/T Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods GB/T Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods GB/T Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (GB/T , idt ISO : 1995) GB/T Implants for Surgery Ultra-high Molecular Weight Polyethylene - Part 2: Moulded Forms (GB/T , ISO : 1998, IDT) YY 0117 (All the parts) Implants for Surgery - Forgings, Castings for Bone Joint Prostheses Page 4 of 27

5 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 , ISO 9583: 1993, NEQ) ISO 6474 Implants for Surgery - Ceramic Materials Based on High Purity Alumina ISO Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 1: Classification and Designation of Dimensions ISO Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 2: Articulating Surfaces Made of Metallic, Ceramic and Plastics Materials ISO Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components ISO 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 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion ISO Implants for Surgery - Ceramic Materials Based on Yttria-stabilized Tetragonal Zirconia (Y-TZP) ISO Hydroxyapatite Implants for Surgery - Hydroxyapatite - Part 2: Coatings of ISO 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 Implants for Surgery - Wear of Total Hip-joint Prostheses - Part 2: Methods of Measurement ISO 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 Page 5 of 27

6 and ISO and the following ones apply Hip joint replacement Surgical implant that is used to replace one or both of the articulating surfaces of the hip joint 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 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 Acetabulum replacement Surgical implant that is consisted of an acetabulum component. It is intended to replace acetabulum articulating surface of the hip joint Femoral component Monobloc or combined component of a total-hip or partial-hip joint replacement that is intended to be attached to the femur Acetabulum component Monobloc or combined component that is intended to be fixed to biological acetabulum Bipolar head Page 6 of 27

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 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: The hydroxyapatite coating of hip joint prostheses shall meet the requirements of ISO 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 alloys shall not be used as the articulating surfaces of hip joint replacements, unless an appropriate surface treatment is undertaken and demonstrated to be suitable in clinical use. Note 2: Appendix C of this Standard provides the list of acceptable and unacceptable metallic combinations for use in non-articulating bearing surfaces of hip joint prostheses. Note 3: For applications in which two dissimilar metals or alloys, or two metals in different metallurgical states are in contact where articulation is not intended, the material combinations shall not produce unacceptable galvanic effects. 4.2 Surface quality Appearance Metal surfaces The metallic component surfaces of hip joint prostheses shall be free from defects such as scale, tool marks, nicks, scratches, cracks, cavities, sharp edges, or burrs; and shall also be free from embedded or deposited finishing materials or other contaminants Plastic surfaces The articulating surfaces of hip joint prostheses made of plastic materials shall be free from defects such as particulate contamination, chemical discolouration spots, tool marks, nicks, chips, cavities, or cracks Ceramic surfaces The articulating surfaces of hip joint prostheses made of ceramic materials shall be free from defects such as particulate contamination, chemical discolouration spots, tool marks, nicks, chips, cavities, or cracks Surface defects Page 9 of 27

8 results of test shall be recorded Endurance properties of head and neck region of stemmed femoral components The head and neck region of stemmed femoral components shall be tested in accordance with 7.2 of ISO :1992. Note: An international standard with performance requirements is being formulated. 4.4 Wear testing of total hip joint replacements The wear characteristics of total hip joint replacement implants shall be tested in accordance with a controlled, validated and documented procedure. The test implant is consisted of a femoral component with an integral head or a modular head articulating on a metallic, ceramic or UHMWPE acetabulum component. Note: ISO has started to prepare an international standard which will enable the specification of performance requirements based on the test methods given in ISO s Parts 1 and Sterilization Products supplied in sterile The products which are supplied in sterile shall be free from bacterium Implants containing UHMW polyethylene If implants are to be sterilized by ionizing radiation, the accumulated dose of radiation the implants received shall not be greater than 40 kgy Products supplied in non-sterile For products which are supplied in non-sterile, the manufacturer shall specify at least one appropriate method of sterilization. If multiple sterilizations are not allowed, this shall be stated in the product information provided by the manufacturer (see 8.2) Ethylene oxide sterilization residuals For products which are supplied by ethylene oxide sterilization, the manufacturer shall determine the acceptable limit of ethylene oxide sterilization residual that shall not be greater than those specified in GB/T Test Methods 5.1 Materials Page 12 of 27

9 g) When the national quality supervision institution proposes requirement to carry out periodic inspection Prior to periodic inspection, lot-by-lot inspection shall be carried out. Samples shall be taken from the lot that has passed lot-by-lot inspection to undergo the periodic inspection Periodic inspection shall be carried out in accordance with GB/T The rejection classification, test items and sampling scheme of periodic inspection are shown in Table 3. Table 3 Periodic Inspection Rejection classification A B Test group I II III I Test item a b In Sampling scheme 1[0, 1] 3[0, 1] All qualified upon 100% inspection In accordance with relevant standards All qualified accorda nce with relevant standard 3[0, 1] 3[0, 1] s a Products made of materials of the same lot form a material lot. b Products of the same sterilization process form a sterilization lot In principle, if the products are qualified upon periodic inspection, all test items of this period shall be qualified. 7 Instructions for Use In addition to meeting the requirements of the relevant laws and regulations, the instructions for use of hip joint prostheses shall also include the following contents: a) Name, trademark and address of the manufacturer; b) Necessary description for the user to confirm the product; c) Application scope of the product, and the requirements for safety and correct operation; d) Thorough explanation to all disposal to be made prior to use (like sterilization and final assembly, etc.); Page 15 of 27

10 c) Lot number or serial number used for accurate identification; d) Instructions for single-use product; e) Instructions for sterile package contents (e.g.: "STERILE"); f) Sterilization lot number; g) Validity of sterilization; h) Instructions for special purpose (for instance: "Custom Made" or "For Clinical Study Only"); i) Instructions for particular storage and/or delivery conditions and the relevant influence from ambient conditions; j) Warning and/or precautions; k) Sterilization method if necessary. 9 Packaging For each hip joint prosthesis, the packaging shall be designed so that, under conditions specified by the manufacturer for storage, transport and handling (including control of temperature, humidity and ambient pressure, if applicable), it protects against damage and deterioration and does not adversely affect the implant. Implants labelled with "STERILE" shall be packaged so that they remain sterile under normal storage, transport and handling conditions, unless the package which maintains sterility is damaged or opened. 10 Transportation and Storage The requirements for transportation and storage of hip joint prostheses shall comply with the relevant chapters and articles in YY Page 18 of 27

11 Appendix A (Normative) List of Material Standards Found Acceptable for the Manufacture of Hip Joint Prostheses The following materials have been found acceptable through proven use for the manufacture of hip joint prostheses. The inclusion of materials in this appendix does not imply their satisfactory use in any particular application; neither does it relieve the manufacturer from the obligation to undertake a design evaluation. ISO : 1997 Stainless Steel ISO : 1999 Titanium Implants for Surgery - Metallic Materials - Part 1: Wrought Implants for Surgery - Metallic Materials - Part 2: Unalloyed ISO : 1996 Implants for Surgery - Metallic Materials - Part 3: Wrought Titanium 6-aluminium 4-vanadium Alloy ISO : 1996 Implants for Surgery - Metallic Materials - Part 4: Cobalt-chromium-molybdenum Casting Alloy ISO : 1993 Implants for Surgery - Metallic Materials - Part 5: Wrought Cobalt-chromium-tungsten-nickel Alloy ISO : 1997 Implants for Surgery - Metallic Materials - Part 6: Wrought Cobalt-nickel-chromium-molybdenum Alloy ISO : 1994 Implants for Surgery - Metallic Materials - Part 7: Forgeable and Cold-formed Cobalt-chromium-nickel-molybdenum-iron Alloy ISO : 1997 Implants for Surgery - Metallic Materials - Part 8: Wrought Cobalt-nickel-chromium-molybdenum-tungsten-iron Alloy ISO : 1992 Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel ISO : 1994 Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-aluminium 7-niobium Alloy Page 19 of 27

12 ISO : 1996 Implants for Surgery - Metallic Materials - Part 12: Wrought Cobalt-chromium-molybdenum Alloy ISO 5833: 2002 Implants for Surgery - Acrylic Resin Cements ISO 6474: 1994 Implants for Surgery - Ceramic Materials Based on High Purity Alumina ISO 13356: 1997 Implants for Surgery - Ceramic Materials Based on Yttria-stabilized Tetragonal Zirconia (Y-TZP) ISO : 2000 Implants for Surgery - Hydroxyapatite - Part 2: Coatings of Hydroxyapatite ISO 13782: 1996 Implants for Surgery - Metallic Materials - Unalloyed Tantalum for Surgical Implant Applications GB/T Implants for Surgery - Ultra-high Molecular Weight Polyethylene - Part 1: Powder Form (ISO : 1998, IDT) GB/T Implants for Surgery - Ultra-high Molecular Weight Polyethylene -Part 2: Moulded Forms (ISO : 1998, IDT) GB Stainless Steel for Surgical Implants (ISO : 1997, MOD) GB Casting Co-Cr-Mo Alloy for Surgical Implants GB/T Wrought Titanium and Titanium Alloy for Surgical Implants YY Implants for Surgery - Acrylic Resin Cements (ISO 5833: 1992, IDT) Page 20 of 27

13 Appendix B (Normative) List of Materials Found Acceptable or not Acceptable for the Manufacture of Articulating Surfaces of Hip Joint Prostheses B.1 Suitable material combinations For the articulating surfaces of hip joint replacement implants, the following combinations of the materials listed in Appendix A have been found to be acceptable in particular applications, provided that adequate attention is paid to in design, surface finish and surface treatment: a) Wrought stainless steel (ISO ) / UHMWPE (ISO , ISO ); b) Wrought high nitrogen stainless steel (ISO ) / UHMWPE (ISO , ISO ); c) Cobalt-chromium-molybdenum casting alloy (ISO , GB 17100) / UHMWPE (ISO , ISO ); d) Wrought cobalt-chromium tungsten-nickel alloy (ISO ) / UHMWPE (ISO , ISO ); e) Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO ) / UHMWPE (ISO , ISO ); f) Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy (ISO ) / UHMWPE (ISO , ISO ); g) Wrought titanium 6-aluminium 4-vanadium alloy 1) (ISO ) / UHMWPE (ISO , ISO ); h) Wrought titanium 6-aluminium 7-niobium alloy 1) (ISO ) / UHMWPE (ISO , ISO ); i) Ceramic materials based on alumina (ISO 6474) / UHMWPE (ISO , ISO ); j) Ceramic materials based on zirconia (ISO 13356) / UHMWPE (ISO , ISO ); 1) Particular attention to surface treatment of the articulating surface may be necessary. Page 21 of 27

14 Appendix C (Normative) List of Materials Found Acceptable or Non-acceptable for Metallic Combinations for Non-articulating Contacting Surfaces of Hip Joint Prostheses C.1 Suitable combinations of dissimilar metals for non-articulating contacting surfaces For some applications where one metal or alloy is in contact with another and articulation is not intended, the following metallic combinations involving the metals listed in Appendix A have been found to be acceptable and can be used, provided that the adequate attention is paid to in design, surface finish, surface treatment, and metallurgical conditions: a) Cobalt based alloys (ISO , ISO , ISO , ISO , ISO 58328, ISO ) / titanium based alloys (ISO 58323, ISO , ISO ); b) Cobalt based alloys (ISO , ISO , ISO , ISO , ISO , ISO ) / other cobalt based alloys (ISO , ISO , ISO , ISO , ISO , ISO ); c) Stainless steel (ISO , ISO ) / titanium based alloys (ISO , ISO , ISO ); d) Stainless steel (ISO , ISO ) / stainless steel (ISO , ISO ); e) Stainless steel (ISO ) / cobalt based alloys (ISO , ISO , ISO , ISO , ISO , ISO ). C.2 Non-acceptable metallic combinations for non-articulating contacting surfaces For some applications where one metal or alloy is in contact with another and articulation is not intended, the following combinations of the metals listed in Appendix A have been found not acceptable: a) Stainless steel (excluding the material described in ISO ) / cobalt based alloys (ISO , ISO , ISO , ISO , ISO , Page 24 of 27

15 Bibliography [1] ISO 6018 Orthopaedic implants - General requirements for marking, packaging and labelling [2] ISO Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components [3] ISO Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 6: Endurance Properties Testing and Performance Requirements of Neck Region of Stemmed Femoral Components [4] ISO Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion [5] ISO Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 9: Determination of Resistance to Torque of Head Fixation of Stemmed Femoral Components [6] ISO 8828 Implants for Surgery - Guidance on Care and Handling of Orthopaedic Implants [7] ISO/TR 9325 Implants for Surgery - Partial and Total Hip Joint Prostheses - Recommendations for Simulators for Evaluation of Hip Joint Prostheses [8] ISO/TR 9326 Implants for Surgery - Partial and Total Hip Joint Prostheses - Guidance for Laboratory Evaluation of Change of Form of Bearing Surfaces [9] GB/T Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (GB/T , idt ISO : 1995) [10] ISO 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 [11] ISO Implants for Surgery - Wear of Total Hip-joint Prostheses - Part 2: Methods of Measurement [12] ISO : 2000 Implants for Surgery - Hydroxyapatite - Part 1: Ceramic Hydroxyapatite [13] ISO : 2000 Implants for Surgery - Hydroxyapatite - Part 2: Coatings of Hydroxyapatite Page 26 of 27