YY 0118-2016_English: PDF (YY0118-2016)
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Joint replacement implants - Hip joint prostheses
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Hip joint prostheses
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| Standard ID | YY 0118-2016 (YY0118-2016) | | Description (Translated English) | Joint replacement implants. Hip joint prostheses | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 15,199 | | Date of Issue | 1/26/2016 | | Date of Implementation | 2018-01-01 | | Older Standard (superseded by this standard) | YY 0118-2005 | | Quoted Standard | GB/T 10610; GB/T 14233.1; GB/T 14233.2; GB/T 16886.7; GB 18278; GB 18279; GB 18280; GB/T 19701.1; GB/T 19701.2; GB 23101.2; YY 0117.1; YY 0177.2; YY 0177.3; YY/T 0343; YY/T 0772.3; YY/T 0772.4; YY/T 0772.5; YY/T 0809.1; YY/T 0809.2; YY/T 0811; YY/T 0920; ISO 4287; ISO 6474-1 | | Drafting Organization | (Beijing) Co., Ltd., the State Food and Drug Administration Medical Device Technology Review Center (Beijing) Co., Ltd., Beijing Medical Device Quality Supervision and Inspection Center, Beijing 100 Screen Aviation Materials High-tech Co., Ltd., Shi Lehui Surgical Implants | | Administrative Organization | National Technical Committee on Orthopedic Implants for Orthopedic Implants and Orthopedic Devices Technical Committee (SAC/TC 110/SC 1) | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the terms and definitions of partial and total hip prostheses, the requirements for classification and dimensioning, expected performance, design properties, materials, design evaluation, manufacture, sterilization, packaging and information provided by the manufacturer. This standard applies to partial and total hip prostheses made using the materials and processes specified in this standard. | | Standard ID | YY 0118-2005 (YY0118-2005) | | Description (Translated English) | Hip joint prostheses | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 16,133 | | Date of Issue | 2005-12-07 | | Date of Implementation | 2006-12-01 | | Older Standard (superseded by this standard) | YY 0118-1993 | | Quoted Standard | 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 | | Adopted Standard | ISO 7206-1, NEQ; ISO 7206-2, NEQ; ISO 14630, NEQ; ISO 21534, NEQ; ISO 21535, NEQ | | Drafting Organization | Beijing Air Materiel Bermuda -tech Co., Ltd. | | Administrative Organization | National standardization technical committee of Surgical characters and orthopedic implant device | | Regulation (derived from) | Industry Standard Notice 2006 No. 2 (No. 74 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the total hip and partial hip prosthesis definition, classification, requirements, test methods, inspection rules, marking, packaging, manual, transport and storage. This standard applies to the human body for full and partial hip replacement hip joint prosthesis. | | Standard ID | YY 0118-1993 (YY0118-1993) | | Description (Translated English) | (Hip prosthesis) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 16,11 | | Date of Issue | 1993/7/19 | | Date of Implementation | 1993/12/1 | | Regulation (derived from) | Industry-Standard Notice 2006 No. 2 (total No. 74) |
YY 0118-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0118-2005
Joint Replacement Implants –
Hip Joint Prostheses
关节置换植入物－髋关节假体
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 8
4 Classification and Size Marking ... 8
5 Expected Performance ... 8
6 Design Attributes ... 8
7 Materials ... 8
8 Design Evaluation ... 11
9 Manufacture ... 15
10 Sterilization ... 15
11 Package ... 16
12 Information Provided by Manufacturer ... 16
Appendix A ... 17
Appendix B ... 19
Appendix C ... 21
Appendix D ... 23
Foreword
Clause 7.7.4 of this Standard is recommendatory, while the rest are mandatory.
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard replaces YY 0118-2005 Hip Joint Prostheses. Compared with YY
0118-2005, the main changes in this Standard are as follows.
--- Add the oxidation stability and morphological evaluation of ultrahigh molecular
weight polyethylene (see Clause 7.3.1 of this version);
--- Add the requirements for extensively radiation cross-linked ultrahigh molecular
weight polyethylene (see Clause 7.3.2 of this version);
--- Add the requirements for plasma spraying metal coating (see Clause 7.5.2 of
this version);
--- Modify the applicable scope of surface defects (see Clause 8.3 of this version;
and Clause 4.2.2 of Version 2005);
--- Add femoral head fixed anti-torque performance measurement against the
stemmed femoral component (see Clause 8.6.1 of this version);
--- Add the combined femoral head anti-static load force (see Clause 8.6.2 of this
version);
--- Add metal acetabular resistance to deformation (see Clause 8.6.3 of this
version);
--- Modify the shank fatigue performance of stemmed femoral components, and
amending it as mandatory clause (see Clause 8.7.2 of this version; and Clause
5.3.1 of Version 2005);
--- Modify the head and neck fatigue performance of stemmed femoral components,
and amending it as mandatory clause (see Clause 8.7.3 of this version; and
Clause 5.3.2 of Version 2005);
--- Add the maximum and minimum angles (see Clause 8.8 of this version);
--- Delete the inspection rules in the original standard (see Chapter 7 of Version
2005).
Please note that some contents of this document may involve patents. The releasing
organization of this document shall not assume the responsibility for identifying these
patents.
Joint Replacement Implants - Hip Joint
Prostheses
1 Scope
This Standard specifies the terms and definitions, classification and size marking,
expected performance, design attributes, materials, design evaluation, manufacture,
sterilization, packing, and manufacturer’s information requirements for the total-hip
and partial-hip joint prostheses.
This Standard is applicable to manufacture total-hip and partial-hip joint prostheses
used the materials and processes specified in this Standard.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this standard.
GB/T 10610 Geometrical Product Specifications (GPS) - Surface Texture. Profile
Method - Rules and Procedures for the Assessment of Surface Texture
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 18278 Sterilization of Health Care Products - Requirements for Validation and
Routine Control - Industrial Moist Heat Sterilization
GB 18279 Medical Devices-Validation and Routine Control of Ethylene Oxide
Sterilization
GB 18280 Sterilization of Health Care Products - Requirement for Validation and
Routine Control - Radiation Sterilization
GB/T 19701.1 Implants for Surgery - Ultra-high Molecular Weight Polyethylene -
Part 1. Powder Form
GB/T 19701.2 Implants for Surgery Ultra-high Molecular Weight Polyethylene -
Part 2. Moulded Forms
GB 23101.2 Implants for Surgery - Hydroxyapatite - Part 2. Coatings of
Hydroxyapatite
YY 0117.1 Implants for Surgery - Forgings, Castings for Bone Joint Prostheses -
Ti6Al4V Titanium Alloy Forgings
YY 0117.2 Implants for Surgery - Forgings, Castings for Bone Joint
Prostheses-ZTi6Al4V Titanium Alloy Castings
YY 0117.3 Implants for Surgery - Forgings, Castings for Bone Joint Prostheses
Cobalt Chromium Molybdenum Alloy Castings
YY/T 0772.3 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -
Part 3. Accelerated Ageing Methods
YY/T 0772.4 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -
Part 4. Oxidation Index Measurement Method
YY/T 0772.5 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -
Part 5. Morphology Assessment Method
YY/T 0809.1 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 1.
Classification and Designation of Dimensions (YY/T 0809.1-2010, ISO
7206-1.2008, IDT)
YY/T 0809.2 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 2.
Articulating Surfaces Made of Metallic, Ceramic and Plastics Materials (YY/T
0809.2-2010, ISO 7206-2.1996, IDT)
YY/T 0811 Standard Guide for Extensively Irradiation - Crosslinked Ultrahigh
Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
YY/T 0920 Non-Active Surgical Implants - Joint Replacement Implants - Specific
Requirements for Hip-Joint Replacement Implants (YY/T 0920-2014, ISO
21535.2007, IDT)
ISO 4287 Geometrical Product Specification (GPS) - Surface Texture. Profile
Method - Terms, Definitions and Surface Texture Parameters
ISO 6474-1 Implants for Surgery – Ceramic Materials – Part 1. Ceramic Materials
Based on High Purity Alumina
ISO 6474-2 Implants for Surgery – Ceramic Materials – Part 2. Composite
Materials Based on a High Purity Alumina Matrix with Zirconia Reinforcement
ISO 7206-4 Implants for Surgery – Partial and Total Hip Joint Prostheses – Part 4.
Determination of Endurance Properties of Stemmed Femoral Components
ISO 7206-6 Implants for Surgery – Partial and Total Hip Joint Prostheses – Part 6.
Determination of Endurance Properties of Head and Neck Region of Stemmed
Femoral Components
ISO 7206-10 Implants for Surgery - Partial and Total Hip Joint Prostheses – Part 10.
Determination of Resistance to Static Load of Modular Femoral Heads
ISO 13356 Implants for Surgery – Ceramic Materials Based on Yttria-Stablized
Tetragonal Zirconia (Y-TZP)
ISO 14242-1 Implants for Surgery – Wear of Total Hip-Joint Prostheses - Part 1.
Loading and Displacement Parameters for Wear-Testing Machines Corresponding
Environmental Conditions for Test
ISO 4242-2 Implants for Surgery – Wear of Total Hip-Joint Prostheses – Part 2.
Methods of Measurement
ISO 4242-3 Implants for Surgery – Wear of Total Hip-Joint prostheses - Part 3.
Loading and Displacement Parameters for Orbital Bearing Type Wear Testing
Machines and Corresponding Environmental Conditions for Test
ISO 14630 Non-Active Surgical Implants – General Requirements
ISO 21534 Non-Active Surgery Implants – Joint Replacement Implants – particular
Requirements
ASTM F1044 Standard Test Method for Shear Testing of Calcium Phosphate
Coating and Metallic Coating
ASTM F1147 Standard Test Method for Tension Testing of Calcium Phosphate
Coating and Metallic Coating
ASTM F1160 Standard Test Method for Shear and Bending Testing of Calcium
Phosphate and Metallic Medical and Composite Calcium Phosphate/metallic
coating
ASTM F1377 Standard Specification for Cobalt-28Chromium-6Molybdenum Power
for Coating of Orthopaedic Implants
ASTM F1580 Standard Specification for Titanium and
Titanium-6Aluminum-4Vanadium Alloy Powders for Coating of Surgical Implants
ASTM F1854 Standard Test Method for Stereo-Logical Evaluation of Porous
Coating on Medical Implants
ASTM F1978 Stand...
......
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,
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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