All the technical contents of this Standard are compulsory.
This Standard is drafted according to rules given in GB/T 1.1-2009.
This Standard supersedes YY 0017-2008 Implants for Osteosynthesis - Metallic Bone Plates; compared with YY 0017-2008, this Standard has the following main technical differences:
- Application scope of the product is modified and this Standard is no longer applicable to angle fixer (see Chapter 1);
- Contents of "classification and designation" in Chapter 3 of Edition 2008 are deleted;
- Terms and definitions are added (see Chapter 3);
- The note "For reconstruction plate, the manufacturer may specify the hardness of the product according to clinical demands" is added (see Table 1);
- The note "For the surface roughness of the bond plates with special surface treatment (for example, sand blasting), relevant requirements may be established by the manufacturer according to clinical requirements" is added (see Table 2);
- Requirements for fatigue performance of bone plate are added (see 4.2.3);
- Relevant requirements for evaluation of the product with anodic oxidation surface treatment are added (see 4.4.4);
- Contents of "inspection rules", "transportation and storage" and "service requirements" were deleted (see Chapters 6, 10 and 11 of Edition 2008);
- Requirements for "manufacture" and "sterilization" are added (see Chapters 6 and 7);
- Appendixes A and B are added, and Appendix A of Edition 2008 is revised as Appendix C.
This Standard revises YY 0017-2008 Implants for Osteosynthesis - Metallic Bone Plates according to the basic requirements of YY 0341-2009 General Technological Requirements for Non-active Metallic Surgical Implementations for Osteosynthesis and by reference to ASTM F382 Standard Specification and Test Method for Metallic Bone Plates. The dimension of holes and slots in this Standard are adopted by reference to ISO 5836:1988 Implants for Surgery - Metal Bone Plates - Holes Corresponding to Screws with Asymmetrical Thread and Spherical Under-surface and ISO 9269:1988 Implants for Surgery - Metal Bone Plates - Holes and Slots Corresponding to Screws with Conical Under-surface.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. Issue organization of this document shall not be held responsible for identifying any or all such patent rights.
This Standard is proposed by and is under the jurisdiction of Subcommittee on Orthopaedic Implants of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China (SAC/TC 110/SC 1).
Drafting organizations of this Standard: Tianjin Medical Device Quality Supervision and Inspection Center and Center for Medical Device Evaluation, SFDA.
Chief drafters of this Standard: Jiang Xi, Dong Shuangpeng, Meng Tao, Song Duo, Guo Xiaolei and Zhang Jiazhen.
This Standard supersedes YY 0017-2008.
Previous editions of YY 0017-2008 are as follows:
- YY 0017-1990 and YY 0017-2002.
PROFESSIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
中华人民共和国行业标准
YY 0017-2016
Supersedes YY 0017-2008
Implants for Osteosynthesis - Metallic Bone Plates
骨接合植入物 金属接骨板
1 Scope
This Standard specifies relevant terms and definitions, requirements, test methods, manufacture, sterilization, packaging and information supplied by manufacturer of the implants for osteosynthesis - metallic bone plates (hereafter referred to as "bone plate").
This Standard is applicable to the bone plates for union with the broken ends of fractured bone during orthopedic surgery. This Standard is not applicable to all the types of bone plates, and the user shall investigate the applicability of this Standard in combination with specific types and intended uses of the bone plates and specify corresponding product performance requirements.
Neither is this Standard applicable to craniofacial-maxillofacial bone plates, angle fixers and spine fixation plates etc., nor does it contain description and requirements of the bone plates in the special design.
2 Normative References
The following documents for the application of this document are essential. Any dated reference, only the edition cited applies. For undated reference, the latest edition of the normative document (including any amendments) applies.
GB 4234 Stainless Steel for Surgical Implants
GB/T 4340.1 Metallic Materials - Vickers Hardness Test - Part 1: Test Method
GB/T 10610 Geometrical Product Specifications (GPS) - Surface Texture: Profile Method - Rules and Procedures for the Assessment of Surface Texture
GB/T 13810 Wrought Titanium and Titanium Alloy for Surgical Implants
GB/T 16886.5 Biological Evaluation of Medical Devices - Part 5: Test for in Vitro Cytotoxicity
GB 23102 Implants for surgery - Metallic Materials - Wrought Titanium -6Aluminium-7Niobium Alloy
YY 0018 Implants for Osteosynthesis - Metallic Bone Screws
YY/T 1074 Implants for Surgery - Measuring Method for Pitting Corrosion Potential on Stainless Products
YY/T 0342 Implants for Surgery - Determination of Bending Strength and Stiffness of Bone Plates
YY/T 0343 Liquid Penetrant Inspection of Metallic Surgical Implants
YY 0605.9 Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel
YY/T 0640 Non-active Surgical Implants - General Requirements
YY/T 1503 Surgical Implants for Metal Plate Bending Fatigue Test Method
ISO 5836 Implants for Surgery - Metal Bone Plates - Holes Corresponding to Screws with Asymmetrical Thread and Spherical Under-Surface
ISO 9269 Implants for Surgery - Metal Bone Plates - Holes and Slots Corresponding to Screws with Conical Under-surface
3 Terms and Definitions
For the purposes of this document, terms and definitions established in YY/T 1503 and the following ones apply.
3.1
Non-active surgical implant for osteosynthesis
Non-active surgical implant product intended to provide support to bony, cartilaginous, tendoninous or ligamentous structures.
3.2
Metallic bone plate
A metallic device with two or more holes or slots, or both, and a cross section that consists of at least two dimensions (width and thickness) which generally are not the same in magnitude. The device is intended to provide alignment and fixation of two or more bone sections. The device is typically fixed to the bone through the use of bone screws or cerclage wire.
Note: typical types of bone plates are given in Appendix A.
3.3
Auto compression
A type of bone plate that by its design can generate a compressive force between adjacent unconnected bone fragments through the use of one or more ramped holes or slots. This ramp or slot geometry contacts the underside of the screw head, and induces compressive force as the screw is inserted and tightened to the bone plate.
3.4
Bone plate length
L
The linear dimension of the bone plate measured along the longitudinal axis as illustrated in Figure 1.
Note: in mm.
3.5
Bone plate thickness
b
The linear dimension of the bone plate measured parallel to the screw hole axis as shown in Figures 1, 2a) and 2b).
For a bone plate with a crescent section, the thickness is measured at the thickest point along the section.
Note: in mm.
3.6
Bone plate width
w
The linear dimension of the bone plate measured perpendicular to both the length and thickness axes as shown in Figure 1.
Note: in mm.
Figure 1 Dimensions of Bone Plates
Figure 2 Cross Sections of Bone Plates
3.7
Contouring
The manipulation and bending of a bone plate, either pre-operatively or intra-operatively, to match the anatomic geometry of the intended fixation location.
3.8
Crescent section
A bone plate cross-section shape (perpendicular to the long axis of the bone plate) where the thickness is not constant along the section. Typically the section is thickest along the bone plate’s centerline and tapers to a smaller thickness at the bone plate’s edges.
4 Requirements
4.1 Materials
4.1.1 General
Bone plates shall give priority to metal materials for surgical implants specified in international standards, national standards and professional standards.
Materials selected for the bone plates include, but not limited to the following materials.
4.1.2 Stainless steel materials
Stainless steel bone plates shall give priority to the materials specified in GB 4234 or YY 0605.9.
4.1.3 Titanium and titanium alloy materials
Titanium and titanium alloy bone plates shall give priority to the materials specified in GB/T 13810 or GB 23102.
4.2 Mechanical performance
4.2.1 Hardness
Hardness of the bone plates shall be in accordance with those specified in Table 1.
Table 1 Hardness
Material Hardness/HV10
Stainless steel ≥210
Titanium alloy ≥260
Pure titanium ≥150
Note: for the reconstruction plate requiring contouring, the manufacturer may specify the hardness of the product according to clinical demands.
4.2.2 Bending strength and equivalent bending stiffness
For the bone plates in accordance with YY/T 0342, the manufacturer shall specify their bending strength and equivalent bending stiffness.
4.2.3 Fatigue performance
The manufacturer shall specify fatigue strength of the bone plates under 106 cyclic load.
4.3 Corrosion resistance
Potential value of pitting corrosion on final product surfaces of the bone plates (Eb) shall not be less than 800mV.
4.4 Surface quality
4.4.1 Surface defect
The surfaces of the bone plates shall be free from any discontinuous defect.
4.4.2 Surface roughness
Surface roughness value of the bone plates Ra shall not be greater than that specified in Table 2.
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Methods
6 Manufacture
7 Sterilization
8 Packaging
9 Information Supplied by Manufacturer
Appendix A (Informative) Typical Types of Metallic Bone Plates
Appendix B (Normative) Holes and Slots for Bone Plates in Accordance with ISO 5836 and ISO
Appendix C (Informative) List of Approved Method Standards for Chemical Analysis
Bibliography
All the technical contents of this Standard are compulsory.
This Standard is drafted according to rules given in GB/T 1.1-2009.
This Standard supersedes YY 0017-2008 Implants for Osteosynthesis - Metallic Bone Plates; compared with YY 0017-2008, this Standard has the following main technical differences:
- Application scope of the product is modified and this Standard is no longer applicable to angle fixer (see Chapter 1);
- Contents of "classification and designation" in Chapter 3 of Edition 2008 are deleted;
- Terms and definitions are added (see Chapter 3);
- The note "For reconstruction plate, the manufacturer may specify the hardness of the product according to clinical demands" is added (see Table 1);
- The note "For the surface roughness of the bond plates with special surface treatment (for example, sand blasting), relevant requirements may be established by the manufacturer according to clinical requirements" is added (see Table 2);
- Requirements for fatigue performance of bone plate are added (see 4.2.3);
- Relevant requirements for evaluation of the product with anodic oxidation surface treatment are added (see 4.4.4);
- Contents of "inspection rules", "transportation and storage" and "service requirements" were deleted (see Chapters 6, 10 and 11 of Edition 2008);
- Requirements for "manufacture" and "sterilization" are added (see Chapters 6 and 7);
- Appendixes A and B are added, and Appendix A of Edition 2008 is revised as Appendix C.
This Standard revises YY 0017-2008 Implants for Osteosynthesis - Metallic Bone Plates according to the basic requirements of YY 0341-2009 General Technological Requirements for Non-active Metallic Surgical Implementations for Osteosynthesis and by reference to ASTM F382 Standard Specification and Test Method for Metallic Bone Plates. The dimension of holes and slots in this Standard are adopted by reference to ISO 5836:1988 Implants for Surgery - Metal Bone Plates - Holes Corresponding to Screws with Asymmetrical Thread and Spherical Under-surface and ISO 9269:1988 Implants for Surgery - Metal Bone Plates - Holes and Slots Corresponding to Screws with Conical Under-surface.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. Issue organization of this document shall not be held responsible for identifying any or all such patent rights.
This Standard is proposed by and is under the jurisdiction of Subcommittee on Orthopaedic Implants of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China (SAC/TC 110/SC 1).
Drafting organizations of this Standard: Tianjin Medical Device Quality Supervision and Inspection Center and Center for Medical Device Evaluation, SFDA.
Chief drafters of this Standard: Jiang Xi, Dong Shuangpeng, Meng Tao, Song Duo, Guo Xiaolei and Zhang Jiazhen.
This Standard supersedes YY 0017-2008.
Previous editions of YY 0017-2008 are as follows:
- YY 0017-1990 and YY 0017-2002.
PROFESSIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
中华人民共和国行业标准
YY 0017-2016
Supersedes YY 0017-2008
Implants for Osteosynthesis - Metallic Bone Plates
骨接合植入物 金属接骨板
1 Scope
This Standard specifies relevant terms and definitions, requirements, test methods, manufacture, sterilization, packaging and information supplied by manufacturer of the implants for osteosynthesis - metallic bone plates (hereafter referred to as "bone plate").
This Standard is applicable to the bone plates for union with the broken ends of fractured bone during orthopedic surgery. This Standard is not applicable to all the types of bone plates, and the user shall investigate the applicability of this Standard in combination with specific types and intended uses of the bone plates and specify corresponding product performance requirements.
Neither is this Standard applicable to craniofacial-maxillofacial bone plates, angle fixers and spine fixation plates etc., nor does it contain description and requirements of the bone plates in the special design.
2 Normative References
The following documents for the application of this document are essential. Any dated reference, only the edition cited applies. For undated reference, the latest edition of the normative document (including any amendments) applies.
GB 4234 Stainless Steel for Surgical Implants
GB/T 4340.1 Metallic Materials - Vickers Hardness Test - Part 1: Test Method
GB/T 10610 Geometrical Product Specifications (GPS) - Surface Texture: Profile Method - Rules and Procedures for the Assessment of Surface Texture
GB/T 13810 Wrought Titanium and Titanium Alloy for Surgical Implants
GB/T 16886.5 Biological Evaluation of Medical Devices - Part 5: Test for in Vitro Cytotoxicity
GB 23102 Implants for surgery - Metallic Materials - Wrought Titanium -6Aluminium-7Niobium Alloy
YY 0018 Implants for Osteosynthesis - Metallic Bone Screws
YY/T 1074 Implants for Surgery - Measuring Method for Pitting Corrosion Potential on Stainless Products
YY/T 0342 Implants for Surgery - Determination of Bending Strength and Stiffness of Bone Plates
YY/T 0343 Liquid Penetrant Inspection of Metallic Surgical Implants
YY 0605.9 Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel
YY/T 0640 Non-active Surgical Implants - General Requirements
YY/T 1503 Surgical Implants for Metal Plate Bending Fatigue Test Method
ISO 5836 Implants for Surgery - Metal Bone Plates - Holes Corresponding to Screws with Asymmetrical Thread and Spherical Under-Surface
ISO 9269 Implants for Surgery - Metal Bone Plates - Holes and Slots Corresponding to Screws with Conical Under-surface
3 Terms and Definitions
For the purposes of this document, terms and definitions established in YY/T 1503 and the following ones apply.
3.1
Non-active surgical implant for osteosynthesis
Non-active surgical implant product intended to provide support to bony, cartilaginous, tendoninous or ligamentous structures.
3.2
Metallic bone plate
A metallic device with two or more holes or slots, or both, and a cross section that consists of at least two dimensions (width and thickness) which generally are not the same in magnitude. The device is intended to provide alignment and fixation of two or more bone sections. The device is typically fixed to the bone through the use of bone screws or cerclage wire.
Note: typical types of bone plates are given in Appendix A.
3.3
Auto compression
A type of bone plate that by its design can generate a compressive force between adjacent unconnected bone fragments through the use of one or more ramped holes or slots. This ramp or slot geometry contacts the underside of the screw head, and induces compressive force as the screw is inserted and tightened to the bone plate.
3.4
Bone plate length
L
The linear dimension of the bone plate measured along the longitudinal axis as illustrated in Figure 1.
Note: in mm.
3.5
Bone plate thickness
b
The linear dimension of the bone plate measured parallel to the screw hole axis as shown in Figures 1, 2a) and 2b).
For a bone plate with a crescent section, the thickness is measured at the thickest point along the section.
Note: in mm.
3.6
Bone plate width
w
The linear dimension of the bone plate measured perpendicular to both the length and thickness axes as shown in Figure 1.
Note: in mm.
Figure 1 Dimensions of Bone Plates
Figure 2 Cross Sections of Bone Plates
3.7
Contouring
The manipulation and bending of a bone plate, either pre-operatively or intra-operatively, to match the anatomic geometry of the intended fixation location.
3.8
Crescent section
A bone plate cross-section shape (perpendicular to the long axis of the bone plate) where the thickness is not constant along the section. Typically the section is thickest along the bone plate’s centerline and tapers to a smaller thickness at the bone plate’s edges.
4 Requirements
4.1 Materials
4.1.1 General
Bone plates shall give priority to metal materials for surgical implants specified in international standards, national standards and professional standards.
Materials selected for the bone plates include, but not limited to the following materials.
4.1.2 Stainless steel materials
Stainless steel bone plates shall give priority to the materials specified in GB 4234 or YY 0605.9.
4.1.3 Titanium and titanium alloy materials
Titanium and titanium alloy bone plates shall give priority to the materials specified in GB/T 13810 or GB 23102.
4.2 Mechanical performance
4.2.1 Hardness
Hardness of the bone plates shall be in accordance with those specified in Table 1.
Table 1 Hardness
Material Hardness/HV10
Stainless steel ≥210
Titanium alloy ≥260
Pure titanium ≥150
Note: for the reconstruction plate requiring contouring, the manufacturer may specify the hardness of the product according to clinical demands.
4.2.2 Bending strength and equivalent bending stiffness
For the bone plates in accordance with YY/T 0342, the manufacturer shall specify their bending strength and equivalent bending stiffness.
4.2.3 Fatigue performance
The manufacturer shall specify fatigue strength of the bone plates under 106 cyclic load.
4.3 Corrosion resistance
Potential value of pitting corrosion on final product surfaces of the bone plates (Eb) shall not be less than 800mV.
4.4 Surface quality
4.4.1 Surface defect
The surfaces of the bone plates shall be free from any discontinuous defect.
4.4.2 Surface roughness
Surface roughness value of the bone plates Ra shall not be greater than that specified in Table 2.
Contents of YY 0017-2016
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Methods
6 Manufacture
7 Sterilization
8 Packaging
9 Information Supplied by Manufacturer
Appendix A (Informative) Typical Types of Metallic Bone Plates
Appendix B (Normative) Holes and Slots for Bone Plates in Accordance with ISO 5836 and ISO
Appendix C (Informative) List of Approved Method Standards for Chemical Analysis
Bibliography
