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YY 0017-2016: Implants for osteosynthesis - Metallic bone plates
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Basic data | Standard ID | YY 0017-2016 (YY0017-2016) | | Description (Translated English) | Implants for osteosynthesis - Metallic bone plates | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 19,158 | | Date of Issue | 2002-01-01 | | Date of Implementation | 2018-06-01 | | Older Standard (superseded by this standard) | YY 0017-2008 | | Quoted Standard | GB 4234; GB/T 4340.1; GB/T 10610; GB/T 13810; GB/T 16886.5; GB 23102; YY 0018; YY/T 1074; YY/T 0342; YY/T 0343; YY 0605.9; YY/T 0640; YY/T 1503; ISO 5836; ISO 9269 | | Regulation (derived from) | State Food and Drug Administration Announcement No. 2016 (No. 129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the relevant terms and definitions, requirements, test methods, manufacturing, sterilization, packaging, and information provided by the manufacturer of bone graft implants - metal plates (hereinafter referred to as "plate"). This standard applies to osteotomy for orthopedic surgery for fracture connection. This standard does not apply to all types of plate, the user should be combined with the specific type of plate and the intended use of the applicability of this standard, and provide the corresponding product performance requirements. This standard does not apply to the craniomaxillofacial plate, angle fixator, spinal fixation plate, etc., does not contain the description of the special design of the plate and requirements. | YY 0017-2016: Implants for osteosynthesis - Metallic bone plates---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for osteosynthesis - Metallic bone plates
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0017-2008
Bone-engagement implant metal plate
Released on.2016-07-29
2018-06-01 implementation
State Food and Drug Administration issued
Content
Foreword I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 3
5 Test method 4
6 Manufacturing 5
7 sterilization 5
8 Packing 6
9 Information provided by the manufacturer 6
Appendix A (informative) Several typical types of metal plates 7
Appendix B (Normative) Holes and grooves 8 of the plate in ISO 5836 and ISO 9269
Appendix C (informative) List of approved method standards for chemical analysis 14
Reference 15
Foreword
The full technical content of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0017-2008 "Bone-joined implant metal plate", compared with YY 0017-2008, the main technical difference
The difference is as follows.
--- Modify the scope of application of the product, the standard is no longer applicable to the angle fixture (see Chapter 1);
--- Delete the contents of Chapter 3 "Classification and Naming" in the.2008 edition;
--- Added terms and definitions (see Chapter 3);
--- Added the note "For the reconstruction of the bone plate, the manufacturer can specify the hardness of the product according to clinical needs" (see Table 1);
--- Added "The surface roughness of the bone plate for special surface treatment (such as sand blasting) can be determined by the manufacturer according to clinical needs
Notes on relevant requirements (see Table 2);
--- Increased the fatigue performance of the butt joints (see 4.2.3);
--- Added provisions for the evaluation of anodized surface treatment products (see 4.4.4);
--- Deleted the contents of "inspection rules", "transport and storage" and "use requirements" (see Chapter 6, Chapter 10, Chapter 11 of the.2008 edition);
--- Added provisions for "manufacturing" and "sterilization" (see Chapters 6 and 7);
--- Added Appendix A and Appendix B, and Appendix A of the.2008 version was revised to Appendix C.
This standard is in accordance with the basic requirements of YY 0341-2009 "General Technical Conditions for Passive Surgical Implants for Bone Bonding" and refers to ASTM
F382 "Standard Specification and Test Method for Metal Plates", for YY 0017-2008 "Bone Joint Implant Metal Bone
Board has been revised. The dimensions of the holes and grooves in this standard refer to ISO 5836.1988 "Surgical Implant Metal Plates and
Asymmetric threads, corresponding holes for spherical lower surface screws" and ISO 9269.1988 "Surgical implant metal plates and conical lower surfaces
Corresponding holes and slots.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard is administered by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, orthopedic implants subcommittee (SAC/TC110/
SC1) proposed and managed.
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, State Food and Drug Administration, Medical Device Technology Review
Evaluation center.
The main drafters of this standard. Jiang Xi, Dong Shuangpeng, Meng Tao, Song Yi, Guo Xiaolei, Zhang Jiazhen.
This standard replaces YY 0017-2008.
The previous versions of YY 0017-2008 were released as follows.
---YY 0017-1990, YY 0017-2002.
Bone-engagement implant metal plate
1 Scope
This standard specifies the relevant terms and definitions, requirements, and test methods for bone-engaged implants--metal plate (hereinafter referred to as "the bone plate").
Information, manufacturing, sterilization, packaging and information provided by the manufacturer.
This standard is applicable to bone plates for fracture end connection during orthopedic surgery. This standard does not apply to all types of bone plates.
The user should examine the applicability of this standard in conjunction with the specific type and intended use of the bone plate and specify the performance requirements of the corresponding product.
This standard does not apply to craniomaxillofacial bone plates, angle fixators, spinal fixation plates, etc., and does not include descriptions of specially designed bone plates and
Claim.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 4234 stainless steel for surgical implants
GB/T 4340.1 Vickers hardness test for metallic materials - Part 1. Test methods
GB/T 10610 Product Geometrical Specification (GPS) Surface structure profiling rules and methods for assessing surface structures
GB/T 13810 surgical implants with titanium and titanium alloy processing materials
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test
GB 23102 Surgical Implant Metal Material Ti-6Al-7Nb Alloy Processing Material
YY 0018 bone cement implant metal bone screw
YY/T 1074 surgical implant stainless steel product pitting potential
YY/T 0342 Determination of flexural strength and stiffness of surgical implant plates
YY/T 0343 Surgical metal implant liquid penetration test
Surgical implants - Metal materials - Part 9. Forged high-nitrogen stainless steel
YY/T 0640 General requirements for passive surgical implants
YY/T 1503 surgical implant metal plate bending fatigue performance test method
ISO 5836 Surgical Implants Metal Plates with Asymmetric Threads and Spherical Lower Surface Screws (Implantsfor
surgery-Metalboneplates-Holescorrespondingtoscrewswithasymmetricalthreadandspherical
Under-surface)
ISO 9269 Surgical implant metal plate with holes and slots for tapered lower surface screws (Implantsforsurgery-
Metalboneplates-Holesandslotscorrespondingtoscrewswithconicalunder-surface)
3 Terms and definitions
The following terms and definitions defined by YY/T 1503 apply to this document.
3.1
Bone-joint passive surgical implant non-activesurgicalimplantforosteosynthesis
A passive surgical implant for supporting bone, cartilage, tendon or ligament structures.
3.2
Metal plate metalicboneplate
A metal instrument used primarily to connect two or more bones after a fixed fracture, with two or more holes and/or slots, cross section to
There are two directions (width and thickness) that can be clearly distinguished. The bone plate is fixed to the bone mainly by screws or wire.
Note. Appendix A gives several typical versions of metal plates.
3.3
Power pressurization autocompression
The design of the bone plate through one or more inclined holes or slots creates pressure between adjacent broken bones. Such a slanted hole or
The groove is in contact with the lower surface of the screw head, and pressure is generated as the screw is screwed in and tightened.
3.4
Bone plate length boneplatelength
The linear dimension of the long axis of the plate, as shown in Figure 1.
Note. The unit is mm.
3.5
Bone plate thickness boneplatethickness
The bone plate has a linear dimension parallel to the direction of the hole, as shown in Figures 1 and 2a), Figure 2b).
The thickness of the tubular plate is taken to be the thickest part of the cross section.
Note. The unit is mm.
3.6
Bone plate width boneplatewidth
The linear dimension of the plate perpendicular to the length and thickness directions is shown in Figure 1.
Note. The unit is mm.
Figure 1 size of the bone plate
a) b)
Figure 2 Cross section of the bone plate
3.7
Contouring
In order to adapt the bone plate to the geometrical characteristics of the anatomical part, the bending of the bone plate is performed before or during the operation.
3.8
Crescent-shaped cross section crescentsection
A cross-section of a bone plate (perpendicular to the long axis of the bone plate) in which the thickness is inconsistent. Typical crescent cross
The surface has the largest thickness along the center line of the bone plate, and gradually becomes smaller toward the edge of the bone plate, and the thickness at the edge is the smallest.
4 requirements
4.1 Materials
4.1.1 General
The bone plate should be selected from the surgical implant metal materials specified by international standards, national standards and industry standards.
Materials selected for the bone plate include, but are not limited to, the following materials.
4.1.2 Stainless steel material
Stainless steel plate should be selected according to the provisions of GB 4234 or YY 0605.9.
4.1.3 Titanium and titanium alloy materials
Titanium and titanium alloy bone plates should be selected according to the provisions of GB/T 13810 or GB 23102.
4.2 Mechanical properties
4.2.1 Hardness
The hardness of the bone plate should meet the requirements of Table 1.
Table 1 hardness
Material hardness/HV10
Stainless steel ≥210
Titanium alloy ≥260
Pure titanium ≥150
Note. For reconstructed bone plates that require shaping, the manufacturer can specify the hardness of the product based on clinical needs.
4.2.2 Bending strength and equivalent bending stiffness
For bone plates complying with YY/T 0342, the manufacturer shall specify the bending strength and equivalent bending stiffness.
4.2.3 Fatigue performance
Manufacturers should specify the fatigue strength of the bone plate under 106-cycle load conditions.
4.3 Corrosion resistance
The pitting potential (Eb) of the surface of the stainless steel plate should not be less than 800mV.
4.4 Surface quality
4.4.1 Surface defects
The surface of the plate must not have discontinuities.
4.4.2 Surface roughness
The surface roughness Ra of the bone plate should not be greater than that specified in Table 2.
Table 2 Surface roughness in microns
Material type hole, groove smooth inner surface smooth outer surface
stainless steel
Titanium and titanium alloy
3.2
0.8 0.4
1.6 0.8
Note. The surface roughness of the special surface treatment (such as sandblasting) bone plate can be determined by the manufacturer according to clinical needs.
4.4.3 Appearance
The surface of the bone plate shall be free from defects such as scale, knife marks, small gaps, scratches, cracks, depressions, sharp edges, burrs, etc.
Work sediments and other pollutants.
4.4.4 Surface treatment
After the anodized surface of the bone plate, it should be subjected to qualitative analysis of surface elements and evaluation of cytotoxicity.
4.5 Geometric characteristics
4.5.1 In clinical use, since the bone plate needs to be used in conjunction with the bone screw, the shape of the hole or groove of the bone plate should be corresponding
The bone screws match.
4.5.2 It is expected that the hole and groove size d1 and d of the bone plate used in conjunction with the bone screw conforming to YY 0018 shall conform to ISO 5836 respectively.
Or the requirements in ISO 9269 (see Appendix B).
4.5.3 The dimensions and tolerances of the special series of bone plate holes or slots may be specified by the manufacturer.
5 Test methods
5.1 Materials
Chemical composition and microstructure should be sampled on the final product, according to the method specified in the selected material standard or the method recommended in Appendix C.
Line test.
5.2 Mechanical properties
5.2.1 Hardness
According to the provisions of GB/T 4340.1, the number of samples is 3.
5.2.2 Bending strength and equivalent bending stiffness
According to YY/T 0342, the number of samples is 3 pieces.
5.2.3 Fatigue performance
In accordance with the provisions of YY/T 1503.
5.3 Corrosion resistance
According to YY/T 1074, the number of samples is 3.
5.4 Surface quality
5.4.1 Surface defects
According to YY/T 0343, the number of samples is 3 pieces.
5.4.2 Surface roughness
The test is carried out by using the sample comparison method or the electrical measurement method, and the number of samples is 3 pieces, and the electrical measurement method is an arbitration test method. When using electrical measurement, it should be pressed
According to the provisions of GB/T 10610.
5.4.3 Appearance
The test was carried out by eye observation, and the number of samples was 10.
5.4.4 Surface treatment
Qualitative analysis of surface elements was carried out by scanning electron microscopy.
Cytotoxicity was carried out in accordance with the provisions of GB/T 16886.5.
5.5 Geometric characteristics
It is inspected with a universal measuring tool or a special inspection tool, and the number of samples is 10.
6 manufacturing
Should comply with the provisions of YY/T 0640.
7 sterilization
Should comply with the provisions of YY/T 0640.
8 packaging
Should comply with the provisions of YY/T 0640.
9 Information provided by the manufacturer
9.1 label
Should comply with the provisions of YY/T 0640.
9.2 mark
It shall comply with the provisions of YY/T 0640, and the marked position shall be as far as possible from the main stress bearing area.
9.3 User's Manual
Should comply with the provisions of YY/T 0640.
Appendix A
(informative appendix)
Several typical types of metal plates
Typical types of bone plates used in orthopedic surgery include, but are not limited to.
a) Straight bone plates. These bone plates are generally uniform in width and have a straight longitudinal axis. This bone plate is often used for long bones
Treatment of fractures at the site.
b) Tubular plates. These plates have a cross-section that is approximately tubular and has a uniform cross-section thickness or crescent shape. This type of bone plate is commonly used
Fracture treatment of small long bones such as the humerus, ulna, and tibia.
c) Reconstruction of the bone plate. This type of bone plate is characterized by a small cross section between the hole or groove of the bone plate, so the width of the bone plate
Degree is changing. Reducing the cross-section between the holes or slots facilitates shaping the plate to form a plurality of planes. This bone plate
Not suitable for fractures of complex three-dimensional geometry, such as the pelvis, acetabulum, upper humerus and clavicle.
d) Cobra-shaped bone plates. These bone plates have an abducted triangular or trapezoidal end that contains a plurality of holes and/or grooves. This connection
Bone plates are often used for hip surgery.
e) Trilobal plate. This plate has a perforated end with a hole.
f) Locking the bone plate. The hole in the bone plate of this type contains a threaded structure by locking the taper thread of the lower surface of the screw head with the hole of the plate
The corresponding threads are adapted to effectively secure the locking screw to the bone plate and bone. Some of these bone plates only contain
The locking holes of the locking screws are inserted into the locking holes, and some have associated holes that can be selectively inserted into the normal or locking screws. Joint hole
The power pressurizing portion is used to insert a normal screw, and the threaded portion is used to insert a locking screw.
Note. The above-mentioned examples of the type of bone plate given in this appendix are for reference only to standard users, and are not used as the basis for the classification of bone plates and the determination of typical samples.
Appendix B
(normative appendix)
Holes and slots for bone plates in ISO 5836 and ISO 9269
B.1 Type A (cylindrical hole)
Figure B.1 Type A hole
Table B.1 A-type hole size is in millimeters
D1 d2
Dimensional tolerance dimensional tolerance
Minimum value
The cylindrical part of the counterbore (depending on a)
Dimensional tolerance
Aref
Screw in YY 0018
1.6
1.9
2.1
2.6
2.9
3.4
3.7
4.2
4.7
5.5
5.2
6.0
6.6
0.2
3.1
3.2
4.1
4.3
5.2
5.4
6.2
6.4
8.2
0.2
0.15
0.25
0.10
0.25
0.15
0.30
0.25
0.40
0.35
0.75
0.60
1.0
1.3
0.4
0.6
0.9
1.4
-0.2
1.3
1.5
1.9
2.4
3.5
HA1.5
HA2.0
HA2.7
HA3.5
HA3.5; HA4.0;
HB4.0
HA4.5
HA5.0
HB6.5
The b and t values in Table B.1 are related to the thickness of the plate. If the thickness of the bone plate is greater than aref, in order not to weaken the plate
Yes, the value of t should not exceed the requirements of Table B.1, and the value of b should be increased. If the thickness of the bone plate is smaller than aref, in order to prevent the screw head from the bone
On the board, the value of b should not be less than that specified in Table B.1, and the value of t can be reduced or even approached to zero.
The above comments can be explained by the following mathematical formula.
When a≥aref, t=t1,
When a \u003caref,t=t1-(aref-a),
When a≤aref, b=b1,
When a >aref, b=b1 (a-aref),
Where aref, t1, and b1 take the values of a, t, and b in Table B.1.
B.2 Type B (tapered hole)
Figure B.2 B-type hole with HB6.5 screw according to YY 0018
B.3 Type C (threaded hole)
Figure B.3 C-type hole with the HB6.5 screw according to YY 0018
Table B.2 Dimensions of the C-type holes are in millimeters
D1 d2
Dimensional tolerance dimensional tolerance
Minimum value
The cylindrical part of the counterbore (depending on a)
Dimensional tolerance
Aref
4.7
5.5
0.2
0 8.2
0.2
0.35
0.75
1.4 0-0.2 3.5
B.4 D type (spherical counterbore)
Figure B.4 D1 hole
Figure B.5 D2 hole
Figure B.6 D3 hole
Table B.3 Dimensions of D1, D2 and D3 holes are in millimeters
D1 re
Dimensional tolerance dimensional tolerance tolerance tolerance
Minimum value
Screw in YY 0018
1.6
1.9
2.1
2.6
2.9
3.4
3.7
4.2
4.7a
5.5a
5.2a
5.9a
6.6b
0.2
1.5
2.0
2.5
3.0
4.0
0.075
0.050
0.1
0.2
0.4
0.15
0.2
0.4
0.5
HA1.5
HA2.0
HA2.7
HA3.5
HA3.5; HA4.0;
HB4.0
HA4.5; HB6.5
HA4.5; HA5.0;
HB6.5
HB6.5
a In order to pass the screw of HB6.5, the diameter d1 can be made threaded.
b This value can only be used in special cases.
B.5 Holes and slots for fitting with HC screws
Figure B.7 Hole with the HC screw
Figure B.8 Slot with HC screw
Table B.4 Hole and groove dimensions in mm with the HC screw are in millimeters
Dimensional tolerance
Screw in YY 0018
3.0
4.3
0.1
HC2.9
HC3.5
HC3.9
HC4.2
B.6 Holes and slots for mating with HD screws
Figure B.9 Holes with HD screws
Figure B.10 Slots mated with HD screws
Table B.5 Holes and groove dimensions in mm with the HD screw are in millimeters
Dimensional tolerance
Screw in YY 0018
4.4
5.5
0.1
HD4.0
HD4.5
Appendix C
(informative appendix)
List of approved method standards for chemical analysis
ASTME 1479-11 Inductively coupled plasma spectrometer description and specified standard procedures (Standard Practice for De-
scribingandSpecifyingInductively-CoupledPlasmaAtomicEmissionSpectrometers)
ASTME 1019-11 Standard Test Method for Determination of Carbon, Sulfur, Nitrogen and Oxygen Content in Steel, Iron, Nickel and Cobalt Alloys (StandardTest)
MethodsforDeterminationofCarbon,Sulfur,Nitrogen,andOxygeninSteelandinIron,Nickel,
andCobaltAloys)
ASTME1447-09 Standard Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal Conduction/Infrared Detection
(StandardTestMethodforDeterminationofHydrogeninTitaniumandTitaniumAloysbytheInert
GasFusionThermalConductivity/InfraredDetectionMethod)
ASTME1409-08 Standard Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Melting Technique (StandardTest)
MethodforDeterminationofOxygenandNitrogeninTitaniumandTitaniumAloysbytheInertGas
FusionTechnique)
references
[1] ASTMF382 StandardSpecification and TestMethodforMetalicBonePlates.
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