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YY 0018-2016: Implants for osteosynthesis - Metallic bone screws
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Implants for osteosynthesis - Metallic bone screws
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PDF similar to YY 0018-2016
Basic data | Standard ID | YY 0018-2016 (YY0018-2016) | | Description (Translated English) | Implants for osteosynthesis - Metallic bone screws | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 23,231 | | Date of Issue | 1990-01-01 | | Date of Implementation | 2018-06-01 | | Older Standard (superseded by this standard) | YY 0018-2008 | | Quoted Standard | GB 4234; GB/T 4340.1; GB/T 10610; GB/T 13810; GB/T 16886.5; GB 23102; YY/T 1074; YY 0341; YY/T 0343; YY 0605.9; YY/T 0640; YY/T 0662; YY/T 1504; YY/T 1505; YY/T 1506; ISO 5835; ISO 9268 | | 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 terminology and definitions, classification, requirements, test methods, manufacture, sterilization, packaging, and information provided by the manufacturer of bone graft implants - metallic bone screws. This standard applies to metal bone screws (hereinafter referred to as "bone screw"), the product for orthopedic surgery for fracture fixation. But this standard does not include the spine and specially designed bone screws. | YY 0018-2016: Implants for osteosynthesis - Metallic bone screws---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 screws
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0018-2008
Bone joint implant metal bone screw
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 Category 3
5 Requirements 11
6 Test method 13
7 Manufacturing 14
8 sterilization 14
9 Packing 14
10 Information provided by the manufacturer 14
Appendix A (informative) The significance of each parameter in the mechanical performance requirements of this standard 15
Appendix B (informative) List of approved method standards for chemical analysis 16
Appendix C (informative) List of approved method standards for metallographic examinations 17
Appendix D (Normative) Description of the method for determining the maximum torque and fracture torsion angle 18
Reference 19
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 0018-2008 "Bone-joined implant metal bone screw", compared with YY 0018-2008, the main technology
The differences are as follows.
--- Added terms and definitions (see Chapter 3);
--- Removed the product model example (3.1 of the.2008 version), the type and code of each part (3.2 of the.2008 version);
--- Classification of bone screws in accordance with international standards ISO 5835 and ISO 9268 (see Chapter 4);
--- "Maximum torque and fracture torsion angle" increased the number of test samples and re-test requirements (see 5.2.1), the test method has been added
A detailed description of the definition of the fracture (see Appendix A);
--- Increased axial pull-out force requirements (see 5.2.3);
--- Increased screwing torque and screwing out torque requirements (see 5.2.4);
--- Increased the requirement for self-tapping performance (see 5.2.5);
--- "Surface roughness" added "the surface roughness of the bone screw for special surface treatment (such as sand blasting) can be based on the manufacturer
Notes on the development of relevant requirements for clinical needs (see 5.4.2);
--- Added provisions for surface treatment, specifying the relevant content for evaluation of anodized surface treatment products (see 5.4.4);
--- "Dimensions" added the head diameter d2 (see 5.5);
--- Deleted the contents of the "inspection rules" (Chapter 6 of the.2008 edition);
--- Added provisions for "manufacturing" and "sterilization" (see Chapters 7, 8);
--- Added Appendix A, Appendix C and Appendix D. The.2008 edition of Appendix A is adjusted to Appendix B.
This standard is in accordance with the basic requirements of YY 0341-2009 "General technical conditions for passive surgical metal implants for bone joining", and reference
ASTMF543 "Standard Specification and Test Method for Medical Metal Bone Screws", YY 0018-2008 "Bone Joint Implantation"
The metal bone screw was revised. In this standard, HA and HB type bone screws and size reference are adopted in ISO 5835.1991.
Implant with hexagonal drive connection, spherical lower surface head and asymmetric threaded metal bone screw size; HC, HD
Type bone screw and size reference using ISO 9268.1988 "Surgical implant cone lower surface head metal bone screw
Inch".
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 was proposed by the State Food and Drug Administration.
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. Zhang Chen, Fu Ruizhi, Zhang Wenhui, Song Wei, Liu Yinghui, Dong Wenxing.
This standard replaces YY 0018-2008.
The previous versions of YY 0018-2008 are released as follows.
---YY 0018-1990, YY 0018-2002.
Bone joint implant metal bone screw
1 Scope
This standard specifies the terms and definitions, classification, requirements, test methods, manufacturing, sterilization, and packaging of bone-engaged implants--metal bone screws.
Information provided by the manufacturer and manufacturer.
This standard applies to metal bone screws (hereinafter referred to as "bone screws"), which is used for internal fixation of fractures during orthopedic surgery. But this
The standard does not include spine and specially designed bone screws.
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/T 1074 surgical implant stainless steel product pitting potential
YY 0341 General technical requirements for passive surgical metal implants for bone cementation
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 0662 Surgical implants - Asymmetric threads and spherical
YY/T 1504 surgical implant metal bone screw axial pull-out force test method
YY/T 1505 surgical implant metal bone screw self-tapping performance test method
YY/T 1506 Surgical Implant Metal Bone Screw Rotation Torque Test Method
ISO 5835 surgical implant with hexagonal drive connection, spherical lower surface head and asymmetrical threaded metal bone screws
Size (Implantsforsurgery-Metalbonescrewswithhexagonaldriveconnection,sphericalunder-sur-
Faceofhead,asymmetricalthread-Dimensions)
ISO 9268 Surgical Implants Conical lower surface head metal bone screw size (Implantsforsurgery-Metal
bonescrewswithconicalunder-surfaceofhead-Dimensions)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Screw thread screwthread
Spiral groove on the surface of a cylinder or cone. The protruding spiral ridges are called threads, including the top and bottom.
3.2
Serrated thread buttressthread
An asymmetrical thread profile characterized by a pressure flank that is approximately perpendicular to the axis of the thread.
3.3
Screw head screwhead
The other end opposite the end of the screw is used in conjunction with a tool for screwing in the screw.
3.4
Screw length screwlength
The entire measured length from the head of the screw to the end of the screw.
3.5
Pitch pitch
The distance from the top of the adjacent thread.
3.6
Bottom diameter corediameter
The smallest diameter of the screw thread portion measured from the root of the thread. Also known as small diameter or root diameter.
3.7
Thread diameter threaddiameter
The maximum diameter of the screw thread portion measured from the top of the thread, also known as the maximum diameter.
3.8
Thread length threadlength
The length of the threaded portion of the screw is measured from the undercut to the end of the screw.
3.9
Backflush threadrunout
The portion where the threaded portion of the screw intersects the head of the screw or screw.
3.10
Size size
The indication of the nominal thread diameter of the screw.
3.11
Pilot hole pilothole
A hole drilled in the bone into which the screw end is screwed. The pilot hole is usually slightly larger than the screw bottom diameter. If the screw is used for osteotomy, then guide
A portion of the hole may be larger to provide a clearance fit.
3.12
Solid core solidcore
A screw that does not include a hollow tube along the longitudinal axis.
3.13
Cancellous bone screw cancelousscrew
A screw that is primarily used to implant cancellous bone. Cancellous bone screws usually have HB-type threads, either full or not.
3.14
Cortical screw corticalscrew
A screw that is primarily used to implant cortical bone. Cortical bone screws typically have an HA-type thread and are fully threaded.
3.15
Non-tapping screw nontappingscrew
A screw with no flutes at the end. When used for medium or hard bones, non-self-tapping screws usually require a tap to guide the screw before it is screwed in.
Into the hole.
3.16
Self-tapping screw self-tappingscrew
A screw with a plurality of flutes at the end for tapping the thread shape in the bone when screwed in.
3.17
Partially threaded screw partialythreadedscrew
A screw whose threaded portion does not completely cover from the end of the screw to the head of the screw, but with a smooth stem between them.
3.18
Gauge length
The distance from the fixture (such as the collet) to the bottom of the screw head.
3.19
Grip length
The length of the thread that is fastened in the fixture or other device.
3.20
Maximum torque maximumtorque
The maximum torque recorded before the torsional shear fracture of the screw, in Newtons meters (N·m).
3.21
Break twist angle breakingangle
The angle of rotation when the screw torsion fails is shown as a rapid decrease in indicated torque.
3.22
Axial pullout force axialpuloutstrength
Pull the bone screw out of the screwed material or pull it out to the tensile force required for its damage in Newtons (N).
3.23
Screw in depth insertiondepth
Screw the depth of the thread segment into the test material.
3.24
Screw in torque insertiontorque
The torque required to overcome the friction between the screw and the test material when screwing the screw into the test material.
3.25
Unscrew the torque removaltorque
The torque required to overcome the friction between the screw and the test material when the screw is screwed out of the test material (for example, the right-handed thread is reversed)
Rotate in the hour hand direction).
3.26
Self-tapping force
The value of the axial force required for self-tapping screws of self-tapping type, in Newtons (N).
3.27
Torsional yield strength torsionalyieldstrength
The ratio limit reached by the screw in Newton meters (N·m). The translation method was used for the measurement, and the amount of translation was 2°.
4 classification
4.1 bone screw type
There are many different types of bone screws, as shown in Table 1. The specific description is as follows.
---HA type, the lower surface of the screw head is spherical, with shallow zigzag asymmetric threads;
---HB type, the lower surface of the screw head is spherical, with a deep zigzag asymmetric thread;
---HC type, the lower surface of the screw head is tapered and has a symmetrical thread;
---HD type, the lower surface of the screw head is tapered and has an asymmetrical thread.
Note. Special structures or special specifications are specified by the manufacturer according to clinical needs.
Table 1 Types of bone screws
Bone screw
Thread type
HA type HB type HC type HD type
Screw head
Lower surface
Spherical cone
Drive connection
inner hexagon
One-slot groove cross groove cross groove head
Composite drive connection
One-slot composite cross groove composite
Cross recessed head cross recessed head
4.2 HA type bone screw
The HA type bone screw is shown in Figure 1, and its dimensions are shown in Table 2.
a For self-tapping screws, the angle can be 60°.
Figure 1 HA type bone screw
Table 2 HA type bone screw is in millimeters
Type and screw
Grain diameter
Nominal diameter
D1
D2
Nominal tolerance
R1
0.25
R2
R3
SW
F10a
Minimum value
HA1.5 1.5 3
HA2.0 2.0 4
-0.10
1.6 1.5 1.5 0.3 1.5 0.8
1.9 2.0 2.0 0.4 1.5 1.0
HA2.7 2.7 5
HA3.5 3.5 6
HA4.0 4.0 6
HA4.5 4.5 8
HA5.0 5.0 8
-0.15
2.3 2.5 2.5 0.4 2.5 1.2
2.6 3.0 2.5 1.0 2.5 1.5
2.4 3.0 2.5 1.0 2.5 1.5
4.6 4.0 2.5 1.0 3.5 2.8
4.6 4.0 2.5 1.0 3.5 2.8
a tolerance F10=
0.047
0.007{, when SW≤3mm; tolerance F10=
0.058
0.010{, when SW >3mm.
4.3 HA type bone screw thread
The HA type bone screw thread is shown in Figure 2, and its dimensions are shown in Table 3.
Figure 2 Shallow thread (HA type)
Table 3 Size of HA type thread
Type and screw
Grain diameter
D1/mm d5/mm
Nominal value tolerance nominal tolerance
e/mm
P/mm
R4/mm
R5/mm
//°
//°
HA1.5 1.5
HA2.0 2.0
HA2.7 2.7
HA3.5 3.5
HA4.0 4.0
HA4.5 4.5
HA5.0 5.0
-0.15
1.1
1.3
1.9
2.4
2.9
3.0
3.5
-0.10
-0.15
0.1 0.50 0.3 0.1 35 3
0.1 0.60 0.4 0.1 35 3
0.1 1.00 0.6 0.2 35 3
0.1 1.25 0.8 0.2 35 3
0.1 1.50a, b 0.8 0.2 35 3
0.1 1.75 1.0 0.3 35 3
0.1 1.75 1.0 0.3 35 3
a Thread type tolerance.
All parameter values d1, d5, e, P, r4, r5, α and β can be used to define their theoretical maximum thread profile.
It is recommended that the maximum allowable deviation of the theoretical tooth at any point of the thread should not exceed.
---HA1.5 and HA2.0 bone screw, 0.050mm;
---HA2.7 and HA5.0 bone screw, 0.075mm.
b Note. The pitch of the HA4.0 bone screw is 1.50 mm, and the pitch of the HB4.0 bone screw is 1.75 mm (see Table 5).
4.4 HB type bone screw
The HB type bone screw is shown in Figure 3, and its dimensions are shown in Table 4.
Figure 3 HB bone screw
Table 4 HB type bone screw is in millimeters
Type and screw
Grain diameter
Nominal diameter
D1
D2 d4
Nominal value tolerance nominal tolerance
R1
0.25
R2
SW
F10a
Minimum value
HB4.0 4.0 6
HB6.5 6.5 8
-0.15
2.4
4.5
-0.15
2.9 3 2.5 2.5 1.5
4.6 4 2.5 3.5 2.8
a tolerance F10=
0.047
0.007{, when SW≤3mm; tolerance F10=
0.058
0.010{, when SW >3mm.
4.5 HB bone screw thread
The HB type bone screw thread is shown in Figure 4, and its dimensions are shown in Table 5.
Figure 4 deep thread (HB type)
Table 5 Size of HB thread
Type and screw
Grain diameter
D1/mm d5/mm e/mm
Nominal value tolerance nominal tolerance ≈
P/mm
R4/mm r5/mm α/° β/°
≈ ≈ ≈ ≈
HB4.0 4.0
HB6.5 6.5
-0.15
1.9
3.0
-0.15
0.1 1.75a, b 0.8 0.3 25 5
0.2 2.75 1.2 0.8 25 5
a Note. The pitch of the HA4.0 bone screw is 1.5mm, and the pitch of the HB4.0 bone screw is 1.75mm.
b Thread type tolerance.
All parameter values d1, d5, e, r4, r5, α and β can be used to define the theoretical maximum thread profile.
It is recommended that the maximum allowable deviation of the theoretical tooth at any point of the thread should not exceed.
---HB bone screw, 0.075mm.
These data may need to be reconfirmed when revised.
4.6 HC type bone screw
4.6.1 HC-type bone screw with drive connection as a slot
The HC-type bone screw that drives the connection as a slot is shown in Figure 5, and its dimensions are shown in Table 6.
Figure 5 HC-type bone screw with drive connection as a slot
Table 6 HC-type bone screw dimensions for driving the connection to a slot
Thread type
Nominal diameter
D1/mm
D2/mm g/mm h/mm r2/mm
x/mm
Maximum
//°
HC 2.9 4.62~6.10 1.25~1.40 1.5~2.0 5 1.6
Optional. for example
≥60°
4.6.2 HC-type bone screw with drive cross connection
The HC-type bone screw that drives the connection to the cross recess is shown in Figure 6, and its dimensions are shown in Table 7.
Figure 6 HC-type bone screw with drive cross-section
Table 7 HC-type bone screw dimensions for driving the connection to the cross recess
Thread type
Nominal diameter
D1/mm
D2/mm g/mm h/mm r2/mm
x/mm
Maximum
//°
HC
3.5
3.9
4.2
5.8~6.5 1.25~1.40 1.5~2.0 6.35 1.6
Optional. for example
≥60°
4.7 HC type bone screw thread
The HC type bone screw thread is shown in Figure 7, and its dimensions are shown in Table 8.
Figure 7 HC type bone screw thread
Table 8 HC type bone screw thread size unit is mm
Type and
Thread diameter
D1 d5
Minimum value, maximum value, minimum value
Maximum
HC2.9 2.79 2.90 2.03 2.18 1.06
HC3.5 3.43 3.53 2.51 2.64
HC3.9 3.78 3.91 2.77 2.92
HC4.2 4.09 4.22 2.95 3.25
1.27
0.1
Note. It is possible to add a suitable flute to make the screw self-tapping.
4.8 HD bone screw
The HD type bone screw is shown in Figure 8, and the dimensions are shown in Table 9.
Figure 8 HD-type bone screw with drive cross-section
Table 9 HD-type bone screw size with drive cross-section
Thread type
Nominal diameter
D1/mm
D2/mm g/mm
x/mm
Maximum
h/mm α/°
HD
4.0
4.5
6.75~7.35 1.25~1.40 1.6 1.8~2.1
Optional. for example
≥60°
4.9 HD type bone screw thread
The HD type bone screw thread is shown in Figure 9, and the dimensions are shown in Table 10.
Figure 9 HD type bone screw thread
Table 10 HD type bone screw thread size
Type and screw
Grain diameter
D1/mm d5/mm
Nominal value tolerance nominal tolerance
e/mm P/mm γ/° β/°
HD4.0 4.0
HD4.5 4.5
±0.03 2.92 ±0.03 0.1
1.59
2.18
Note. It is possible to add a suitable flute to make the screw self-tapping.
5 requirements
5.1 Materials
Surgical implant materials specified in international standards, national standards, and industry standards should be preferred for bone screws.
The materials selected for the bone screw include, but are not limited to, the following materials. stainless steel bone screws should preferably be used in accordance with GB 4234 or
Materials specified in YY 0605.9; titanium alloy bone screws should preferably be selected in accordance with GB/T 13810 or GB 23102.
5.2 Mechanical properties
5.2.1 Maximum torque and fracture torsion angle
Different thread type and nominal diameter spherical lower surface bone screws made of stainless steel material specified in GB 4234, max.
The torque and breaking torsion angle shall be in accordance with Table 11. The number of test samples shall not be less than 5; the manufacturer shall deal with the maximum of other bone screws.
Torque and breaking torsion angle are specified.
Table 11 Maximum torque and fracture torsion angle
Thread type and nominal diameter maximum torque/N · m breaking torsion angle/°
HA1.5 ≥0.2 ≥150
HA2.0 ≥0.35 ≥150
HA2.7 ≥1.0 ≥180
HA3.5 ≥2.3 ≥180
HA4.0 ≥4.0 ≥180
HA4.5 ≥4.4 ≥180
HA5.0 ≥5.5 ≥180
HB4.0 ≥1.3 ≥90
HB6.5 ≥6.2 ≥90
Note. The manufacturer can refer to this table to specify the maximum torque and fracture torsion angle of other bone screws.
5.2.2 Hardness
The hardness of the bone screw should meet the requirements of Table 12. Bone screws made of stainless steel material specified in GB 4234, if
As specified in Table 11, the hardness may not be detected.
Table 12 hardness
Material hardness/HV10
Stainless steel ≥210
Titanium alloy ≥260
5.2.3 Axial pull-out force
Manufacturers should specify the axial pull-out force of the bone screw.
5.2.4 Screw-in torque and screw-out torque
Manufacturers should specify the screwing torque and the screwing torque of the bone screw.
5.2.5 Self-tapping performance
Manufacturers should specify the self-tapping performance of self-tapping screws.
Note. The maximum torque, fracture torsion angle, axial pull-out force, screwing torque, screwing torque and self-tapping performance of the mechanical performance requirements are given in Appendix A.
The significance of it.
5.3 Corrosion resistance
The pitting potential (Eb) of the stainless steel bone screw should be not less than 800 mV.
5.4 Surface quality
5.4.1 Surface defects
The surface of the bone screw must not have discontinuous defects.
5.4.2 Surface roughness
The surface roughness Ra of the bone screw should not be greater than that specified in Table 13.
Table 13 Surface roughness in microns
Material type nail head outer surface thread rest
Stainless steel 0.4
Titanium alloy 0.8
3.2 1.6
Note. The surface roughness of bone screws for special surface treatments (eg sandblasting) can be set by the manufacturer according to clinical needs.
5.4.3 Appearance
The surface of the bone screw should be free of scale, knife marks, small gaps, scratches, cracks, dents, sharp edges (except for the edge), burrs, etc.
Inlays, finishing deposits and other contaminants.
5.4.4 Surface treatment
After the anodized surface of the bone screw product, the product should be qualitatively analyzed for surface elements and evaluated for cytotoxicity.
5.5 size
5.5.1 The maximum diameter d1 of the bone screw, the bottom diameter d5, and the head diameter d2 shall comply with Table 2~Table 10 or ISO 5835, ISO 9268.
Provisions.
5.5.2 The dimensions and tolerances of special series of bone screws are determined by the manufacturer according to clinical needs.
6 Test methods
6.1 Materials
Chemical composition and microstructure should be sampled on the final product, according to the method specified in the selected material standard or the recommended method in Appendix B and Appendix C.
The law is tested.
6.2 Mechanical properties
6.2.1 Maximum torque and fracture torsion angle
According to the method specified in YY/T 0662, it is recommended to use a fixed angular velocity of 3r/min to rotate the bone screw into the bone.
The screw broke and recorded the maximum torque and the torsion angle of the fracture.
Note 1. If the torsion test is performed by an electronic torsion tester, the range should be selected to ensure that the maximum torque and fracture torsion angle recorded are within the effective measurement range of the test machine.
within;
Note 2. When possible, there should be 5 complete thread exposures from the thread near the head of the screw. If less than 5 complete exposures, please indicate in the report.
Note 3. Maximum torque and fracture torsion angle are determined according to the method in Appendix D.
6.2.2 Hardness
According to the method specified in GB/T 4340.1, measure 3 points in the longitudinal section of the rod, take the arithmetic mean of 3 points, and the number of samples.
It is 3 pieces.
6.2.3 Axial pull-out force
Follow the method specified in YY/T 1504.
6.2.4 Screw-in torque and screw-out torque
Follow the method specified in YY/T 1506.
6.2.5 Self-tapping performance
Follow the method specified in YY/T 1505.
6.3 Corrosion resistance
According to the method specified in YY/T 1074, the number of samples is 3.
6.4 Surface quality
6.4.1 Surface defects
According to YY/T 0343, the number of samples is 3 pieces.
6.4.2 Surface roughness
The test is carried out by using the sample comparison method or the electrical measurement method, and the electrical measurement method is an arbitration test method. When using the electrical test method, it should be in accordance with GB/T 10610
The regulations are carried out and the number of samples is 3 pieces.
6.4.3 Appearance
According to the method specified in YY 0341, the number of samples is 10.
6.4.4 Surface treatment
Qualitative analysis of surface elements was carried out by scanning electron microscopy.
Cytotoxicity was tested in accordance with the provisions of GB/T 16886.5.
6.5 size
Measured with a universal gage or a dedicated gage, the number of samples is 10.
7 manufacturing
Should comply with the provisions of YY/T 0640.
8 sterilization
Should comply with the provisions of YY/T 0640.
9 packaging
Should comply with the provisions of YY/T 0640.
10 Information provided by the manufacturer
10.1 Label
Should comply with the provisions of YY/T 0640.
10.2 mark
Should comply with the provisions of YY/T 0640. Where size permits, the information should be clearly marked on the head of the screw.
10.3 User's Manual
Should comply with the provisions of YY/T 0640.
Appendix A
(informative appendix)
This standard.
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