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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0018-2016: Implants for osteosynthesis - Metallic bone screws Status: Valid YY 0018: Historical versions
Basic dataStandard 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11.040.40 Word Count Estimation: 23,231 Date of Issue: 1990-01-01 Date of Implementation: 2018-06-01 Older Standard (superseded by this standard): YY 0018-2008 Quoted Standard: GB 4234; GB/T 4340.1; GB/T 10610; GB/T 13810; GB/T 16886.5; GB 23102; YY/T 1074; YY 0341; YY/T 0343; YY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 ContentForeword 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 19ForewordThe 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 screw1 ScopeThis 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 referencesThe 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 definitionsThe 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 classification4.1 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 requirements5.1 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 A......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 0018-2016_English be delivered?Answer: Upon your order, we will start to translate YY 0018-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. 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