Titanium alloy bar quality detection method and system

Abstract

The application discloses a titanium alloy bar quality detection method and system, relates to the titanium alloy material quality detection technical field, and meets the requirements of YY0117.1-2005 and NMPA, and the single detection time is less than or equal to 30s, is suitable for batch production, and guarantees the clinical safety of artificial joint blanks.

Description

Technical Field

[0001] This invention relates to the field of titanium alloy material quality testing technology, and in particular to a method and system for testing the quality of titanium alloy bars. Background Technology

[0002] Artificial joints, as Class III medical devices implanted in the human body, are mostly made of α-type titanium alloy as their core blank. This alloy has excellent biocompatibility and meets the basic requirements of GB / T13810-2017 "Titanium and Titanium Alloy Processed Materials for Surgical Implants". In order to improve the bone integration ability, the surface of the blank is usually coated with hydroxyapatite coating. The coating performance must meet the adhesion and porosity requirements in YY0117.1-2005 "Surgical Implants - Forgings and Castings of Bone and Joint Prostheses".

[0003] According to NMPA registration requirements, artificial joint blanks must undergo multi-dimensional testing: surface defect detection, with a focus on penetrating scratches; internal integrity testing, to identify microcracks at the 0.1mm level; physicochemical performance testing, covering mechanical properties under a 37℃ body fluid environment, simulated body fluid corrosion rate and ppb-level harmful elements; and data traceability, to achieve full life-cycle information traceability for a single blank.

[0004] Existing detection technologies have significant shortcomings:

[0005] Insufficient accuracy in surface defect detection: Conventional visual inspection cannot distinguish whether scratches penetrate the coating, and eddy current detection is affected by coating interference with a signal rate of over 30%, resulting in a high false positive rate for penetrating scratches;

[0006] High failure rate of internal cracks: The anisotropy of α-type titanium alloy causes distortion of ultrasonic testing (UT) signals, resulting in a failure rate of up to 25% for cracks in the central area below 0.5 mm, which cannot meet the YY0117.1-2005 AA grade flaw detection standard.

[0007] The physical and chemical tests are out of touch with medical applications: mechanical tests are mostly conducted at room temperature, corrosion tests use industrial salt spray, and the detection limit for harmful elements is only 0.01 ppm, which does not meet the ppb level requirements for medical applications.

[0008] Lack of data traceability: Data from various testing devices is isolated, and 30% of enterprises use paper records, which cannot meet the NMPA's mandatory requirement for full-process traceability.

[0009] In summary, existing technologies cannot meet the high-precision, scenario-based, and compliant testing requirements of coated α-type titanium alloy artificial joint blanks, and an integrated testing solution is urgently needed. Summary of the Invention

[0010] The purpose of this invention is to at least solve one of the technical problems existing in the prior art, and to provide a method and system for quality inspection of titanium alloy bars, which can solve the problem of a method and system for quality inspection of titanium alloy bars.

[0011] To achieve the above objectives, the present invention provides the following technical solution: a method for quality inspection of titanium alloy bars, comprising the following steps:

[0012] S1: The billet is fed and associated with the UID. The servo robotic arm grabs the billet, the UID coding unit generates a unique QR code, and the fourth control unit uploads it to the cloud management unit.

[0013] S2: Surface defect detection, through a three-level process of visual screening, thickness correlation judgment and microscopic confirmation, to identify penetrating scratches;

[0014] S3: Internal integrity inspection, which uses dual-frequency ultrasonic scanning and thermal imaging to determine the size and location of internal cracks;

[0015] S4: Medical-grade physical and chemical performance sampling test, testing mechanical properties, simulated body fluid corrosion rate and ppb level harmful elements in a 37℃ body fluid environment;

[0016] S5: Data integration and judgment. The fourth control unit summarizes the test data and determines whether the billet is qualified.

[0017] S6: Report output and traceability. The cloud management unit generates standardized test reports and associates them with UIDs to achieve full-process traceability.

[0018] Preferably, in step S2, the triggering condition for the thickness correlation determination is: the coating thickness H1 of the suspected area collected by the laser thickness detection unit and the coating thickness H2 of the defect-free area satisfy |H1-H2|>90%×coating design thickness;

[0019] The microscopic confirmation is achieved by observing the cross-section of the scratch using SEM and detecting the percentage of coating elements using EDS energy dispersive spectroscopy. If the percentage of coating elements is less than 5%, it is determined to be a penetrating scratch.

[0020] Preferably, in step S3, the condition for determining the internal crack is: the amplitude of the ultrasonic signal exceeds three times the standard deviation of the reference value, and the thermal imager captures a temperature anomaly point with a temperature difference greater than 0.5℃.

[0021] The benchmark value is calibrated using a defect-free standard sample.

[0022] Preferably, in step S4, the mechanical performance qualification standard is: tensile strength of TA2 material billet ≥ 485 MPa, yield strength ≥ 345 MPa;

[0023] The acceptable corrosion rate standard is Vcorr≤0.005mm / year;

[0024] The acceptable standards for harmful elements are Pb≤0.001ppm, Hg≤0.001ppm, and Cd≤0.002ppm.

[0025] Preferably, the time for single billet testing in steps S2-S3 is ≤30s, the sampling ratio in step S4 is 3 billets per batch, and the physical and chemical testing cycle is ≤24h.

[0026] Preferably, in step S6, the standardized test report includes the test standard number, screenshot of the original data, and qualification judgment, which complies with the "Requirements for Self-Inspection Report for Medical Device Registration" and supports mobile scanning or PC query and traceability.

[0027] A quality inspection system for titanium alloy bars includes a surface defect detection module, an internal integrity detection module, a medical-grade physicochemical property testing module, and an Internet of Things data traceability module;

[0028] The surface defect detection module includes a high-resolution vision unit, a laser thickness detection unit, a microscopic verification unit, and a first control unit, wherein the first control unit is equipped with a convolutional neural network defect recognition model.

[0029] The internal integrity detection module includes a dual-frequency focusing ultrasound unit, an ultrasound signal processing unit, a thermal imaging complementary unit, and a second control unit. The ultrasound signal processing unit integrates an FPGA chip and an adaptive acoustic impedance compensation algorithm.

[0030] The medical-grade physicochemical performance testing module includes a constant temperature body fluid dynamics unit, a simulated body fluid corrosion unit, an ultra-trace element detection unit, and a third control unit. The constant temperature body fluid dynamics unit has a built-in 37℃±0.5℃ environmental simulation chamber and an ISO10993-5 standard simulated body fluid circulation device.

[0031] The Internet of Things (IoT) data traceability module includes a UID coding unit, a data acquisition unit, a cloud management unit, and a fourth control unit. The data storage period of the cloud management unit is ≥5 years.

[0032] The modules are connected via the Profinet industrial bus to enable real-time data interaction.

[0033] Preferably, the dual-frequency focusing ultrasound unit is a 10MHz high-frequency + 5MHz low-frequency composite probe, using water immersion coupling with deionized water as the coupling agent; the thermal imaging complementary unit is an eddy current thermal imager with a detection resolution ≤10μm.

[0034] Preferably, the ultra-trace element detection unit is a high-resolution inductively coupled plasma mass spectrometer with a resolution ≥10000 and a detection limit ≤0.001ppm for Pb and Hg; the simulated body fluid corrosion unit adopts potentiodynamic polarization method with a scanning voltage range of -1.5~1.5V and a scanning rate of 1mV / s.

[0035] Preferably, the UID coding unit is a laser coding machine with a coding depth of ≤0.02mm, and the generated unique QR code contains the batch number, specifications and production time information of the blank.

[0036] Compared with the prior art, the beneficial effects of the present invention are:

[0037] 1. The quality inspection method and system for titanium alloy bars identifies coating penetrating scratches through a three-level judgment system of visual, laser thickness, and microscopic analysis. It combines dual-frequency ultrasound and thermal imaging to complementarily correct signal distortion in α-type titanium alloys, resulting in a near-surface crack miss rate of ≤5% at the 0.1mm level. This meets the YY0117.1-2005 AA-level flaw detection standard and effectively avoids the risks of inflammation caused by coating damage and implantation fracture caused by internal cracks.

[0038] 2. The quality inspection method and system for this titanium alloy rod simulates the in vivo state in a constant temperature body fluid environment of 37℃, reducing the mechanical test deviation to ≤2%; it adopts the ISO10993-5 standard to simulate the corrosion rate of body fluid, and raises the detection limit of harmful elements such as Pb and Hg to 0.001ppm (ppb level) through HR-ICP-MS, eliminating biosafety risks such as metal ion release and corrosion failure, and meeting the stringent requirements for medical implants.

[0039] 3. The quality inspection method and system for titanium alloy bars achieves full-process data binding for a single billet through UID coding, and generates standardized reports in the cloud that meet NMPA requirements, satisfying traceability and auditability compliance needs; at the same time, the time for surface and internal inspection of a single bar is ≤30s, the sampling cycle for physicochemical testing is ≤24h, and it is suitable for batch production of 100,000 bars / month, balancing inspection quality and production efficiency. Attached Figure Description

[0040] The present invention will be further described below with reference to the accompanying drawings and embodiments:

[0041] Figure 1 This is a schematic block diagram of a titanium alloy bar quality inspection system according to the present invention. Detailed Implementation

[0042] This section will describe in detail specific embodiments of the present invention. Preferred embodiments of the present invention are shown in the accompanying drawings. The purpose of the drawings is to supplement the textual description with graphics, so that people can intuitively and vividly understand each technical feature and overall technical solution of the present invention, but they should not be construed as limiting the scope of protection of the present invention.

[0043] In the description of this invention, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc., are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0044] In the description of this invention, terms such as greater than, less than, and exceeding are understood to exclude the stated number, while terms such as above, below, and within are understood to include the stated number. The use of "first" and "second" in the description is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0045] In the description of this invention, unless otherwise explicitly defined, terms such as "set up," "install," and "connect" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this invention in conjunction with the specific content of the technical solution.

[0046] This invention provides a technical solution: a method for quality inspection of titanium alloy bars, comprising the following steps:

[0047] S1: The billet loading is associated with the UID. The servo robotic arm grabs the coated α-type titanium alloy artificial joint billet. The UID coding unit generates a unique QR code and marks it on the end face of the billet. The fourth control unit reads the UID and uploads it to the cloud management unit.

[0048] S2: Surface defect detection:

[0049] S21: Visual screening, high-resolution vision unit acquires images of the billet surface, first control unit identifies the location and length of scratches through CNN model, and marks suspected penetration areas;

[0050] S22: Thickness correlation judgment. The laser thickness detection unit collects the coating thickness of the suspected area (H1) and the defect-free area (H2). If |H1-H2|>90%×coating design thickness, microscopic verification is triggered. Microscopic confirmation is achieved by observing the scratch cross section through SEM and detecting the coating element ratio through EDS energy dispersive spectroscopy. If the coating element ratio is <5%, it is judged as a penetrating scratch.

[0051] S23: Microscopic confirmation: If the coating element content is <5%, it is judged as a penetrating scratch; otherwise, it is a non-penetrating defect.

[0052] S3: Internal Integrity Check

[0053] S31: Parameter calibration, the second control unit presets the ultrasonic probe focal length and thermal imager excitation power according to the billet diameter and coating thickness;

[0054] S32: Full-range scanning, servo drive system drives billet spiral feed, dual-frequency ultrasonic probe rotates 360° to scan (collecting 20 data points every 1mm), thermal imager scans simultaneously;

[0055] S33: Defect judgment: If the ultrasonic signal amplitude exceeds 3 times the standard deviation of the reference value and the thermal imager captures a temperature anomaly point with a temperature difference of >0.5℃, it is judged as an internal crack and recorded according to size (0.1-0.3mm / 0.3-0.5mm / >0.5mm);

[0056] S4: Medical-grade physical and chemical performance sampling test, three blanks are randomly selected from each batch, controlled by the third control unit:

[0057] S41: Isothermal fluid dynamics test, tensile test is carried out in a simulated body fluid environment at 37℃, and tensile strength and yield strength are collected;

[0058] S42: Simulated body fluid corrosion test, the blank is processed into Φ5mm×20mm specimens (3 specimens with coating retained / 3 specimens with damage), and the corrosion rate Vcorr is tested to be ≤0.005mm / year;

[0059] S43: Ultra-trace element detection, detected by HR-ICP-MS, ensuring Pb≤0.001ppm, Hg≤0.001ppm, Cd≤0.002ppm;

[0060] S5: Data integration and judgment. The fourth control unit summarizes the detection data of S2-S4. If all of them meet the qualification standards, they are judged as qualified; otherwise, unqualified items are marked and an alarm is triggered.

[0061] S6: Report Output and Traceability;

[0062] The cloud management unit automatically generates test reports containing the testing standard number, screenshots of the original data, and pass / fail determination, and stores them with associated UIDs, supporting mobile scanning or PC querying of the entire process data.

[0063] Please see Figure 1 This invention provides a quality inspection system for titanium alloy bars:

[0064] It includes a surface defect detection module, an internal integrity detection module, a medical-grade physicochemical performance testing module, and an IoT data traceability module;

[0065] The surface defect detection module consists of a high-resolution vision unit, a laser thickness detection unit, a microscopic verification unit, and a first control unit;

[0066] High-resolution visual unit: 20-megapixel line scan camera (scanning rate 5000 lines / second) + 50x optical lens + 550nm ring shadowless light source (illuminance 1500 lux);

[0067] Laser thickness measurement unit: Dual-channel laser thickness gauge (accuracy ±1μm, sampling frequency 1kHz);

[0068] Microscopic verification unit: Portable scanning electron microscope (SEM, 10nm resolution) + EDS energy dispersive spectrometer;

[0069] First control unit: equipped with a convolutional neural network (CNN) defect recognition model (training set contains 100,000+ artificial joint blank scratch samples).

[0070] The internal integrity detection module consists of a dual-frequency focused ultrasound unit, an ultrasound signal processing unit, a thermal imaging complementary unit, and a second control unit.

[0071] Dual-frequency focused ultrasound unit: Customized 10MHz high-frequency + 5MHz low-frequency composite probe (water immersion coupling, deionized water as the coupling agent);

[0072] Ultrasonic signal processing unit: integrates a 1GHz computing speed FPGA chip, equipped with an adaptive acoustic impedance compensation algorithm (compensation amount 15-20%).

[0073] Thermal imaging complementary unit: eddy current thermal imager (detection resolution 10μm, excitation power 0.5-1kW);

[0074] Second control unit: includes a reference value calibration module;

[0075] The medical-grade physicochemical performance testing module consists of a constant-temperature body fluid dynamics unit, a simulated body fluid corrosion unit, an ultra-trace element detection unit, and a third control unit;

[0076] Thermostatic fluid dynamics unit: 37℃±0.5℃ environmental simulation chamber + 100kN electronic universal testing machine (accuracy ±0.5%) + PTFE clamps;

[0077] Simulated body fluid corrosion unit: 500mL storage tank + 1mL / min peristaltic pump + electrochemical workstation (potential dynamic polarization method, scanning voltage -1.5~1.5V, rate 1mV / s);

[0078] Ultra-trace element detection unit: High-resolution inductively coupled plasma mass spectrometer (HR-ICP-MS, resolution 10000) + microwave digestion-acid removal device (digestion solution is analytical grade HNO3);

[0079] Third control unit: Automatically collects mechanical parameters (tensile / yield strength), corrosion rate (Vcorr), and elemental content data;

[0080] The IoT data traceability module consists of a UID coding unit, a data acquisition unit, a cloud management unit, and a fourth control unit;

[0081] The UID coding unit is a laser coding machine (coding depth ≤ 0.02mm, generating a unique QR code containing batch / specification / production time).

[0082] Data acquisition unit: RFID reader + multi-channel data acquisition card (acquiring surface / internal / physicochemical test data and equipment status);

[0083] Cloud Management Unit: Industrial Cloud Platform + Standardized Report Generation Module;

[0084] The fourth control unit enables barcode scanning for traceability, data export, and audit tracking.

[0085] Working principle:

[0086] S1: The servo robotic arm grabs the blank, the laser marking machine generates a UID on the end face, and the fourth control unit uploads it to the AWS IoT Greengrass cloud platform.

[0087] S2: The visual unit acquires surface images, and the CNN model identifies a 1.2mm long scratch 50mm from the end face. The laser thickness gauge detects H1=3μm and H2=48μm (|3-48|=45μm>90%×50μm=45μm, triggering microscopic verification). SEM observation shows no coating residue on the scratch cross section, and EDS detection shows that the Ti element accounts for 98%, which is determined to be a penetrating scratch.

[0088] S3: Dual-frequency ultrasonic probe scanning, the high-frequency channel detected a 0.15mm crack signal (amplitude exceeding the reference value by 3.2 times the standard deviation) near the surface of the billet (1.5mm depth), and the thermal imager simultaneously captured the 0.6℃ temperature difference point, which was determined to be a 0.1-0.3mm near-surface crack;

[0089] S4: Three billets from the same batch were sampled and subjected to constant-temperature fluid dynamics testing, yielding a tensile strength of 492 MPa and a yield strength of 351 MPa; simulated fluid corrosion testing yielded Vcorr = 0.004 mm / year; HR-ICP-MS analysis showed Pb = 0.0008 ppm, Hg = 0.0007 ppm, and Cd = 0.0015 ppm.

[0090] S5: Because S2 determined that there is a penetrating scratch, the fourth control unit marked the non-conforming item and issued an alarm;

[0091] S6: Generates test reports in the cloud, including SEM images, ultrasound C-scan images, elemental detection spectra, and linked UID storage. Complete test records can be viewed by scanning the code.

[0092] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention.

Claims

1. A method for quality inspection of titanium alloy bars, characterized in that: Includes the following steps: S1: The billet is fed and associated with the UID. The servo robotic arm grabs the billet, the UID coding unit generates a unique QR code, and the fourth control unit uploads it to the cloud management unit. S2: Surface defect detection, through a three-level process of visual screening, thickness correlation judgment and microscopic confirmation, to identify penetrating scratches; S3: Internal integrity inspection, which uses dual-frequency ultrasonic scanning and thermal imaging to determine the size and location of internal cracks; S4: Medical-grade physical and chemical performance sampling test, testing mechanical properties, simulated body fluid corrosion rate and ppb level harmful elements in a 37℃ body fluid environment; S5: Data integration and judgment. The fourth control unit summarizes the test data and determines whether the billet is qualified. S6: Report output and traceability. The cloud management unit generates standardized test reports and associates them with UIDs to achieve full-process traceability.

2. The method for quality inspection of titanium alloy bars according to claim 1, characterized in that: In step S2, the triggering condition for the thickness correlation determination is: the coating thickness H1 of the suspected area collected by the laser thickness detection unit and the coating thickness H2 of the defect-free area satisfy |H1-H2|>90%×coating design thickness. The microscopic confirmation is achieved by observing the cross-section of the scratch using SEM and detecting the percentage of coating elements using EDS energy dispersive spectroscopy. If the percentage of coating elements is less than 5%, it is determined to be a penetrating scratch.

3. The method for quality inspection of titanium alloy bars according to claim 2, characterized in that: In step S3, the condition for determining the internal crack is: the amplitude of the ultrasonic signal exceeds three times the standard deviation of the reference value, and the thermal imager captures a temperature anomaly point with a temperature difference greater than 0.5℃. The benchmark value is calibrated using a defect-free standard sample.

4. The method for quality inspection of titanium alloy bars according to claim 3, characterized in that: In step S4, the mechanical performance qualification standard is: tensile strength of TA2 material billet ≥ 485MPa, yield strength ≥ 345MPa; The acceptable corrosion rate standard is Vcorr≤0.005mm / year; The acceptable standards for harmful elements are Pb≤0.001ppm, Hg≤0.001ppm, and Cd≤0.002ppm.

5. The method for quality inspection of titanium alloy bars according to claim 4, characterized in that: The time required for single billet testing in steps S2-S3 is ≤30s, and the sampling ratio in step S4 is 3 billets per batch, with a physical and chemical testing cycle of ≤24h.

6. The method for quality inspection of titanium alloy bars according to claim 5, characterized in that: In step S6, the standardized test report includes the test standard number, screenshot of the original data and the qualification judgment, which complies with the "Requirements for Self-Inspection Report for Medical Device Registration" and supports mobile scanning or PC query and traceability.

7. A quality inspection system for titanium alloy bars, characterized in that: It includes a surface defect detection module, an internal integrity detection module, a medical-grade physicochemical performance testing module, and an IoT data traceability module; The surface defect detection module includes a high-resolution vision unit, a laser thickness detection unit, a microscopic verification unit, and a first control unit, wherein the first control unit is equipped with a convolutional neural network defect recognition model. The internal integrity detection module includes a dual-frequency focusing ultrasound unit, an ultrasound signal processing unit, a thermal imaging complementary unit, and a second control unit. The ultrasound signal processing unit integrates an FPGA chip and an adaptive acoustic impedance compensation algorithm. The medical-grade physicochemical performance testing module includes a constant temperature body fluid dynamics unit, a simulated body fluid corrosion unit, an ultra-trace element detection unit, and a third control unit. The constant temperature body fluid dynamics unit has a built-in 37℃±0.5℃ environmental simulation chamber and an ISO10993-5 standard simulated body fluid circulation device. The Internet of Things (IoT) data traceability module includes a UID coding unit, a data acquisition unit, a cloud management unit, and a fourth control unit. The data storage period of the cloud management unit is ≥5 years. The modules are connected via the Profinet industrial bus to enable real-time data interaction.

8. The titanium alloy bar quality inspection system according to claim 7, characterized in that: The dual-frequency focused ultrasound unit is a 10MHz high-frequency + 5MHz low-frequency composite probe, using water immersion coupling with deionized water as the coupling agent; the thermal imaging complementary unit is an eddy current thermal imager with a detection resolution ≤10μm.

9. The method and system for quality inspection of titanium alloy bars according to claim 8, characterized in that: The ultra-trace element detection unit is a high-resolution inductively coupled plasma mass spectrometer with a resolution ≥10000 and a detection limit of ≤0.001ppm for Pb and Hg; the simulated body fluid corrosion unit adopts the potentiodynamic polarization method with a scanning voltage range of -1.5~1.5V and a scanning rate of 1mV / s.

10. A quality inspection system for titanium alloy bars according to claim 9, characterized in that: The UID coding unit is a laser coding machine with a coding depth of ≤0.02mm. The generated unique QR code contains the batch number, specifications and production time information of the blank.

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