Low-extraction antistatic hand plate plastic material for medical apparatus and semiconductor and preparation technology thereof

Abstract

The application discloses a low-extraction antistatic hand plate plastic consumable for medical devices and semiconductors and a preparation technique, which is prepared from the following raw materials in percentage by weight: medical-grade PC resin 55-70%, medical-grade ABS-ESD resin 15-25%, composite antistatic agent 3-8%, compatibility agent 2-5%, medical-grade antioxidant 0.3-0.8%, lubricant 0.5-1.5%, and nano reinforcing agent 1-3%. The application adopts a high-molecular permanent antistatic agent and a modified inorganic antistatic agent to replace a traditional small-molecule antistatic agent, and combines with a medical-grade non-extraction aid agent, so that the migration and extraction of the antistatic agent, the lubricant and other components are effectively avoided. Through detection, the content of the extracted substances of the hand plate is less than or equal to 0.05 mg / cm2 after the hand plate is placed at 70 DEG C and 95% humidity for 72 hours, which meets the requirements of the medical device ISO10993 biocompatibility certification and REACH, RoHS and other environmental protection certification, and can be used for preclinical trial and high-precision test.

Description

Technical Field

[0001] This invention relates to the field of medical device prototypes, specifically to low-emission antistatic plastic prototypes for medical devices and semiconductors and their preparation technology. Background Technology

[0002] Medical device prototypes are core components used in the research and development of medical devices to verify design schemes, test product functions, and optimize structural details. They are widely used in the R&D stages of surgical instruments, in vitro diagnostic equipment, and wearable medical devices, and their performance directly affects R&D efficiency and the safety and reliability of the final product. With the rapid development of the medical device industry, the requirements for R&D prototypes are becoming increasingly stringent, especially in terms of low exudation and antistatic properties, where existing technologies struggle to address these challenges.

[0003] Currently, medical device prototypes are mostly made of common materials such as ABS, PC, and nylon. These materials have two major drawbacks: First, they have insufficient antistatic properties. During processing, storage, and use, medical device prototypes are prone to generating static electricity due to friction. Static electricity accumulation not only attracts dust and impurities from the air, affecting the cleanliness of the prototype, but may also interfere with the normal operation of internal electronic components of the medical device, and even pose safety hazards in flammable and explosive medical environments. Second, they produce a large amount of leaching. Additives in common materials (such as antistatic agents and plasticizers) are prone to leaching during long-term storage or contact with human body fluids and disinfection media. These leachings may react with the core components of the medical device, affecting product performance. At the same time, they do not meet the requirements of ISO 10993 biocompatibility certification for medical devices and environmental certifications such as REACH and RoHS, and cannot meet the needs of pre-clinical trials and high-precision testing. Summary of the Invention

[0004] The purpose of this invention is to provide low-emission antistatic plastic consumables for medical devices and semiconductors, and their preparation technology, in order to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a low-emission antistatic plastic consumable for medical devices and semiconductors, prepared from the following raw materials by weight percentage: 55%-70% medical-grade PC resin, 15%-25% medical-grade ABS-ESD resin, 3%-8% composite antistatic agent, 2%-5% compatibilizer, 0.3%-0.8% medical-grade antioxidant, 0.5%-1.5% lubricant, and 1%-3% nano-reinforcing agent; wherein the composite antistatic agent is a compound of polyether ester amide (PEEA) and nano-graphite powder modified with silane coupling agent KH-550, in a weight ratio of 2:1-3:1; the compatibilizer... The agent is maleic anhydride-grafted ABS (ABS-g-MAH); the medical-grade antioxidant is a compound of pentaerythritol tetrakis(β-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) and tris(2,4-di-tert-butylphenyl)phosphite, with a weight ratio of 1:1-1:2; the lubricant is medical-grade calcium stearate; the nano-reinforcing agent is nano-silica modified with a silane coupling agent, with a particle size of 50-100 nm; the melt flow rate of the medical-grade PC resin is 10-20 g / 10 min (test temperature 260℃, test weight 2.16 kg), and the surface resistivity of the medical-grade ABS-ESD resin is 10 Ω·cm. 6 -10 9 Ω, and all meet the ISO10993 biocompatibility certification requirements.

[0006] As a preferred embodiment of the present invention, the raw materials are in the following weight percentages: 62% medical-grade PC resin, 20% medical-grade ABS-ESD resin, 6% composite antistatic agent, 3% compatibilizer, 0.5% medical-grade antioxidant, 1% lubricant, and 2% nano-reinforcing agent; in the composite antistatic agent, the weight ratio of polyether ester amide to modified nano-graphite powder is 2.5:1.

[0007] As a preferred embodiment of the present invention, the modified nano-graphite powder is prepared by: adding nano-graphite powder to deionized water and ultrasonically dispersing it for 30-60 minutes to obtain a dispersion; adding silane coupling agent KH-550 to the dispersion, wherein the amount of silane coupling agent added is 3%-5% of the weight of the nano-graphite powder; stirring at 60-80℃ for 2-3 hours; filtering, drying, and pulverizing to obtain the final product.

[0008] The preparation technology of low-emission antistatic plastic consumables for medical devices and semiconductors includes the following steps:

[0009] S1. Raw material pretreatment: Medical grade PC resin and medical grade ABS-ESD resin are vacuum dried at 80-100℃ for 4-6 hours; composite antistatic agent, compatibilizer, medical grade antioxidant, lubricant and nano reinforcing agent are pulverized to a particle size of no more than 100 mesh and set aside.

[0010] S2. Mixing and granulation: Add all the pretreated raw materials to a high-speed mixer and mix for 15-20 minutes at a speed of 800-1000 r / min and a temperature of 60-80℃ to obtain a premix; feed the premix into a twin-screw extruder and melt-extrude and granulate at 220-260℃ with the main extruder speed of 250-350 r / min to obtain low precipitation antistatic composite particles;

[0011] S3. Prototype Forming: Vacuum dry the composite particles at 80-90℃ for 2-3 hours, then form them using CNC machining or 3D printing. For CNC machining, the cutting speed is 800-1200r / min, the feed rate is 200-300mm / min, and the cutting depth is 0.1-0.3mm. For 3D printing, the accuracy is controlled within ±0.05mm. After printing, a curing process is performed.

[0012] S4. Post-processing: Grind and polish the molded prototype until the surface roughness Ra≤0.2μm. Let it stand for 12-24 hours under the conditions of temperature 23±2℃ and humidity 50±5% for aging treatment. Finally, wipe it clean with medical grade alcohol to obtain the finished product.

[0013] As a preferred embodiment of the present invention, in step S3, the 3D printing adopts SLA or SLS process, the photosensitive resin used for printing meets ISO10993 biocompatibility certification, and the curing conditions are: irradiation under ultraviolet light with a wavelength of 365nm and an intensity of 80-100mW / cm² for 30-60 minutes.

[0014] As a preferred embodiment of the present invention, in step S4, sanding is performed using sandpaper with gradually finer grits from 200 to 1000 grit, and polishing is performed using medical-grade polishing paste.

[0015] Compared with the prior art, the beneficial effects of the present invention are:

[0016] 1. Excellent low-exudation performance: This invention uses a combination of a high-molecular permanent antistatic agent and a modified inorganic antistatic agent to replace the traditional small-molecule antistatic agent. Combined with medical-grade non-exudation additives, it effectively avoids the migration and exudation of antistatic agents, lubricants and other components. According to the test, after the hand plate is placed at 70℃ and 95% humidity for 72 hours, the exudate content is ≤0.05mg / cm², which meets the requirements of ISO10993 biocompatibility certification for medical devices and environmental certifications such as REACH and RoHS. It can be used for pre-clinical trials and high-precision testing.

[0017] 2. Long-lasting and stable antistatic performance: The polyether ester amide (PEEA) in the composite antistatic agent can form a stable molecular bond with the resin matrix, and the modified nano-graphite powder can construct a continuous conductive network. The synergistic effect of the two keeps the surface resistance of the hand plate stable at 10 ohms. 6 -10 9Ω, static dissipation time ≤2s, long-lasting antistatic effect, effectively avoids the problem of static electricity attracting dust and interfering with the operation of electronic components, and is suitable for the use of various precision medical device prototypes.

[0018] 3. High mechanical strength and dimensional accuracy: By adding nano-reinforcing agents and compatibilizers, the compatibility and interfacial bonding between PC and ABS-ESD resin are improved. The tensile strength of the prototype is ≥65MPa, the impact strength is ≥25kJ / m², and the dimensional accuracy is controlled within ±0.05mm. It can accurately reproduce the structural details of medical devices and meet the needs of assembly testing and functional verification. At the same time, high-precision processing technology and aging treatment are adopted to eliminate internal stress during processing, improve the dimensional stability of the prototype, and avoid deformation during use.

[0019] 4. Good biocompatibility: All raw materials are medical-grade and meet ISO10993 biocompatibility certification. They are non-toxic and non-irritating, and can be directly used in medical device prototypes that come into contact with the human body (such as prosthetic sleeves, orthodontic models, etc.). They also have good disinfection resistance and can withstand repeated wiping with common medical disinfectants such as alcohol and ethylene oxide. Their performance is stable.

[0020] 5. Simple and controllable preparation process: The preparation method of this invention has a clear process flow. The steps such as mixing and granulation, molding and post-processing are easy to operate in industrialization. The parameters are controllable. CNC machining or 3D printing technology can be flexibly adopted according to the size and structural requirements of different medical device prototypes. The production efficiency is high, suitable for large-scale production, and reduces the R&D cost of medical devices. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the manufacturing process of low-emission antistatic plastic consumables for medical devices and semiconductors according to the present invention. Detailed Implementation

[0022] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0023] In the description of this invention, it should be noted that the terms "upper," "lower," "inner," "outer," "front end," "rear end," "both ends," "one end," and "the other end," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and for 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 limitations on this invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0024] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installed," "equipped with," "connected," etc., should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0025] Please see Figure 1 The present invention provides an embodiment of: low-emission antistatic plastic consumables for medical devices and semiconductors and their preparation technology.

[0026] Example 1

[0027] A low-emission antistatic plastic consumable for medical devices and semiconductors is prepared from the following raw materials by weight percentage:

[0028] The composition includes 55% medical-grade PC resin, 25% medical-grade ABS-ESD resin, 8% composite antistatic agent, 5% compatibilizer (ABS-g-MAH), 0.8% medical-grade antioxidant, 1.5% lubricant (calcium stearate), and 4.7% nano-reinforcing agent (modified nano-silica).

[0029] The composite antistatic agent is a mixture of polyether ester amide (PEEA) and modified nano-graphite powder in a weight ratio of 2:1. The modified nano-graphite powder is prepared by adding nano-graphite powder to deionized water, ultrasonically dispersing for 30 min, adding 3% of the weight of nano-graphite powder with silane coupling agent KH-550, stirring at 60℃ for 2 h, filtering, drying, and pulverizing. The medical-grade antioxidant is a mixture of antioxidant 1010 and antioxidant 168 in a weight ratio of 1:1. The nano-reinforcing agent is nano-silica modified with silane coupling agent with a particle size of 50 nm.

[0030] The method for preparing this prototype includes the following steps:

[0031] S1. Raw material pretreatment: Place medical-grade PC resin and medical-grade ABS-ESD resin into a vacuum drying oven and dry at 80℃ for 6 hours; pulverize the composite antistatic agent, compatibilizer, medical-grade antioxidant, lubricant, and nano-reinforcing agent into particles with a particle size of no more than 100 mesh for later use.

[0032] S2. Mixing and granulation: Add all pretreated raw materials to a high-speed mixer and mix for 20 minutes at 800 r / min and 60℃ to obtain a premix. Feed the premix into a twin-screw extruder and control the extrusion temperature as follows: Zone 1 80℃, Zone 2 190℃, Zone 3 220℃, Zone 4 240℃, Zone 5 240℃, and die head 230℃. The main extruder speed is 250 r / min. After extrusion, cool and granulate to obtain composite granules.

[0033] S3. Hand-made prototype forming: The composite particles are dried at 80℃ for 3 hours and formed by CNC machining process with a cutting speed of 800r / min, a feed rate of 200mm / min, and a cutting depth of 0.1mm.

[0034] S4. Post-processing: Gradually sand the prototype with 200-1000 grit sandpaper, and polish it with medical-grade polishing paste to make the surface roughness Ra≤0.2μm; let it stand in a constant temperature and humidity chamber at 23℃ and 50% humidity for 24 hours for aging treatment; wipe it clean with medical-grade alcohol to obtain the final product.

[0035] Example 2

[0036] A low-emission antistatic plastic consumable for medical devices and semiconductors is prepared from the following raw materials by weight percentage:

[0037] The composition includes: 62% medical-grade PC resin, 20% medical-grade ABS-ESD resin, 6% composite antistatic agent, 3% compatibilizer (ABS-g-MAH), 0.5% medical-grade antioxidant, 1% lubricant (calcium stearate), and 7.5% nano-reinforcing agent (modified nano-silica).

[0038] The composite antistatic agent is a compound of polyether ester amide (PEEA) and modified nano-graphite powder in a weight ratio of 2.5:1. The modified nano-graphite powder is prepared by adding nano-graphite powder to deionized water, ultrasonically dispersing for 45 min, adding 4% of the weight of nano-graphite powder with silane coupling agent KH-550, stirring at 70℃ for 2.5 h, filtering, drying, and pulverizing. The medical-grade antioxidant is a compound of antioxidant 1010 and antioxidant 168 in a weight ratio of 1:1.5. The nano-reinforcing agent is nano-silica modified with silane coupling agent with a particle size of 80 nm.

[0039] The method for preparing this prototype includes the following steps:

[0040] S1. Raw material pretreatment: Place medical-grade PC resin and medical-grade ABS-ESD resin into a vacuum drying oven and dry at 90℃ for 5 hours; pulverize the composite antistatic agent, compatibilizer, medical-grade antioxidant, lubricant, and nano-reinforcing agent into particles with a size not exceeding 100 mesh for later use.

[0041] S2. Mixing and granulation: Add all pretreated raw materials to a high-speed mixer and mix for 18 minutes at a speed of 900 r / min and a temperature of 70℃ to obtain a premix. Feed the premix into a twin-screw extruder and control the extrusion temperature as follows: Zone 1 90℃, Zone 2 200℃, Zone 3 230℃, Zone 4 250℃, Zone 5 250℃, and die head 240℃. The main extruder speed is 300 r / min. After extrusion, cool and granulate to obtain composite granules.

[0042] S3, Prototype Forming: The composite particles are dried at 85℃ for 2.5h and formed using SLS3D printing technology. The printing accuracy is controlled within ±0.05mm. After printing, the particles are cured under ultraviolet light with a wavelength of 365nm and an intensity of 90mW / cm² for 45min.

[0043] S4. Post-processing: Gradually polish the prototype with 200-1000 grit sandpaper, and polish it with medical-grade polishing paste to make the surface roughness Ra≤0.2μm; let it stand in a constant temperature and humidity chamber at 23℃ and 50% humidity for 18 hours for aging treatment; wipe it clean with medical-grade alcohol to obtain the final product.

[0044] Example 3

[0045] A low-emission antistatic plastic consumable for medical devices and semiconductors is prepared from the following raw materials by weight percentage:

[0046] The composition includes 70% medical-grade PC resin, 15% medical-grade ABS-ESD resin, 3% composite antistatic agent, 2% compatibilizer (ABS-g-MAH), 0.3% medical-grade antioxidant, 0.5% lubricant (calcium stearate), and 9.2% nano-reinforcing agent (modified nano-silica).

[0047] The composite antistatic agent is a mixture of polyether ester amide (PEEA) and modified nano-graphite powder in a weight ratio of 3:1. The modified nano-graphite powder is prepared by adding nano-graphite powder to deionized water, ultrasonically dispersing for 60 min, adding 5% of the weight of nano-graphite powder with silane coupling agent KH-550, stirring at 80℃ for 3 h, filtering, drying, and pulverizing. The medical-grade antioxidant is a mixture of antioxidant 1010 and antioxidant 168 in a weight ratio of 1:2. The nano-reinforcing agent is nano-silica modified with silane coupling agent with a particle size of 100 nm.

[0048] The method for preparing this prototype includes the following steps:

[0049] S1. Raw material pretreatment: Place medical-grade PC resin and medical-grade ABS-ESD resin into a vacuum drying oven and dry at 100℃ for 4 hours; pulverize the composite antistatic agent, compatibilizer, medical-grade antioxidant, lubricant, and nano-reinforcing agent into particles with a size not exceeding 100 mesh for later use.

[0050] S2. Mixing and granulation: Add all pretreated raw materials to a high-speed mixer and mix for 15 minutes at a speed of 1000 r / min and a temperature of 80℃ to obtain a premix. Feed the premix into a twin-screw extruder and control the extrusion temperature as follows: Zone 1 100℃, Zone 2 210℃, Zone 3 240℃, Zone 4 260℃, Zone 5 260℃, and die head 250℃. The main extruder speed is 350 r / min. After extrusion, cool and granulate to obtain composite granules.

[0051] S3, Prototype Forming: The composite particles are dried at 90℃ for 2 hours and formed using SLA 3D printing technology. The printing accuracy is controlled within ±0.05mm. After printing, the particles are cured under ultraviolet light with a wavelength of 365nm and an intensity of 100mW / cm² for 30 minutes.

[0052] S4. Post-processing: Gradually polish the prototype with 200-1000 grit sandpaper, and polish with medical-grade polishing compound to make the surface roughness Ra≤0.2μm; let it stand in a constant temperature and humidity chamber at 23℃ and 50% humidity for 12 hours for aging treatment; wipe it clean with medical-grade alcohol to obtain the final product.

[0053] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A low-emission antistatic plastic consumable for medical devices and semiconductors, characterized in that: It is prepared from the following raw materials in weight percentages: 55%-70% medical-grade PC resin, 15%-25% medical-grade ABS-ESD resin, 3%-8% composite antistatic agent, 2%-5% compatibilizer, 0.3%-0.8% medical-grade antioxidant, 0.5%-1.5% lubricant, and 1%-3% nano-reinforcing agent; the composite antistatic agent is a compound of polyether ester amide (PEEA) and nano-graphite powder modified with silane coupling agent KH-550, with a weight ratio of 2:1-3:1; the compatibilizer is maleic anhydride grafted ABS (ABS-g-MAH). The medical-grade antioxidant is a compound of pentaerythritol tetrakis(β-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) and tris(2,4-di-tert-butylphenyl)phosphite, with a weight ratio of 1:1 to 1:2; the lubricant is medical-grade calcium stearate; the nano-reinforcing agent is nano-silica modified with a silane coupling agent, with a particle size of 50-100 nm; the melt flow rate of the medical-grade PC resin is 10-20 g / 10 min (test temperature 260℃, test weight 2.16 kg); and the surface resistivity of the medical-grade ABS-ESD resin is 10 Ω·cm. 6 -10 9 Ω, and all meet the ISO10993 biocompatibility certification requirements.

2. The low-emission antistatic plastic consumable for medical devices and semiconductors according to claim 1, characterized in that, The raw materials have the following weight percentages: 62% medical-grade PC resin, 20% medical-grade ABS-ESD resin, 6% composite antistatic agent, 3% compatibilizer, 0.5% medical-grade antioxidant, 1% lubricant, and 2% nano-reinforcing agent; in the composite antistatic agent, the weight ratio of polyether ester amide to modified nano-graphite powder is 2.5:

1.

3. The low-emission antistatic plastic consumable for medical devices and semiconductors according to claim 1, characterized in that, The modified nano-graphite powder is prepared as follows: nano-graphite powder is added to deionized water and ultrasonically dispersed for 30-60 min to obtain a dispersion; silane coupling agent KH-550 is added to the dispersion, the amount of silane coupling agent added is 3%-5% of the weight of nano-graphite powder, and the mixture is stirred at 60-80℃ for 2-3 h, filtered, dried, and pulverized to obtain the final product.

4. A method for preparing a low-emission antistatic handplate for medical devices as described in any one of claims 1-3, characterized in that, Includes the following steps: S1. Raw material pretreatment: Medical grade PC resin and medical grade ABS-ESD resin are vacuum dried at 80-100℃ for 4-6 hours; composite antistatic agent, compatibilizer, medical grade antioxidant, lubricant and nano reinforcing agent are pulverized to a particle size of no more than 100 mesh and set aside. S2. Mixing and granulation: Add all the pretreated raw materials to a high-speed mixer and mix for 15-20 minutes at a speed of 800-1000 r / min and a temperature of 60-80℃ to obtain a premix; feed the premix into a twin-screw extruder and melt-extrude and granulate at 220-260℃ with the main extruder speed of 250-350 r / min to obtain low precipitation antistatic composite particles; S3. Prototype Forming: Vacuum dry the composite particles at 80-90℃ for 2-3 hours, then form them using CNC machining or 3D printing. For CNC machining, the cutting speed is 800-1200r / min, the feed rate is 200-300mm / min, and the cutting depth is 0.1-0.3mm. For 3D printing, the accuracy is controlled within ±0.05mm. After printing, a curing process is performed. S4. Post-processing: Grind and polish the molded prototype until the surface roughness Ra≤0.2μm. Let it stand for 12-24 hours under the conditions of temperature 23±2℃ and humidity 50±5% for aging treatment. Finally, wipe it clean with medical grade alcohol to obtain the finished product.

5. The preparation method according to claim 4, characterized in that, In step S3, the 3D printing adopts SLA or SLS process, the photosensitive resin used for printing meets ISO10993 biocompatibility certification, and the curing conditions are: irradiation under ultraviolet light with a wavelength of 365nm and an intensity of 80-100mW / cm² for 30-60 minutes.

6. The preparation method according to claim 4, characterized in that, In step S4, sanding is done with sandpaper that gradually fines from 200 grit to 1000 grit, and polishing is done with medical-grade polishing paste.

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