VDI 3400 Texture Material:

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1 Medical injection molding for diagnostic equipment. It is used for clinical diagnosis in hospital. It is made for our Singapore customer. low volume production for second type medial device with high requirements. Competitive price both for mold and plastic enclosure. Project details as below : Type: medical injection Core surface finish: polishing molding Production Medical grade A Cavity surface finish: VDI 3400 Texture Material: BS No of Cavities: 2 cavities Injection System Cold runner Core Material: LKM S136H Type of gating: Sub gate Cavity Material: LKM S136H Ejection system: Ejection pin Slider material: N/A Lead time for T1: 5 weeks Mold base steel: SS420H Shot life: Total Mold Price : EUR 8500 Manufactures: Asia Billion Product Characters: 1) Medical grade ABS plastic material 2) Great surface and material for antipollution 3) Low volume production 4) VDI 3400 MATT finishing Asia Billion is one stop supplier for your medical device plastic enclosures and medical plastic injection molding needed. All our medical device plastic injection mold or medical plastic enclosure are according to USA FDA SPI Mold Class 101 to 105. we can help you realize your ideals from concept to mass production with engineering production design and manufacturing feasibility improvement capacity. We have more than 20 years quality medical plastic enclosure injection molding and mold fabrication experience. If you have any medical enclosure of plastic injection molding or similar with this, please contact us freely. Asia Billion medical injection mold making process:

2 Our Medical Plastic Injection molding Tool shop Overview:

3 Asia Billion Quality Control Our Logistic Solution

4 Classification and misunderstanding of medical devices 1. What is a medical device? Medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials and other similar or related articles used directly or indirectly in the human body, including the required computer software; their utility is mainly obtained through physical means, not Obtained by pharmacology, immunology or metabolism, or although they are involved, but only play a supporting role; the purpose is: (1) Diagnosis, prevention, monitoring, treatment or relief of the disease; (2) Diagnosis, monitoring, treatment, mitigation or functional compensation of the injury; (3) Testing, substitution, adjustment or support of physiological structures or physiological processes; (4) Support or maintenance of life; (5) Pregnancy control;

5 (6) Provide information for medical or diagnostic purposes by examining samples from the human body. 2. How to classify medical device products? The state implements classified management of medical devices according to the degree of risk. The first category is a medical device that has a low level of risk and is routinely managed to ensure its safety and effectiveness. Such as: surgical instruments (knives, scissors, pliers, sputum, hooks), scraping plates, medical X-ray film, surgical gowns, surgical caps, inspection gloves, gauze bandages, drainage bags and so on. Surgical instruments belong to the first category of medical devices The second category is medical devices that have moderate risks and require strict control to ensure their safety and effectiveness. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, EEG machines, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic disinfection equipment, non-absorbable sutures, condoms, etc. The familiar mercury sphygmomanometer belongs to the second category of medical devices. The third category is medical devices that have high risks and require special measures to strictly control management to ensure their safety and effectiveness. Such as: implantable cardiac pacemaker, contact lens, intraocular lens, ultrasound tumor focusing knife, hemodialysis device, implant device, vascular stent, comprehensive anesthesia machine, dental implant material, medical absorbable suture, blood vessel Inner catheter, etc.

6 Several implantable medical devices: It can be seen that the state has a strict classification of medical devices, and the three types of medical devices are the highest level of medical devices, and are also medical devices that must be strictly controlled. They are implanted into the human body to support and sustain life, and are potentially dangerous to the human body. Medical device must be strictly controlled for its safety and effectiveness. 3. What are the medical device standards? Medical device standards are divided into national standards and industry standards. (1) National standards or industry standards refer to standards that require uniform technical requirements across the country. (2) National standards should be established for technical requirements that need to be unified across the country. National standards are formulated by the competent department of standardization administration under the State Council. Industry standards can be established for technical requirements that do not have national standards but need to be harmonized within a certain industry across the country. The industry standards shall be formulated by the relevant administrative department of the State Council and reported to the standardization administrative department of the State Council for the record. The national standards and industry standards are divided into mandatory standards and recommended standards. The State Food and Drug Administration (CFDA) promulgated the "Administrative Measures for Medical Device Standards" 4. Is it necessary to pass the inspection before the medical device is approved for marketing? When registering the second and third types of medical devices, they need to go to the inspection and testing institutions approved by the State Food and Drug Administration for registration and testing.

7 5. What is the scope of application of medical device products? The scope of application of medical device products is generally approved by the food and drug supervision and administration department on the basis of clinical trials, and may not be exaggerated or changed at will. Therefore, consumers should carefully check the scope of application, contraindications, precautions, etc. before purchasing to analyze whether the product is suitable. 6. What are the common misunderstandings about medical devices? (1) Misunderstanding 1: Medical devices are high-risk. Medical devices can only be used in hospitals, and medical personnel are required to use them. In fact, according to the degree of risk, the state divides medical devices into three categories. The risk of the first type of medical devices is relatively low. The public can guarantee the basic safety through certain learning and consulting instructions. Many products can be used at home. Some of the second types of medical devices are also available for household use. The third type medical devices are used at a high risk, and a small number of them can be used at home, but they should be used strictly in accordance with the scope of application of the product registration certificate and the specifications. (2) Misunderstanding 2: Non-medical devices are regarded as medical devices, such as fitness, slimming, increase and health care products, and are regarded as medical devices. Non-medical devices do not have a medical device registration number, which can be clearly distinguished from this point. (3) Misunderstanding 3: As long as it is a medical device, it is more beneficial to health than non-medical devices. The two are not comparable. Medical equipment is a special product. Its production and sales need to undergo strict examination and approval management, with its certain use functions and adapt to the crowd; it is not suitable to use the medical equipment outside the scope of the crowd. Non-medical devices are more widely adapted, and their main function is not for medical purposes, but for the respective efficacy of the products.

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