Quality frontier | Construction of professional testing laboratory to keep the first pass of product quality
No development without quality, and quality inspection is an indispensable part of quality management, which is the key to ensuring product quality.
No development without quality, and quality inspection is an indispensable part of quality management, which is the key to ensuring product quality.invested in the purchase of fully functional and industry-leading testing equipment, and established a standard laboratory with efficient operations in strict accordance with ISO/IEC17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories.
The laboratory is equipped withendoscope optical testing, safety testing, electromagnetic compatibility testing, environmental and reliability testing, packaging and simulated transportation testing,etc., providing professional and leading testing capabilities for the innovative development and large-scale application of high-quality products.
Optical laboratory
As a system integration product with optical imaging as its main function,其the optical design and testing of endoscopesare two core technical difficulties.The optical performance and imaging,quality of endoscope are涉及directly or indirectly relatedto the safety, of diagnosis and treatment of patients,so the importance of detection is self-evident. in the listing certification of endoscope products,the testing results of optical indicators account for a higher proportion.
The optical design of endoscope needs to consider the technical requirements of image quality, optical path design, aberration correction, tolerance adjustment and so on. 华芯According to YY/T 1587-2018 "Medical Endoscope Electronic Endoscope Standard", YY/T 1603-2018 "Medical Endoscope Endoscope Function Supply Device Camera System Standardand tesrequirements,Vathin specially customized an endoscope comprehensive index measurement system,and it accuratelyit accurately,signal-to-noise ratio, brightness response characteristics, spatial frequency response, distortion, illumination mirror light efficiency, color reproduction degree and other very important core product indicators through it and the cold light source test system,,so that it ensure the effectiveness, durability and stability of the product according to the measurement results.。
Safety Laboratory
Safety regulations are the requirements for product safety in product certification,。including safety requirements for product components and finished products. For medical electrical products, electrical safety and mechanical reliability are the most important considerations for Vathin.
he electrical testing and safety lab enables Vathin to achieve accurate electrical measurements and data control. Vathin trictly follows GB 9706.1-2020/IEC 60601 "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Basic Performance" to ensure the safety of the products,,以and uses a series of testing equipments such as safety compliance testersleakage current tester, inverter power supply, etc., to test the product's protective ground impedance, leakage current, dielectric strength, residual power supply, power input, waterproofing, noise, over-temperature and other parameters to ,make a judgment on whether the tested sample meets the "basic safety" or not.。
EMCElectromagnetic Compatibility Laboratory
Electromagnetic compatibility is the ability of a device or system to operate within its electromagnetic environment in accordance with requirements, without generating intolerable electromagnetic interference to any devices in its environment.。
Through the most typicalnterference suchas common static electricity,pulse and conduction,以Vathin uses electrostatic discharge simulator,electric fast transient pulse group simulator and conduction immunity tester toonduct anti-interference simulation test of products,to ensure that the electrostatic immunity ESD, electric fast transient pulse group test EFT and conduction immunity CS of products in the normal operation process are within the specified standard limits.。
Environmental Laboratory
Accelerated stability tests, which simulate real-time aging by storing samples in a higher temperature condition for a shorter period of time, can be used to accelerate product launch requirements.
The testing center has established a complete product inspection system through equipment such as constant temperature and humidity chambers and salt spray test chambers, which enables accelerated aging tests, salt spray tests, high and low temperature cycle tests, and other tests, to quickly detect the service life and performance stability of products in daily environments during the R&D and production stages.。
At the same time, the testing center will also store the samples under the specified actual storage conditions, conduct real-time stability tests, and report and feedback the quality inspection information to the company's research and development and production departments in a timely manner, providing the basis for the company to study and solve product quality problems, thus continuously improving and enhancing product quality and ensuring product quality and stability.
Packaging and Transportation Simulation Laboratory
Whether conducting accelerated stability testing or real-time stability testing, it is necessary to conduct corresponding testing projects for the product itself and the packaging system to evaluate the performance of the product as it ages over time。
Vathin uses drop test machines, stacking test machines, vibration tables, and other simulation transportation equipment to simulate the conditions that products may experience during packaging and transportation. It conducts a series of simulation tests, including drop tests, stacking tests, unrestrained vibration (fixed frequency vibration), carrier stacking (random vibration), sealing strength, vacuum leakage, dye penetration, and more.
After the simulation experiment, the performance of the product needs to be tested. When inspecting the all-inclusive product from transportation to delivery to the user, the product's mechanical performance still meets the expected performance requirements at the factory, ensuring the reliability of the packaging.
General Laboratory
The ultimate purpose of testing is to ensure that the final product delivered to the user, its function meets the needs of the user, that is, to ensure that the product performance is stable and can adapt to the user environment, meet the requirements of performance and efficiency, and can achieve the promised functions。
The test center verifies the operational reliability of the products by testing a number of data such as appearance, size, suction volume, water delivery, bending angle, and laser compatibility through holmium laser, medical suction pump and other equipment.
The test center verifies the operational reliability of the products by testing a number of data such as appearance, size, suction volume, water delivery, bending angle, and laser compatibility through holmium laser, medical suction pump and other equipment.is also the first pass to ensure the quality of products. The testing center effectively guarantees the R & D and production of Vathin with full spirit, and ensures the completion of various tasks with high quality .。
The testing center effectively guarantees the R & D and production of Vathin with full spirit, and ensures the completion of various tasks with high quality .:manager of the testing center, said: Vathin is going to build a CNAS-compliant and specialized endoscope professional testing laboratory. 。Vathin will continue to promote the construction of quality inspection, strive to improve the technical level, ensure the accuracy and reliability of the inspection results, and make unremitting efforts to create high-quality products of Vathin Medical.