In the medical device industry, the reliability and performance of products are of utmost importance as they directly impact patient safety and healthcare outcomes. Medical devices are often exposed to a wide range of temperature conditions during storage, transportation, and use. Our Custom Two - Zone Hot - Cold Shock Test Chamber is a specialized and essential tool designed to meet the unique testing requirements of medical device products. This advanced chamber enables precise simulation of extreme hot and cold conditions, allowing manufacturers and regulatory bodies to evaluate the durability, functionality, and safety of medical devices under realistic thermal scenarios.
The core of this test chamber is its two - zone design, offering highly accurate and independent temperature control. Zone 1 is dedicated to simulating cold environments, with a temperature range typically from - 20°C to 0°C, maintaining an accuracy of ± 0.3°C. This zone can replicate the conditions of cold storage, such as in a pharmacy refrigerator or during transportation in cold climates. Zone 2 is designed to mimic hot conditions, covering a range from 37°C to 70°C, also with an accuracy of ± 0.3°C. The 37°C setting is particularly relevant as it represents the human body temperature, while the upper range can simulate extreme heat during sterilization processes or storage in warm environments. The precise temperature control in both zones ensures that medical device products can be tested under a wide variety of realistic thermal scenarios.
One of the most critical features of this chamber is its ability to achieve rapid thermal transitions between the two zones. In just 2 - 3 seconds, it can switch from the cold conditions of Zone 1 to the hot conditions of Zone 2, and vice versa. This closely mimics the sudden temperature changes that medical devices may encounter in real - world situations. For example, a medical device may be stored in a cold environment and then quickly used in a warm operating room, or it may experience temperature fluctuations during transportation between different climate zones. The short transition time is essential for accurately detecting potential failures in the device due to thermal stress, such as cracks in the housing, malfunction of electronic components, or changes in the properties of materials used in the device.
We understand that different medical device products have unique thermal requirements based on their design, function, and intended use. Therefore, our chamber offers fully customizable test profiles. Manufacturers and testers can program specific temperature cycles, dwell times, and transition rates for each zone according to the specific characteristics of the medical device being tested. For instance, a temperature - sensitive implantable device may require a specific test profile that closely mimics the temperature changes it will experience inside the human body. A diagnostic device may need a test profile that accounts for the temperature variations during storage and transportation. This flexibility in test profile customization ensures that each medical device is tested under the most relevant and realistic thermal conditions, resulting in more reliable and actionable test results.
The chamber is designed with a spacious interior to accommodate a wide variety of medical device products, from small disposable syringes and sensors to large imaging equipment and surgical instruments. The standard chamber capacities range from 49 cubic meters to 1000 cubic meters, and can be customized to meet the specific requirements of larger or more complex medical devices. This allows for the testing of multiple units simultaneously or the evaluation of complete medical device systems, improving testing efficiency and reducing costs. Whether it's testing a single insulin pen or an entire magnetic resonance imaging (MRI) machine component, the large chamber capacity provides the necessary space for comprehensive testing.
Built with high - quality materials and advanced engineering techniques, the hot - cold shock test chamber is designed to withstand the rigors of continuous use in a medical testing environment. The exterior is constructed from a corrosion - resistant and easy - to - clean material, such as stainless steel, which can endure exposure to various cleaning agents and disinfectants used in medical facilities. The internal components, including heating, cooling, and control systems, are carefully selected and engineered for maximum durability and reliability. Additionally, the chamber is designed to meet strict hygiene standards, with smooth surfaces and no areas where contaminants can accumulate. This robust and hygienic construction ensures consistent test results over time and helps maintain a clean and safe testing environment.
The chamber is equipped with a user - friendly interface that simplifies the testing process while maintaining the highest level of security. The intuitive touch - screen control panel allows authorized operators to easily set up test parameters for each zone, start and stop tests, and monitor real - time temperature data. The interface also provides access to historical test data, enabling users to analyze trends and make informed decisions about product design and quality improvement. To ensure the security of the testing process, the interface is protected by multiple levels of authentication and encryption. Only authorized personnel can access the system, and all data transmitted and stored is encrypted to prevent unauthorized access or tampering, especially important when dealing with sensitive medical device testing data.
| Model | TSC-49-3 | TSC-80-3 | TSC-150-3 | TSC-216-3 | TSC-512-3 | TSC-1000-3 |
| Inside dimension(W x D x H) mm | 40 x 35 x 35 | 50 x 40 x 40 | 65x 50 x 50 | 60 x 60 x 60 | 80 x 80 x 80 | 100 x 100 x 100 |
| Outside dimension(W x D x H) mm | 128x 190 x 167 | 138 x 196 x 172 | 149 x 192 x 200 | 158 x 220 x 195 | 180 x 240 x 210 | 220 x 240x 220 |
| Internal material | #304 Stainless Steel |
| External material | Powder coated #304 Stainless Steel |
| High temperature range | 60 ℃ ~ 200 ℃ |
| Low temperature range | 0 ℃ ~ -70 ℃ |
| Test temperature range | 60 ℃ ~ 180 ℃ / 0 ℃ ~ -70 ℃ |
| Temperature recovery time | 1-5min |
| Temperature stability ℃ | ±2 |
| Cylinder switching time | 10s |
| High temperature ℃ | 150 | 150 | 150 | 150 | 150 | 150 |
| Heating time (min) | 20 | 30 | 30 | 30 | 30 | 30 |
| Low temperature | -40, -50, -65 | -40, -50, -65 | -40, -50, -65 | -40, -50, -65 | -40, -50, -65 | -40, -50, -65 |
| Cooling time (min) | 40, 50, 60 | 40, 50, 60 | 40, 50, 60 | 40, 50, 60 | 40, 50, 60 | 40, 50, 60 |
| Air circulation system | Mechanical convection system |
| Cooling system | Imported compressor, fin evaporator, gas condenser |
| Heating system | Fin heating system |
| Humidification system | Steam Generator |
| Humidification water supply | Reservoir, Sensor-controller solenoid valve, recovery-recycle system |
| Controller | Touch panel |
| Electrical power requirements | 3 phase 380V 50/60 Hz |
| Safety device | Circuit system load protection, compressor load protection, control system load protection, humidifier load protection, overtemperature load protection, fault warning light |
Subjecting medical device products to realistic hot - cold shock tests in our two - zone chamber allows manufacturers to identify and address potential weaknesses in design, material selection, and manufacturing processes. By exposing the devices to extreme temperature variations, manufacturers can detect issues such as material degradation, component failures, and changes in electrical or mechanical properties. This enables them to make necessary design modifications and manufacturing improvements, resulting in higher - quality medical devices that are more resistant to thermal stress and have a longer lifespan. Devices that pass these rigorous tests are less likely to experience failures during use, ensuring patient safety and the effectiveness of medical treatments.
Early detection of device failures through hot - cold shock testing can save medical device manufacturers significant costs. By identifying and resolving issues before mass production, companies can avoid expensive rework, production delays, and the potential for product recalls. The ability to test multiple units simultaneously or conduct full - scale testing in the large - capacity chamber also reduces testing time and costs, improving the overall efficiency of the product development process. For regulatory bodies, reliable test results from this chamber can help streamline the approval process, reducing the time and resources spent on repeated evaluations.
The medical device industry is governed by strict international and national standards and regulations regarding product safety, performance, and quality. Our two - zone hot - cold shock test chamber is designed to help manufacturers and regulatory bodies ensure that medical devices meet these standards. By conducting comprehensive hot - cold shock tests in accordance with relevant medical standards, such as ISO 13485 (Medical devices - Quality management systems - Requirements for regulatory purposes) and various national regulatory requirements, manufacturers can demonstrate compliance and gain regulatory approval more easily. Meeting these standards is essential for market access and maintaining the trust of healthcare providers and patients.
In a highly competitive medical device market, offering reliable and high - performing products gives manufacturers a significant competitive edge. By using our custom two - zone hot - cold shock test chamber to conduct in - depth and comprehensive testing, companies can differentiate their products from competitors and showcase their commitment to quality and patient safety. Healthcare providers and hospitals are increasingly demanding medical devices that can perform well under a variety of temperature conditions, and by providing such devices, manufacturers can attract more business, increase market share, and strengthen their position in the industry.
- Pacemakers and Implantable Cardioverter - Defibrillators (ICDs): Test pacemakers and ICDs to ensure they can function properly under the temperature variations they may encounter inside the human body. These devices need to maintain their electrical and mechanical integrity to provide accurate and reliable cardiac support.
- Orthopedic Implants: Evaluate orthopedic implants such as hip and knee replacements. These implants must be able to withstand the body's normal temperature as well as any potential temperature changes during the surgical process and in the post - operative period.
- Blood Glucose Meters: Test blood glucose meters to ensure their accuracy and reliability under different temperature conditions. These devices are often used in various environments, and temperature can affect the chemical reactions and sensor performance.
- Ultrasound Machines: Evaluate ultrasound machines to ensure that their components, such as transducers and electronics, can operate properly under the temperature ranges they may encounter in different healthcare settings.
- Surgical Instruments: Test surgical instruments to ensure their durability and functionality under the temperature conditions during sterilization processes, which can be quite hot, and also during storage in cooler environments.
- Disposable Syringes and Needles: Evaluate disposable syringes and needles to ensure that the materials used maintain their integrity and safety under different temperature conditions during storage and transportation.
Our Custom Two - Zone Hot - Cold Shock Test Chamber for medical device products is a state - of - the - art testing solution that combines advanced technology, precision engineering, and user - friendly operation with a focus on security and hygiene. With its ability to simulate realistic thermal conditions, customize test profiles, and accommodate a wide range of medical devices, it provides a crucial tool for ensuring the quality, reliability, and safety of medical devices. Whether you are a medical device manufacturer looking to enhance your product quality or a regulatory body aiming to ensure compliance with medical standards, our chamber is the ideal choice. If you are interested in learning more about our chamber or scheduling a demonstration, please contact us. Our team of experts is ready to assist you.
