With the aging of the population steadily increasing, the demand for medical device industries to develop new health care and related auxiliary equipment are also increasing. Medical devices and related electronic equipment that are directly in contact to the human body poses electrical safety concerns and is an important topic that must be addressed in the design and production of medical electronic devices. To address these concerns, the International Electrotechnical Commission developed IEC 60601, a series of technical standards for the safety and effectiveness of medical electrical equipment. IEC60601 has become a requirement for the commercialization of electrical medical equipment in many countries.
Chroma’s 8900 Electrical Safety Automated Test System is compliant with the IEC60601-1 standard. In addition to basic AC and DC withstand voltage, insulation resistance, and ground bond tests, it provides four different types of dynamic leakage current tests; earth leakage current (ELC) test, enclosure leakage current (ECLC) test, patient leakage current (PLC) test and patient auxiliary leakage current (PALC) test. The Chroma 8900 is designed with an open architecture providing a flexible, expandable, and cost-effective test system with seamless integration with a wide range of commercial-off-the-shelf equipment. Automation allows the testing of everything at once and provides complete test data in order to improve test efficiency and satisfy the rigid test demands of medical devices.
Beijing PINS Medical Equipment (PINS) adopted Chroma’s 8900 Electrical Safety ATS in testing, producing, research and development of their neuromodulation products. Its deep brain stimulator has been granted CE certification, which is the first DBS product with CE marking in China.
Deep Brain Stimulator (DBS) and its Working Diagram (source: Beijing PINS)
Beijing PINS Medical Equipment Co. Ltd. is an innovative high-tech enterprise with a focus on neuromodulation, a variety of clinical products have been developed to date, which include stimulators for deep brain, vagus nerve, spinal cord and sacral nerve stimulation therapies. As part of the “National Engineering Laboratory for Neuromodulation”, PINS Medical works in close cooperation with Tsinghua University and the numerous affiliated clinical centers, becoming a center of attraction for a wide range of professional talents in areas of clinical research, innovative R&D and business management. PINS Medical has developed rapidly in becoming a leading brand in neuromodulation within the Chinese market, due to the success of its creative research platform that efficiency links basic research, R&D of innovative products, clinical testing and market entry.
Chroma Electronics (Shenzhen) Co., Ltd. is a subsidiary of the Chroma Group in Taiwan with products marketed globally under the brand name “Chroma”. With 30 years of experience in test and measurement instrumentation, Chroma is capable of creating innovative testing solutions for new energy-related industries including lithium battery, LED, solar energy, electric vehicles, smart grid and biotechnology. Chroma’s test solutions have been adopted by well-known manufacturers and testing laboratories all over the world.