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With the development of modern societal infrastructure, hospitals have introduced a large number of advanced medical devices as part of their reform and upgrading efforts. These devices play a crucial role in daily clinical diagnosis and treatment. On one hand, they provide strong technical support for improving the quality and efficiency of hospital services; on the other hand, they effectively stimulate the growth of hospital revenues. However, the application of high-tech medical equipment also brings certain technical risks. The increasing safety hazards demand higher professional competence from medical staff.
Traditional hospital equipment maintenance centers can no longer meet the demands of modern medical device management. When technical issues arise, if the hospital’s maintenance team is unable to resolve them, decisions such as scrapping the equipment or sending it back to the manufacturer for repairs will inevitably increase costs. This, in turn, leads to higher medical risks and reduced economic efficiency.
Therefore, implementing appropriate quality control and management measures for medical equipment can effectively support the hospital’s financial growth while meeting societal expectations for healthcare development. Chinese medical institutions began exploring medical equipment quality management and control over 30 years ago. Today, some hospitals have established well-structured management processes and engineering teams to perform quality control, achieving remarkable results and becoming benchmark institutions in the field.
Compliance with Standards & Customer Needs
A hospital in Foshan is equipped with over 5,000 advanced medical devices, including a 256-slice iCT (Ultra-Fast CT), PET/CT, 3.0T MRI, large-bore 16-slice spiral CT, Varian Trilogy linear accelerator, Varian 23EX linear accelerator, and single-photon emission computed tomography (SPECT), with a total asset value of 650 million RMB.
The hospital’s Equipment Management Department is responsible for the procurement, supply, allocation, maintenance, and management of all medical instruments and devices. Its duties include organizing personnel for equipment acceptance, installation, debugging, training, and calibration, as well as conducting repairs and maintenance.
To further strengthen medical equipment quality control and ensure optimal performance, the department planned to purchase a batch of quality control testing devices. Given that the Seculife ST offers comprehensive electrical safety testing functions and supports high-voltage testing modules, the department ultimately selected the "Seculife ST + HV + 25A RPE + 125 Memory" configuration.
Multifunctional integration, compliant with common medical standards IEC 62353 and IEC 60601.
Fully automatic or manual testing modes, simplifying complex testing procedures.
Automatic detection of connection errors and insulation class (Class I/II).
Built-in help button for quick access to test explanations and schematic diagrams.
Supports integrated high-voltage testing.
Offers the only solution on the market capable of testing three-phase equipment.
Hospital Equipment Departments
Primarily for quality control, maintenance, and testing of active medical electrical equipment, focusing on IEC 62353, though many hospitals also consider IEC 60601.
(Success cases: Sir Run Run Shaw Hospital, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital of Zhejiang University, Changzheng Hospital, Shanghai Sixth People’s Hospital, Hefei CAS Ion Medical, and Foshan First People’s Hospital, etc.)
Testing Institutions
Provincial medical inspection centers, metrology systems, quality inspection institutes, and third-party certification agencies mainly follow IEC 60601. For type testing, AC withstand voltage tests are required, while for general commercial inspections, customer-commissioned maintenance tests, or capacitive equipment testing, DC withstand voltage is also acceptable.
(Success cases: Zhejiang Medical Inspection Institute, Shanghai Medical Inspection Institute, SGS, National Health Inspection Center, and Jiangsu Medical Inspection Institute, etc.)
Manufacturers
Factory testing must comply with IEC 60601, while after-sales service departments perform post-repair testing per IEC 62353.
