In the rapidly evolving landscape of modern healthcare, medical electrical equipment has become an indispensable part of the medical field. From commonly used patient monitors to sophisticated surgical instruments, these devices play a crucial role in disease diagnosis, treatment, and rehabilitation. However, as the complexity of medical devices continues to increase, safety incidents related to equipment failures are on the rise. These incidents not only pose significant threats to patient lives and health but also create potential risks for healthcare professionals. To ensure the safety of all stakeholders and standardize the market, the International Electrotechnical Commission (IEC) has developed and continuously refined the IEC60601-1 standard, which has emerged as the cornerstone of the medical electrical equipment industry, providing clear guidelines for device design, production, and operation.
The IEC60601-1 standard focuses on the essential safety and essential performance of medical electrical equipment and medical electrical systems. Through multiple revisions and updates since its initial release, it has incorporated expert opinions and practical experiences from around the world. It closely follows the trends of emerging technologies and actively addresses the ever - evolving safety challenges. In an era where medical devices are becoming increasingly intelligent and multifunctional, the significance of this standard has grown exponentially.
During the actual testing process, a range of specialized testing equipment is required in accordance with different clauses of the IEC60601-1:2020 standard to ensure that medical electrical equipment fully meets safety and performance requirements. The flowing table lists the testing equipment corresponding to the relevant clauses.
IEC60601-1: 2020 clause and figures | Corresponding to Pego’s testing equipment |
Clause 5.7 Humidity preconditioning treatment | High Temperature and Humidity Test Chamber |
Clause 5.9.2 Accessible parts |
Standard Test Finger (Clause 5.9.2.1, clause 8.9.4, clause 8.10.3, clause 8.11.1, Figure 6) Unjointed Test Finger (Clause 5.9.2.1) Test Hook (Clause 5.9.2.2 and clause 8.9.4, figure 7)
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Clause 6.3 Protection against harmful ingress of water or particulate matter | |
Clause 8.4.2 Accessible parts and applied parts (d) |
Test Pin (Figure 8, test probe 13) Metal Test Rod with diameter of 4mm and length 100mm (with 10N force) |
Clause 8.4.3 ME Equipment intended to be connected do a power source by a plug | Plug Pins Residual Voltage Tester |
Clause 8.7 Leakage currents and Patient Auxiliary currents | Medical Leakage Current Tester (Figure 12) |
Clause 8.8.3 Dielectric strength and table 6 | Medical Withstand Voltage Tester |
Clause 8.8.4.1 Mechanical Strength and resistance to heat |
Ball Pressure Test Apparatus (Figure 21) |
Clause 8.9.1.7 | Tracking Index Tester |
Clause 8.9.1.15 Creepage distances and air clearances for defibrillation-proof applied parts (Table 12-16) | Creepage Distances Test Card (30 sizes) |
Clause 8.11.3.5 Cord anchorage (Table 18) | Cord Anchorage Pull Force and Torque Tester |
Clause 8.11.3.6 Cord guards | Supply Cord Flexing Test Apparatus |
Clause 9.4.2.1 Instability in transport position | Incline Plane Tester |
Clause 9.5.2.4.3 Movement over a threshold | Threshold Obstruction |
Clause 9.4.4 Grips and other handing devices | Handle Strength Test Apparatus |
Clause 11.1.3 Measurements | Black Test Corner |
Clause 11.6.5 Ingress of water or particulate matter into ME equipment and ME systems | |
Clause 13.2.13.3 ME equipment with motors | Cheesecloth |
Clause 15.3.2 Push test | 30mm Circular Plane |
Clause 15.3.3 Impact test | Impact Test Device with a Steel Ball |
Clause 15.3.4 Drop test | Drop Impact Test Hardwood Board |
Clause 15.3.5 Rough handling test |
Ascending and Descending Step Shock Obstruction (a and b) Door Frame Shock Obstruction (c) |
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