The IEC60601-1 standard is formulated by the International Electrotechnical Commission (IEC). It applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. The IEC 60601-1 standard, as the core specification in the field of medical electrical equipment, serves like a solid lighthouse, guiding the design, production, and use of equipment.
With the continuous advancement of medical technology, medical electrical equipment has become increasingly complex and widely used, and various safety accidents caused by equipment have occurred from time to time. To ensure the safety of patients and operators and standardize the market, the IEC has gradually improved this standard based on comprehensive professional opinions and practical experiences from multiple parties. From the initial version to the continuous revisions and updates today, it has been constantly adapting to emerging technologies and safety challenges.
The IEC60601-1 standard involves many testing equipment. 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 | |
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 | |
Clause 8.7 Leakage currents and Patient Auxiliary currents | Medical Leakage Current Tester (Figure 12) |
Clause 8.8.3 Dielectric strength and table 6 | |
Clause 8.8.4.1 Mechanical Strength and resistance to heat | Ball Pressure Test Apparatus (Figure 21) |
Clause 8.9.1.7 | |
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) | |
Clause 8.11.3.6 Cord guards | |
Clause 9.4.2.1 Instability in transport position | |
Clause 9.5.2.4.3 Movement over a threshold | Threshold Obstruction |
Clause 9.4.4 Grips and other handing devices | |
Clause 11.1.3 Measurements | |
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 | |
Clause 15.3.3 Impact test | |
Clause 15.3.4 Drop test | |
Clause 15.3.5 Rough handling test | Ascending and Descending Step Shock Obstruction (a and b) Door Frame Shock Obstruction (c) |
