IEC Standards for the Safety and. Efficacy of Medical Electrical Equipment . Introduction. It might, perhaps, be a little too self-evident to say that there is no. The new IEC standard for the in-service and post repair testing of electromedical devices introduces new requirements. These and their. STANDARD. IEC. CEI. NORME. INTERNATIONALE. First edition. Première édition. Medical electrical equipment –. Recurrent test and test after.

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Free Guide to IEC 62353

Earth Bond Testing Earth bond test considerations and precision vs accuracy are discussed in this section. The ground bond test proves the integrity of the low-resistance connection between the ground conductor and any metal conductive parts, which may become live in fault situations with Class I medical devices.

In many cases, more rigorous electrical safety testing is needed after the replacement of components or reconfiguration of medical devices. One example is the culture of organizations, which can affect the type of test equipment used and the frequency of testing.

It is often part of a service carried out by in-hospital mechanical or clinical engineering teams. Insulation between applied parts and ground—this test is used to verify that the applied parts are adequately insulated from ground Class I or the enclosure Class II. The open circuit voltage of the current source should not exceed 24V. The differential test method measures the leakage current as a result of imbalance in current between the live and neutral conductors. Insulation between mains parts and ground—this test is used to verify that the mains parts are adequately insulated from ground Class I or the enclosure Class II.

In the interests of helping to guarantee safer practice and the repeatability of test measurements, IEC defines different types of leakage current 6235 for total equipment leakage and another for applied parts leakage currents. Appendix This contains reference tables for pass fail limits, standards, and documentation templates.


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Measurements can also be influenced by the presence of magnetic fields—the principle of measuring differential current—and measurements must be done in both directions to identify the worst-case scenario.


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622353 addition, when analog instruments were widely used for low-resistance measurement, it was often necessary to use high-test currents to produce sufficient voltage drop across the sample to generate the ifc needle deflection.

For equipment not built to IEC these requirements may be used taking into account the safety standards for the design and information in 622353 instructions for use of that equipment. You can find in-depth information on IECincluding in-service test requirements in this part of the free guide. Do you need a multi-user copy? Importantly, the new low-current test technology enables valid ground continuity tests to be carried out using battery-powered testers, significantly increasing the portability and versatility of handheld safety analyzers used in in-service safety testing routines, significantly speeding up the testing process.

This standard is also applicable to tests after repair. On the other hand, low-test currents—of less than 8A—may not always overcome problems associated with contact resistance caused by constriction, pressure, or film resistance factors, and may therefore show a relatively higher reading than there is and indicate unnecessary failures. For the purpose of this standard, the application of uec methods is independent of the edition according to which the ME equipment or ME system is designed.

Ensure that the operator of safety test equipment is properly trained on both the safety analyzer and the device under test to prevent unneccessary danger during the safety test.

This section covers gathering and jec of data collected, including what information should be included in the data logged. When determining the correct means of testing a specific medical device, ensure that the chosen safety test procedures are applicable to the device under test and are clearly documented for 6253 use.

An Introduction to IEC – 24×7 Magazine

For more information, contact. Insulation between applied part and mains—this test is used to verify that the applied parts are adequately insulated from the mains parts and is applicable to Class I and Class II BF eic CF equipment only. Higher test ie of 25A or 10A have been traditionally favored, based largely on IEC requirements. The main advantage of using the alternative method included in IEC is that the device under test is not connected to the mains supply and provides the safest possible test conditions for the operator.


The IEC equipment leakage can be performed using a direct, differential, or alternative method. Another factor can be the environment in which testing is undertaken, which can vary from the production line, the laboratory, an operating theater, lec the patient ward. Learning from close calls and hazardous conditions explores guidance for healthcare organizations and….

The direct method does therefore require a fully isolated device under test and must be performed on a terre neutral supply and in each polarity of the incoming mains supply to guarantee measurements are taken at the maximum potential ief current. The direct leakage method included in IEC is the same as that in IECmeasuring the true leakage through a body model measuring device to ground.

For example, the test limit for a Class I device including a power cable not exceeding 3 meters is mV. But even when the need for safety testing is recognized, other factors come into play. Three different insulation test methods are recommended for different types of ME equipment.

Idc all cases, when choosing a suitable electrical safety analyzer, care should be taken to ensure that it can be used to test in accordance with IEC requirements and that it is capable of performing accurate and repeatable test routines. Importantly, the new standard recognizes that the laboratory conditions described in IEC cannot always be guaranteed when in-service testing of medical devices is undertaken.

Routine testing is not limited to safety testing and often includes the verification of correct functionality. This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems.

Figures 4 and 5 provide a schematic representation of the applied part leakage test on Class I grounded ME equipment. Ensure that leakage measurements are performed while the equipment is in full operation mode, including its subsystems and components. Ensure high accuracy and repeatability of leakage measurement readings. As far as possible, it is an attempt at standardizing the safe operation and testing of ME equipment, while respecting specific local requirements and meeting increasing demands for risk management.