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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Although many Class I medical devices are supplied with an equipotential point, most, if not all, medical devices require multiple ground bond tests to validate the connections of additional metal accessible parts on the enclosure. Enter IEC IEC Medical Electrical Equipment—recurrent test and test after repair of medical electrical equipment—defines the requirements of ensuring the in-service electrical safety of EM equipment and systems.
IEC requires a minimum test current of mA, either AC or DC, but when using a DC test current, the resistance must be tested in both polarities of the test current.
As a type-testing standard, the current IEC does not provide any guidance to standardizing test requirements once an item of ME equipment has passed the design phase. If the buzz at the recent RSNA annual meeting is any indication of market trends, the ultrasound sector is hotter….
The motivation for most test requirements is the need to comply with statutory legislation and meet public liability considerations.
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For example, the test limit for a Class I device including a power cable not exceeding 3 meters is mV. In 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 necessary needle deflection. Insulation between mains parts and ground—this ied is used to verify that the mains parts are adequately insulated from ground Class I or the enclosure Class II.
Provide an understanding of the 623553 of using the different tests available, in order to help them prepare the adoption of the IEC standard. The following are typical visual checks that should be made: This standard is also applicable to tests after repair. This standard contains tables with allowable values relating to different editions of IEC With modern electronics and digital technology, the use of higher test currents is regarded as no longer necessary—a fact recognized by IEC with its mA minimum current.
An Introduction to IEC 62353
Direct Leakage Method 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. The following test report forms are related: The alternative method is similar to a dielectric strength test at mains potential, using a current limited voltage source at mains frequency. 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.
The most widely used standard is IEC The main advantage of using the lec leakage method is that the ground conductor remains intact during the measurement, thus providing safer working conditions. The open 6253 voltage of the current source should not exceed 24V.
International standards for the development and manufacturing of medical devices put greater emphasis on risk assessment and analyses of data. As a result, there are stringent rules on the design of medical equipment to ensure that the patient and operator are not exposed to those currents that do not form part of the functional operation of the device.
Safety testing of medical devices: IEC 62353 explained.
Safety testing of medical devices: IEC explained.
Routine testing is not limited to safety testing and often includes the verification of correct functionality. However, higher test currents—of 10A or more—might potentially be destructive to parts of the device under test, which are connected to the protective ground but have a functional purpose, such as iev. Housing enclosure—look for damage, cracks, etc; Contamination—look for obstruction of moving parts, connector pins, etc; Cabling supply, applied parts, etc —look for cuts, wrong connections, etc; Fuse rating—check correct values after replacement; Markings and labeling—check the integrity of safety markings; and Integrity of mechanical parts—check for any obstructions.
IEC specifies three methods— direct, differential, and alternative—that can be used to determine the leakage of EM equipment. Once a medical device enters into service, a number of potential test scenarios arise, including: The applied part leakage test measures the RMS deriving from the combined patient connections within an applied part to ground and any conductive or nonconductive parts on ice enclosure.
In the 26353 of helping to guarantee safer practice and the repeatability of test measurements, IEC defines different types of leakage current tests—one for total equipment leakage and another for applied parts leakage currents. In all cases, when choosing uec 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.
Leakage measurements achieved using the alternative method are highly repeatable and provide a good indication of deterioration in the uec of the medical device under test. The test methods are: This second edition cancels and replaces the first edition of IEC published in