IEC 62353 PDF

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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Insulation between applied parts and ground—this test is used to verify ice the applied parts are adequately insulated from ground Class I or the enclosure Class II.

An Introduction to IEC – 24×7 Magazine

Another disadvantage is that secondary ground connections will produce a lower reading, thus potentially allowing faulty equipment to pass the test. Ensure that leakage measurements are performed while the equipment is in full operation mode, including its subsystems and components. Published on September 7, Differential measurement of leakage also does not require an isolated device under test because it relies on comparing the difference in current between the live and neutral conductors to measure the complete leakage of the device being tested, including leakage caused by secondary connections.

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.

Once a medical device enters into service, a number of potential test scenarios arise, including:.

Free Guide to IEC 62353

To meet this need, many different standards have been published to describe what is considered safe for the patients and operators of ME equipment. The aim of this booklet is to help the reader to: Live to Earth Voltage.

Learning from close calls and hazardous conditions explores guidance for healthcare organizations and…. The assumption was made that higher currents could best detect any damaged conductors present.

Three different insulation test methods are recommended for different types of ME equipment. In the interests 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 meeting these aims, IEC incorporates tests beyond those of type testing. Specifically, it seeks to provide a uniform and unambiguous means of assessing the safety of medical equipment, while maintaining the relation to IECand minimizing the risks to the person conducting the assessment. If the buzz at the recent RSNA annual meeting is any indication of market trends, the ultrasound sector is hotter…. 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.


Do you need a multi-user copy? 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 and CF equipment only. So, there is an increased need for test equipment that allows the user to automate data capture and ensure validity of test results for better management of risk.

Acceptance testing is often not limited to electrical safety tests, with some basic function tests being applied to iwc correct performance. Higher test currents of 25A or 10A have been traditionally favored, based largely on IEC requirements. The differential test method measures the leakage current as a result of imbalance in current between the live and neutral conductors.

This was the basis for the introduction of IECthe newly published international standard for medical electrical equipment—recurrent test and test after repair of ME equipment. As such, consideration should be given to the test current. One example is the culture of organizations, which can affect the type of test equipment used and the frequency of testing.

This standard is not applicable to the assembly of ME systems. This edition constitutes a technical revision including the following main revisions: For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. Although visual inspection is not clearly defined in IECits inclusion is a fundamental requirement of all routine test and maintenance procedures.

But even when the need for safety testing is recognized, other factors come into play. This second edition cancels and replaces the first edition of IEC published in By submitting your details you agree to our Privacy Policy.

An Introduction to IEC 62353

For more information, contact. Figures 4 and 5 provide a schematic representation of the applied part leakage test on Class I grounded ME equipment. In-Service Test Requirements 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.

The test methods are:. It is often part of a service carried out by in-hospital mechanical or clinical engineering teams. Provide an understanding of the benefits oec using the different tests available, in order to help them prepare the adoption of the IEC standard.

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. In 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.


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 the enclosure.

Please provide your name and email to continue. IEC You can find in-depth information on IECincluding in-service test requirements in this part of the free guide. IEC defines two different idc of leakage current tests for applied parts—equipment leakage current that tests for total leakage deriving from the applied parts, enclosure, and mains parts combined to real ground; and applied part leakage current that checks for total leakage deriving from the combined patient connections within an applied part to ground and any conductive or nonconductive parts on the enclosure.

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. As a result, there are stringent rules on the design 6233 medical equipment to ensure that the patient and operator are not exposed to those currents ie do not form part of the functional operation of the device.

Routine testing 6253 not limited to safety testing and often includes the verification of correct functionality. 6235 conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. The requirement for safety testing medical electronic ME equipment is regarded as essential to ensure that apparatus does not pose any danger to users or patients. 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.

After service 63253 repair testing—carried out following a repair, adaptation, or product upgrade. The IEC equipment leakage can be performed using a direct, differential, or alternative method. Although the onus will remain on the manufacturers of medical devices to advise on appropriate tests for their equipment, the new standard will clearly have a significant impact on medical service companies and clinical engineering, EBME, medical physics, and other technical departments.

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.