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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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. This was the basis for the introduction of IECthe newly published international standard for medical electrical equipment—recurrent test and ifc after repair of ME equipment.

After service and repair testing—carried out following a repair, adaptation, or product upgrade. In meeting these aims, IEC incorporates tests beyond those of type testing.

The electrical safety testing of ME equipment is a crucial part of the overall safety validation 6353 medical devices and requires specialized test equipment. 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.

Safety testing of medical devices: IEC 62353 explained.

Another disadvantage is that secondary ground connections will produce a lower reading, thus potentially allowing faulty equipment to pass the test. This standard is not applicable to the assembly of ME systems. Appendix This contains reference tables for pass irc limits, standards, and documentation templates. By using this site, you are accepting our terms and conditions.

Safety testing of medical devices: IEC explained.

Published on September 7, Once a medical device enters into service, a number of potential test scenarios arise, including:. Acceptance testing, also referred to as initial or reference testing. It is often part of a service carried out by in-hospital mechanical or clinical engineering teams. IEC Leakage Testing Research has shown that it is current rather than voltage that is the source of electricity-related injuries and deaths.


In addition, this measurement is only taken in a single polarity and is similar to a dielectric test at mains 623353 using a current limited mains frequency supply. 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 leakage current.

Once a medical device enters into service, a number of potential test scenarios arise, including: The direct leakage method included in IEC is the same as that in IECmeasuring the true leakage through a body model measuring kec to ground.

This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems.

Importantly, the new standard recognizes that the laboratory conditions described in IEC cannot always be guaranteed irc in-service testing of medical devices is undertaken.

Clearly, safety testing at the design stage and at the end of the production line are vitally important, but what about when the equipment enters service? 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.

The main advantage of using the differential leakage method is that the ground conductor remains intact during the measurement, thus providing safer working conditions.

Free Guide to IEC 62353

This standard contains tables with allowable values relating to different editions of IEC 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. Record Keeping This section covers gathering and comparison of data collected, including what information should be included in the data logged.

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.


This standard is also applicable to tests after repair. The highest test reading will determine the pass or fail result of this test in comparison with different test limits included in IEC for different types of equipment.

The assumption was made that higher currents could best detect any damaged conductors present. This booklet is written as a guideline for people involved in testing medical electrical equipment ME equipment.

Please provide your name and email to continue. The motivation for most test requirements is the need to comply with statutory legislation and meet public liability considerations. Do you need a multi-user copy? Research has shown that it is current rather than voltage that is the source of electricity-related injuries and deaths. 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 disadvantages of using the alternative method are that measurements cannot be compared with previous IEC tests, and those active parts of the circuitry that require mains potential between live and neutral cannot be tested for possible leakage. The aim of this booklet is to help the reader to: All patient connections of a single function within an applied part shall be connected together BF and CF and measured one at a time. 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.

The test methods are: 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. We accept all major credit cards American Express, Mastercard and VisaPayPal and bank transfers as form of payment.

Three different insulation test methods are recommended for different types of ME equipment.