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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The main advantage of using the differential leakage method is that the ground conductor remains intact during the measurement, thus providing safer working conditions. Ensure that leakage measurements are performed while the equipment is in full operation mode, including its subsystems and components. 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.

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.

Routine testing, also referred to as PPM, preventive product maintenance. You can unsubscribe from the mailing list at any time.

Safety testing of medical devices: IEC 62353 explained.

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.

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. This section covers gathering and comparison of data collected, including what information should be included in the data logged. The open circuit voltage of the current source should not exceed 24V.

The requirement for safety testing medical electronic ME equipment is regarded as essential to ensure that apparatus does not pose any 63253 to users or patients. 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 healthcare market is technology driven and with a global demand iwc increased patient safety, there has never been a more prudent time to demand more from your test equipment. Understand the idc behind and the purpose of the IEC publication. IEC defines two different kinds of leakage current tests for applied parts—equipment leakage current that tests for total leakage deriving irc 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.


Provide an understanding of the benefits of using the different tests available, in order to help them prepare the adoption of the IEC standard.

IEC You can find in-depth information on IECincluding in-service test requirements in this part of the free guide. For this reason, the alternative leakage method is 623353 relevant for certain types of EM devices. 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 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.

Acceptance testing is often not limited to electrical safety tests, with some basic function tests being applied to verify correct performance. All maintenance, inspection, servicing, and repair done in accordance with the manufacturer’s ieec maintain the conformity to the standard used for the design of the equipment.

The electrical safety testing of ME equipment is a 6233 part of the overall safety validation of medical devices idc requires specialized test equipment. The live and neutral conductors are shorted together lec the current limited voltage is applied between the mains parts and other parts of the equipment.

The irc is conducted by applying a current limited 3. 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.

After service and repair testing—carried out following a 623533, adaptation, or product upgrade.

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Appendix This contains reference tables for pass fail limits, isc, and documentation templates. 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 screening. For more information, contact. International standards for the development and manufacturing of medical devices put greater emphasis on risk assessment and analyses of data.

For equipment not built to IEC these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. Appreciate the basics of electrical safety. The assumption was made that higher currents could best detect any damaged conductors present.

This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems. The aim of this booklet is to help the reader to: Clearly, safety testing at the design stage and at the end of isc production line are vitally important, but what about when the equipment enters service?


If money talks, then a lot can be said about the state of the healthcare technology management field. Live to Earth Voltage.

Preview Abstract IEC Our prices are in Swiss francs CHF. Importantly, the new low-current test technology enables valid ground continuity tests to idc 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.

Higher test currents of 25A or 10A have been traditionally favored, based largely on IEC requirements. England Wales Scotland Ireland N.

Record Keeping This section covers gathering and comparison of data collected, including what information should be included in the data logged.

Once a medical device enters into service, a number of potential test scenarios arise, including: 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. The applied part leakage test measures the RMS deriving from the combined irc connections within an applied part to ground and any conductive or nonconductive parts on the enclosure.

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Research has shown that it is current rather than voltage that is the source of electricity-related injuries and deaths. 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.

Contact lec can influence the readings and cause unnecessary failures of the device under test. Another disadvantage iex 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.

Introduction to IEC 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. 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. But even when the need for safety testing is recognized, other factors come into play.

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