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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Do you need a multi-user copy? Introduction to IEC 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.

Leakage measurements achieved using the alternative method are highly repeatable and provide a good indication of deterioration in the dielectrics of the medical device under test.

Earth Bond Testing Earth bond test considerations and precision vs accuracy are discussed in this section. Keeping It Safe Follow this checklist for safety testing and keep all the bases covered. By submitting your details you agree to our Privacy Policy.

This standard contains “general requirements”, which contain clauses of general concern, and “particular requirements”, further clauses handling special types of ME equipment or ME systems and applying in connection with the “General requirements”.

As such, consideration should be given to the test current. The following test report forms are related: Some manufacturers might specify full-scale accuracy, which will affect the accuracy of low-leakage measurements. 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.

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. 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 future use.


England Wales Scotland Ireland N. Recently, new test technology has been pioneered in the form of a new low-energy, high-current test that overcomes the previous contact-resistance problems that inhibited the wider application of protective ground testing using 1A or mA test currents. Once a medical device enters into service, a number of potential test scenarios arise, including: Testing Times Each part of the medical device market has different electrical safety testing requirements.

Understand the reasons behind and the purpose of the IEC publication. By using this site, you are accepting our terms and conditions. Although the onus will remain on the manufacturers of medical devices to advise on appropriate tests for their equipment, the new standard will 6253 have a significant impact uec medical service companies and clinical engineering, EBME, medical physics, and other technical departments.

In all cases, when choosing a suitable electrical safety analyzer, care should be taken to ensure that it can 6233 used to test in accordance with IEC requirements and that it is capable of performing accurate and repeatable test routines. 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.

Contact resistance can influence the readings and cause unnecessary failures of the device under test. For equipment not built to IEC these requirements may be used taking into account the 6353 standards for the design and information in the instructions for use of that equipment.

An Introduction to IEC – 24×7 Magazine

Routine testing is not limited to safety testing and often includes the verification of correct functionality. But even when the need for safety testing is recognized, other factors come into play.


The test methods are: Each part of the medical device market has different electrical safety testing requirements.

The healthcare market is oec driven and with a global demand for increased patient safety, there has never been a more prudent time to demand more from your test equipment. Three different insulation test methods are recommended for different types of ME equipment. Please provide your name and email to continue. Sentinel Event Alert 60—Developing a reporting culture: The open circuit voltage of the current source should not exceed 24V.

An Introduction to IEC 62353

These are called leakage currents. This booklet is written as a guideline for people involved in testing medical electrical equipment ME equipment. This standard is not applicable to the assembly lec ME systems. 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 edition constitutes a technical revision including the following main revisions: The test methods are:. The introduction of IEC is intended to streamline this position and harmonize all standards that aim to control the safety of electromedical EM devices 62335 in the treatment, care, and diagnosis of patients. IEC You can find in-depth information on IECincluding in-service test requirements in this part of the 662353 guide.

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. If the buzz at the recent RSNA annual meeting is any indication of market trends, the ultrasound sector is hotter….