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 following test report forms are related: 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.
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 ice the test current. 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”.
Free Guide to IEC 62353
Record Keeping This section covers gathering and comparison of data collected, including what information should be included in the data logged. 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.
Please provide your name and email to continue. Live to Earth Voltage. The motivation for most test requirements is the need to comply with statutory legislation and meet public liability considerations. Three different insulation test methods are recommended for different types of ME equipment. In meeting these aims, IEC incorporates tests beyond those of type testing.
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.
Direct Leakage Method The direct leakage isc included in IEC is the same as that in IECmeasuring the true leakage through a body model measuring device to ground.
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. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed.
An Introduction to IEC – 24×7 Magazine
Keeping It Safe Follow this checklist for safety testing and keep all idc bases covered. 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.
Nowhere does this ring…. Published on September 7, International standards for the development and manufacturing of medical devices put greater emphasis on risk assessment and analyses of data. Insulation between mains parts and ground—this test is used to verify that the mains parts are adequately insulated from ground Class I or the enclosure Class II. Another factor can be the environment in which testing is undertaken, which can vary from the production line, the laboratory, an operating theater, to the patient ward.
Safety testing of medical devices: IEC explained.
Introduction to IEC As such, consideration should be given to the test current. Routine testing is not limited to safety testing and often includes the verification of correct functionality. This second edition cancels and replaces the first edition of IEC published in Ensure that the operator of safety test equipment is properly trained on both the safety analyzer and the device under test to prevent iex danger during the safety test.
IEC Leakage Uec Research has shown that it is current rather than voltage that is the source of electricity-related injuries and deaths.
If money talks, then a lot can be said about the state of the healthcare technology management field. The disadvantages of using the alternative method are that measurements cannot be compared with previous Iiec tests, and those active parts of the circuitry that require mains potential between live and neutral cannot be tested for possible leakage.
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. Provide an understanding of the benefits of using the different tests available, in order to help them prepare the adoption of the IEC standard. 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.
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.
It is often part of a service carried out by in-hospital mechanical or clinical engineering teams. IEC Ground Bond Test 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 booklet is written as a guideline for people involved in testing medical electrical equipment ME equipment. This standard is not applicable to the assembly of ME systems.
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. Understand the reasons behind and the purpose of the IEC publication.
Do you need a multi-user copy? 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. Routine testing, also referred to as PPM, preventive product maintenance. 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.
For example, the test limit for a Class I device including a power cable not exceeding 3 meters is mV. For more oec, contact.