Insulation Resistance Applied Parts to Mains. 8. IEC Leakage Measurements. Method Characteristics. Direct Leakage Provides. 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. 7 Sep IEC Medical Electrical Equipment—recurrent test and test after repair of medical electrical equipment—defines the requirements of.
|Genre:||Health and Food|
|Published (Last):||15 September 2008|
|PDF File Size:||5.66 Mb|
|ePub File Size:||2.58 Mb|
|Price:||Free* [*Free Regsitration Required]|
Requirements for special installations or locations — Medical locations Graphical symbols for use on equipment Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1: In all cases, when choosing a suitable electrical safety analyzer, care should be taken to ensure that iec 62353 can be used to test in accordance with IEC requirements and that it is capable of performing accurate and repeatable test routines.
Preview Abstract IEC For allowable values, refer to Table 2 or Annex E. It is often part of a service carried out by in-hospital mechanical or clinical engineering teams. The applied part leakage test measures iec 62353 RMS deriving from the combined iec 62353 connections within an applied part to ground and any conductive or nonconductive parts on the enclosure.
An Introduction to IEC 62353
Connection lines such as data lines or functional earth conductors may appear to act like protective earth connections. Examples of such equipment are: It also shall be ensured that they continuously adapt their knowledge to the current state iec 62353 the iec 62353.
In many cases, more rigorous electrical safety testing is needed after the replacement of components or reconfiguration of medical devices. An insulation resistance measurement may be helpful: The measurement equipment for the direct method shall: Acceptance iec 62353 is often not limited to electrical safety tests, with some basic function tests being applied to verify correct performance.
They are connected to the enclosure see figures and are Included by the measurement of the enclosure leakage current, with the same allowable values. IEC Medical Electrical Equipment—recurrent test and test after repair of medical electrical equipment—defines the requirements of ensuring the in-service electrical iec 62353 of EM equipment and systems.
Requirements for special installations or locations iec 62353 Medical locations lECGraphical symbols for use on equipment lECSafety requirements for electrical equipment for measurement, control and laboratory use – Part 1: The values for the resistance of the protective earth are covered by the requirement for a certain cross-sectional area of the relevant protective earth conductor in relation to the technical data of a fuse.
Each part of the medical device market has different electrical safety testing requirements. This standard iec 62353 not intended to define time intervals for iec 62353 tests. It was decided the values for alternative method should be twice the values of lEC even if in most cases the insulation is not symmetrical.
For legends, see Table 1 Figure 4 – Measuring circuit for iec 62353 measurement of equipment leakage current- direct method 5.
For equipment not built to IEC these requirements may be used taking into account iec 62353 safety standards for the design and information in the iiec for use of that equipment.
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 individual applied parts shall comply with the patient leakage current values. In meeting these iec 62353, IEC incorporates tests beyond those of type testing. iec 62353
Before lEC was published, some countries had idc for measuring the insulation of me equipment. NOTE 3 When measuring equipment leakage current of class i me equipment, iec 62353 attention needs to be paid as persons can be iec 62353 by an interrupt of the protective earth connection.
Insulation resistance measurements shall be performed with V d.
Safety testing of medical devices: IEC 62353 explained.
The selection of methods and materials should contribute in this way. The alternative method is similar to a dielectric strength test iec 62353 mains potential, using a current limited voltage source at mains frequency. For an example to test documentation, see Figure G.
NOTE 3 In some jurisdictions, the responsible organization can be considered a manufacturer when involved in the iec 62353 described. General requirements Safety requirements for electrical equipment for measurement, control and laboratory use — Part Although visual inspection is not clearly defined in Iec 62353its inclusion is a fundamental ieec of all routine test and maintenance procedures.
If measurements in different positions of the mains plug are appiicabie, the higher value shall be documented.
Download Your Free Guide to IEC from Rigel Medical Today
Once a medical device enters into service, a number of potential test scenarios arise, including: The highest value shall be documented. NOTE 2 For me systems, the responsible party, who has assembled the system, will define the necessary measurement settings and methods as required in lEC Keeping It Safe Follow this checklist for safety testing and keep all the bases covered.
Iec 62353 requirements I ECSafety requirements for electrical equipment for measurement, control 6253 laboratory use – Part In home iec 62353 applications, the patient, operator and responsible organization can be one and the same person. Equipment without leakage current will result in zero residual iec 62353 flow, as the current into the device and the current flowing iec 62353 are of equal value.
IEC You can find in-depth information on IECincluding in-service test requirements in this part of the free guide.
Safety testing of medical devices: IEC explained. – PubMed – NCBI
Test before putting into service reference value D Recurrent test D Name of testing person: 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 live and neutral conductors are shorted together and the current limited voltage is applied iec 62353 the mains parts and other parts of the equipment. Enter IEC IEC Medical Electrical Equipment—recurrent test and test after repair of medical electrical iec 62353 the requirements of ensuring the in-service electrical safety of EM equipment and systems.
Such iec 62353 cord could subsequently be used with class i equipment.
The main advantage of using the alternative method included in IEC is that the device under iec 62353 is not connected to the mains iec 62353 and provides the safest possible test conditions for the operator. General requirements oec all parts. NOTE 1 The manufacturer has to define in the instructions for use or other accompanying documents e. National legislations may require recurrent basic visual inspection in any case.