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The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
Testing method is specified in IEC standard 60112 and ASTM D3638. To measure the tracking, 50 drops of 0.1% ammonium chloride solution are dropped on the material, and the voltage measured for a 3 mm thickness is considered representative of the material performance. Also term PTI (Proof Tracking Index) is used: it means voltage at which during ...
An insulation resistance test (IR test) measures the electrical resistance of insulation by applying a voltage between two locations, and measuring the resultant current flow. Proper safety precautions must be taken when doing this test, such as exclusion zones, making sure no wires are exposed, and personal protective equipment is worn.
IEC 62057-1 Electrical energy meters – Test equipment, techniques and procedures – Part 1: Stationary meter test units (MTUs) IEC 62057-3 Electrical energy meters – Test equipment, techniques and procedures – Part 3: Automatic meter testing system (AMTS) IEC 62058 Electricity metering equipment (AC) – Acceptance inspection
Medical devices can and do take advantage of power entry modules. Power entry modules are available with electromagnetic interference filters with very low leakage current ratings, even those suitable for direct patient contact in accordance with UL 544 and IEC 60601-1. Shock-safe fuseholders have also been integrated into power entry modules.
Conformation to the requirements of applicable standards and guidelines, in particular the IEC 60601-1 standard, involves manufacturers themselves declaring CE compliance and/or gaining certification from an approved independent testing laboratory. The number of MOPPs a network isolator provides will be stated in the certification of the device.
Product specific tests are instead defined in standards such as EN 50130-4 for alarm systems, EN 50121-4-2 for railway applications or IEC 60601-1-2 for medical equipment. The product, or equipment under test (EUT), is seen from an operator's point of view during test. The EUT is therefore in its operational mode and testing does not include ...
The test is a means to qualify a device's ability to operate safely during rated electrical conditions. [1] If the current through a device under test is less than a specified limit at the required test potential and time duration, the device meets the dielectric withstand requirement.