IEEE C63.18-1997 pdf download American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to SpeciÞc Radio- Frequency Transmitters
If possible, perform the ad hoc RF immunity test in a location that meets the test facility requirements of IEC 61000-4-3 (1995-03) (see Annex A). If such a facility is not available, the test should be performed in an area free of structures and metallic objects that extends at least 3 m (10 ft) 1 beyond the initial test distance on each side of the medical device and its attached cables, when arranged as speciÞed in 6.2. Thus, for transmit- ters up to 8 W, at least 9 m x 9 m (30 ft x 30 ft) of clear area is recommended. The test area should be in a basement location, if possible. When selecting an indoor test area, B.1.8 should be considered.
If no suitable indoor facility is available, the test can be performed in a vacant area of a parking lot. Staff members not participating in the test, visitors, and patients should be excluded from the test area during testing.
6.2 Placement of the medical device Place the medical device to be tested and its cables in the center of the clear area as shown in Figure 1, with the cables extended to the rear of the device. Cables that exit the front of the device should be routed over the top and to the rear. For cables longer than 3 m (10 ft), stretch out the Þrst 3 m (10 ft) from the device and bundle the remainder noninductively (i.e., in a serpentine, or ÒSÓ-shaped bundle). If the device is normally used on a table, place it on a nonconductive (e.g., wooden) table approximately 80 cm (31 in) high.
If the medical device is ßoor-standing, position it on the ßoor or ground. Support the cables approximately 40 cm (16 in) off the ßoor or ground using nonconductive objects (e.g., wooden or nonconductive plastic chairs or wastebaskets). The transition of the cable from the height of the medical device to a height of 40 cm (16 in) should be over as short a distance as possible. Medical device sensors should be placed next to the device, approximately 80 cm (31 in) off the ßoor or ground, and approximately even with the front panel or surface of the medical device as shown in Figure 1. If patient simulators are used, care must be taken to ensure that they are not affected by the RF transmitter and that they do not conduct RF energy into the medical device. The preferred method for avoiding the conduction of additional RF energy into the medical device is to use nonconductive means such as Þber optics to couple the simulated patient signals to the vicinity of the medical device sensors. If this type of coupling is not available, small, shielded, battery-operated simulators are recommended.
If patient simula- tors are found to be affected by the RF transmitters used, the test should be performed with the simulators located away from the test area, unless the method used to couple the simulator signals to the medical device sensors (e.g., cables) is found to affect the test results. If patient simulators must be in proximity to the sensors, they should be supported at a height of approximately 80 cm (31 in) and placed behind the sensors, as shown in Figure 1. If human volunteers must be used to provide patient signals during the test, institu- tional review board (IRB) approval should be obtained. 6.3 Evaluation of medical device performance With the RF transmitter off, establish and verify normal operation of the medical device. During the ad hoc RF immunity test, observe any abnormal operation. (See the following suggested list of response descrip- tions). After the RF immunity test is completed, verify that the medical device operates normally and was not damaged during the test.
IEEE C63.18-1997 pdf download
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