AS 60601.2.19:2018 pdf free

AS 60601.2.19:2018 pdf free.Medical electrical equipment
With the microphone of a sound level meter complying with the requirements of IEC 61672-1 [5] positioned 100 mm to 150 mm above the centre of the INFANT tray, the measured sound level shall not exceed the specified values. For this test the INFANT INCUBATOR shall be operated at a CONTROL TEMPERATURE of 36 °C and at a maximum humidity. The background sound level measured inside the COMPARTMENT shall be at least 10 dB below that which is measured during the test.
Audible ALARM SIGNALS shall have a sound level of at least 65 dBA at a distance of 3 m perpendicular to the front of the control unit in a reflecting room. The auditory alarm may be adjusted by the OPERATOR to a minimum lower level of 50 dBA. If the frequency of the auditory alarms is adjustable by the OPERATOR, these requirements shall apply to all the individual selectable frequencies.
Compliance is checked by inspection and measurement of the audible alarm level using a sound level meter, as required in subclause 201.9.6.2.1. 101 of this particular standard, placed 1,5 m above the floor and 3 m from the control unit. For this test the INFANT INCUBATOR shall be operated at a CONTROL TEMPERATURE of 36°C and at a maximum humidity. The background sound level measured shall be at least 10 dBA below that which is measured during the test.
When any INFANT INCUBATOR alarm is sounding, the sound level in the COMPARTMENT shall not exceed 80 dBA. If the frequency of the auditory alarms is adjustable by the OPERATOR, this shall apply to all the individual selectable frequencies.
The INFANT shall be safely retained within the COMPARTMENT by barriers such as walls or side panels. Barriers intended to be opened or removed to allow access to the INFANT, such as doors, ports etc., shall close So as not to open under the test conditions specified below. It shall not be possible for barriers to be insecurely closed or latched whilst appearing to be engaged. The mechanical integrity of the INFANT INCUBATOR shall be maintained under the following test conditions.AS 60601.2.19 pdf free download.