AS 60601.2.20:2018 pdf free download – Medical electrical equipment
Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601 -1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201 ” (e.g. 201 .1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601 -1 -2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601 -1 -3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201 .1 01 . However, due to the fact that definitions in the general standard are numbered 3.1 through 3.1 39, additional definitions in this standard are numbered beginning from 201 .3.201 .
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 TRANSPORT INCUBATOR shall be operated at a CONTROL TEMPERATUR e of 36 °C and at a maximum humidity. The background sound level measured inside the COMPARTMENT shall be at least 10 dBA below that which is measured during the test.
201 .9.6.2.1 .1 02 * Audible alarms sound level
Auditory 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 dB measured with the range setting of an A-weighted scale. 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 201.12.3.104 of this particular standard, placed 1,5 m above the floor and 3 m from the control unit. For this test the TRANSPORT 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 dB(A) below that which is measured during the test.