AS NZS IEC 60601.1.3:2015 pdf free
AS NZS IEC 60601.1.3:2015 pdf free.Medical electrical equipment
If there is a possibility in NORMAL USE that the PATIENT can be exposed to RADIATION dose levels where deterministic effects may occur, the instructions for use shall address this fact.In this case, the particular MODES OF OPERATION, configurations and circumstances in which deterministic effects may occur shall be listed and the following information shall be provided.
a) The instructions shall draw attention to the need to manage high RADIATION doses, and,when applicable, to the availability of selectable settings that can have a significant effect on the RADIATION QUALITY, the delivered RADIATION dose, AIR KERMA or AIR KERMA RATE and the image quality.
b) The number of EXPOSURES or the duration of LOADING necessary to reach levels where deterministic effects are possible on the specified average PATIENT and for obese PATIENTS shall be stated.
c) Information shall be provided concerning available settings of LOADING FACTORS, technique factors and operating parameters that affect the RADIATION QUALITY or the prevailing RADIATION dose (rate) in NORMAL USE.
Compliance is checked by inspection of the instructions for use.For each type of procedure where OPERATORS have to stay during NORMAL USE in SIGNIFICANT ZONES OF OCCUPANCY, the following information shall be provided:
a) the RADIATION dose resulting from the operation of the EQUIPMENT measured using a specified procedure;
b) means to reduce the RADIATION dose received by the OPERATOR， such as RADIATION PROTECTION provisions provided during installation of the EQUIPMENT, precautions in use,and adjustments of the EQUIPMENT settings;
c) a list of PROTECTIVE DEVICES and ACCESSORIES to be used for RADIATION PROTECTION. The listing may include PROTECTIVE DEVICES such as PROTECTIVE CLOTHING, recommended for use but not forming part of the EQUIPMENT.
When in NORMAL USE the termination of the LOADING STATE is determined by the EQUIPMENT,the termination shall be unambiguously indicated to the OPERATOR by an audible signal. Series of LOADING STATES initiated by a single actuation shall be considered as one LOADING for this requirement.AS NZS IEC 60601.1.3 pdf free download.
