AS/NZS IEC 60601.1.3:2015 pdf download-Medical electrical equipment Part 1.3: General requirements for basic safety and essential performance— Collateral Standard: Radiation protection in diagnostic X-ray equipment.
5.2.4 Instructions for use Additionally to the requirements of the general standard the following applies. 5.2.4.1 General requirements for RADIATION dose information The instructions for use shall contain all the information specific to the EQUIPMENT allowing the user to minimize the possibility of exposing PATIENTS to RADIATION dose levels where deterministic effects may occur during the NORMAL USE of the EQUIPMENT , to optimise the RADIATION dose delivered to the PATIENTS and to minimize the IRRADIATION of the OPERATORS . 5.2.4.2 Quantitative information For each INTENDED USE of the EQUIPMENT , the following information shall be provided: ? the RADIATION QUANTITY (or quantities) used for describing the RADIATION dose to the PATIENT . This quantity must be useful for assessing the RADIATION RISK to the PATIENT . NOTE Such quantities are, for example, the ENTRANCE SURFACE dose (or dose rate), the DOSE AREA PRODUCT or the CTDI vol . ? the description of a specified test object representative of an average PATIENT ; ? the specified procedure allowing measurement of the RADIATION QUANTITY (or quantities) for the specified test object; ? the value of the specified RADIATION QUANTITY (or quantities) when the specified test object is used to simulate a PATIENT when performing a procedure typical of this INTENDED USE ; ? the influence of the main adjustments or selections available to the OPERATOR on the value of the specified RADIATION QUANTITY . NOTE Examples of such adjustments or selections are MODES OF OPERATION , LOADING FACTORS , FOCAL SPOT selection and FOCAL SPOT TO IMAGE RECEPTOR DISTANCE . I NTENDED USE should not be confused with NORMAL USE . While both include the concept of use as intended by the MANUFACTURER , INTENDED USE focusses on the medical purpose. NORMAL USE incorporates not only the medical purpose, but maintenance, service, transport etc.. Compliance is checked by inspection of the instructions for use.