AS NZS IEC 60601.1.3:2015 pdf free download – Medical electrical equipment Part 1.3: General requirements for basic safety and essential performance— Collateral Standard: Radiation protection in diagnostic X-ray equipment
5.2.4.4Clinical protocols
When clinical protocols are proposed by the MANUFACTURER, and preloaded on the EQuIPMENT,the instructions for use shall state if they constitute recommendations to be applied directly soas to allow optimized operation or if they are only examples/starting points, to be replaced bymore specific protocols developed by the user.
Compliance is checked by inspection of the instructions for use.
5.2.4.5* Deterministic effects (ICRP60)[17]
lf there is a possibility in NORMAL uSE that the PATIENT can be exposed to RADIATION doselevels 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 whichdeterministic 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 effecton the RADIATION QUALITY, the delivered RADIATION dose，AlR KERMA or AIR KERMA RATE andthe 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 PATIENTSshall be stated.
c) lInformation shall be provided concerning available settings of LOADING FACTORS, technique
factors and operating parameters that affect the RADIATION QUALITY or the prevailingRADIATION dose (rate) in NORMAL UsE.
Compliance is checked by inspection of the instructions for use.
5.2.4.6RIsK to OPERATORS
The instructions for use shall draw the attention of the user to the need to restrict access tothe EQUIPMENT in accordance with local regulations for RADIATION PROTECTION.
All information necessary to minimize the IRRADIATION of the oPERATORS in NORMAL uSE shallbe provided.
For each type of procedure where oPERATORs have to stay during NORMAL USE in SIGNIFICANTZONES 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 RADIATIONPROTECTION 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.Thelisting may include PROTECTIVE DEVICES such as PROTECTIVE CLOTHING，recommended for
use but not forming part of the EQUIPMENT.
Compliance is checked by inspection of the instructions for use.
6 RADIATION management
6.1General
X-RAY EQUIPMENT shall be so designed to enable the management of the delivery of x-RADIATION to the PATIENT in a safe and effective way. The measures required in subclauses6.3 to 6.7 are necessary to enable an acceptable dose-benefit balance to be achieved.
6.2 Initiation and termination of the lRRADIATION
6.2.1 Normal initiation and termination of the lRRADIATION
Each LOADING shall be initiated and maintained by means of a control requiring continuousactuation by the oPERATOR. lt shall be possible for the oPERATOR to terminate the LOADING atany time.
Any control by which the LOADING of an X-RAY TUBE can be initiated shall be protected againstunintended actuation using means compatible with the INTENDED uSE of the X-RAY EQUIPMENT.Compliance is checked by inspection and by the appropriate functional tests.
6.2.2Safety measures against failure of normal termination of the lRRADIATION
In the case of a failure of its normal termination，the lRRADIATION shall be terminated by asafety measure.
lf the normal termination of IRRADIATION is not effected on the basis of a RADIATIONmeasurement,continuous actuation by the oPERATOR(see 6.2.1) is sufficient as the safetymeasure.
The system for normal termination of lRRADIATION and the system used for the safety measureshall be separated so that a failure in one system does not affect termination by the othersystem.AS NZS IEC 60601.1.3 pdf download.