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.
4 General requirements
4.1 Statement of compliance
Any statement of compliance with the requirements of this collateral standard shall be given in the following form: xxxx with radiation protection in accordance with IEC 60601-1-3:2008, where xxxx represents the object (e.g. “X-RAY EQUIPMENT”) for which compliance is to be stated.
4.2 Composition of reference materials
Values of ATTENUATION EQUIVALENT, HALF-VALUE LAYER and QUALITY EQUIVALENT FILTRATION shall be expressed in this collateral standard as thicknesses of aluminium of purity 99,9 % or higher.
5 ME EQUIPMENT identification, marking and documents
5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts Additionally to the requirements in Clause 7 of the general standard, the following applies.
5.1.1 General
All subassemblies, components and ACCESSORIES of X-RAY EQUIPMENT that can be removed in NORMAL USE, and are relevant to compliance with this collateral standard, shall be marked to ensure,一that they can be identified readily and correlated with the ACCOMPANYING DOCUMENTS; 一that interchangeable devices are individually distinguishable to the OPERATOR both in NORMAL USE and for the purpose of obtaining replacements. All markings shall be permanently affixed and clearly legible as defined in Clause 7 of IEC 60601-1.
5.1.2 Marking requirements in subclauses
In this collateral standard particular requirements for marking and for the content of markings are given in various subclauses, as indicated in Table 1 .
5.2 ACCOMP ANYING DOCUMENTS
Additionally to the requirements of the general standard, the following applies.
5.2.1 References in subclauses
The subclauses of this collateral standard that contain requirements for statements in ACCOMPANYING DOCUMENTS (which include instructions for use and technical description) are listed in Table 2.
5.2.2 Dosimetric calibration
When dosimetric indications are provided on the EQUIPMENT, the ACCOMPANYING DOCUMENTS shall contain information and instructions on how to check and maintain the accuracy of dosimetric indications specified by the MANUFACTURER. Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
5.2.3 General requirements for the reference of subassemblies and ACCESSORIES
ACCOMPANYING DOCUMENTS shall clearly identify the items to which they refer and shall include:
— the replication of all information required in this collateral standard to be marked on the items;
— for subassemblies forming part of the items, the following information about the location and content of their required markings:
a) for markings accessible in the complete assembly, the location of the markings and instructions for enabling them to be inspected;
b) for markings inaccessible in the complete assembly, either
1) the replication of all information required in this collateral standard to be marked on the subassemblies; or
2) a list of the subassemblies concerned, with references to their own ACCOMPANYING DOCUMENTS. — For items, such as components and subassemblies, specified to be supplied separately from the main assemblies of which they are intended to form a part, technical descriptions with the information necessary to maintain their compliance with this collateral standard in the main assemblies concerned. Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
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 CTDI01. — 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. INTENDED 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..AS NZS IEC 60601.1.3 pdf download.
AS NZS IEC 60601.1.3:2015 pdf download
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