AS NZS IEC 60601.1.3:2015 pdf free download.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 EOUIPMENTN) 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,
— that they can be identified readily and correlated with the ACCOMPANYING DOCUMENTS:
— 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.AS NZS IEC 60601.1.3 pdf download.