This International Standard applies to the basic safety<\/small> and essential performance<\/small> of medical electrical equipment<\/small> and medical electrical systems<\/small>, hereafter referred to as me equipment<\/small> and me systems<\/small>.<\/p>\n
This collateral standard applies to X-ray equipment<\/small> and to subassemblies of such equipment, where radiological images<\/small> of a human patient<\/small> are used for diagnosis, planning or guidance of medical procedures.<\/p>\n
1.2<\/b> Object<\/p>\n
The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.<\/p>\n
The object of this collateral standard is to establish general requirements for protection against X-radiation<\/small> in X-ray equipment<\/small>, in order that the irradiation<\/small> of the human patient<\/small>, the operator<\/small>, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the radiological<\/small> procedure. Particular standards may specify their appropriate values and\/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the risk management<\/small> process.<\/p>\n
This collateral standard considers radiation protection<\/small> aspects related to X-radiation<\/small> only.<\/p>\n
Requirements for the control of the electrical energy used to generate X-radiation<\/small>, which is also an important aspect of radiation protection<\/small>, are included in IEC 60601\u20111 and in particular standards for the safety and essential performance<\/small> of the equipment<\/small> concerned.<\/p>\n
1.3<\/b> Related standards<\/p>\n
1.3.1<\/b> IEC 60601\u20111<\/p>\n
For me equipment<\/small> and me systems<\/small>, this collateral standard complements IEC 60601\u20111.<\/p>\n
When referring to IEC 60601\u20111 or to this collateral standard, either individually or in combination, the following conventions are used:<\/p>\n
“the general standard” designates IEC 60601\u20111:2005+A1:2012+A2:2020;<\/p>\n<\/li>\n
“this collateral standard” designates IEC 60601\u20111\u20113:2008+A1:2013+A2:2021;<\/p>\n<\/li>\n
“this standard” designates the combination of the general standard and this collateral standard.<\/p>\n<\/li>\n<\/ul>\n
1.3.2<\/b> Particular standards<\/p>\n
A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.<\/p>\n
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| 10<\/td>\n | Annex ZA (normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment<\/b><\/p>\n |