1.1 Scope
This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems.
This collateral standard applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures.
1.2 Object
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.
The object of this collateral standard is to establish general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the radiological 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 process.
This collateral standard considers radiation protection aspects related to X-radiation only.
Requirements for the control of the electrical energy used to generate X-radiation, which is also an important aspect of radiation protection, are included in IEC 60601‑1 and in particular standards for the safety and essential performance of the equipment concerned.
1.3 Related standards
1.3.1 IEC 60601‑1
For me equipment and me systems, this collateral standard complements IEC 60601‑1.
When referring to IEC 60601‑1 or to this collateral standard, either individually or in combination, the following conventions are used:
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"the general standard" designates IEC 60601‑1:2005+A1:2012+A2:2020;
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"this collateral standard" designates IEC 60601‑1‑3:2008+A1:2013+A2:2021;
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"this standard" designates the combination of the general standard and this collateral standard.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.
