YY 9706.233-2021 Medical electrical equipment—Part 2-33:Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Scope

This part of GB 9706 specifies the general requirements for the basic safety and basic performance of ME devices and ME systems.
This part applies to medical electrical equipment and medical electrical systems (hereinafter referred to as ME devices and ME systems).
If a chapter or a clause explicitly states that it only applies to ME devices or ME systems, the title and the body of the chapter or clause will indicate this. If this is not the case, the relevant chapter or clause applies to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
Replacement:
This part specifies the dedicated requirements for the basic safety and basic performance of medical diagnostic magnetic resonance equipment, and this part applies to medical diagnostic magnetic resonance equipment (hereinafter referred to as ME devices).
This part does not cover applications beyond the intended use of magnetic resonance equipment.
If a clause or sub-clause is specifically intended to apply only to ME devices or only to ME systems, the title and content of the clause or sub-clause will indicate this. Otherwise, the clause or sub-clause applies to both ME devices and ME systems.
This part does not cover the special requirements for the use of magnetic resonance equipment or magnetic resonance systems during interventional procedures.

Development Information

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