
Scope of Application
This standard is applicable to the safety of medical electrical equipment (as defined in 2.2.15) p> Although the wooden standard mainly involves safety issues, it also includes some requirements for reliable operation related to safety p> The safety hazards caused by the expected physiological effects of the equipment covered by this standard have not been considered p> Unless explicitly stated in the main text of the standard, the appendix content in the standard does not require mandatory execution p>
Purpose
The purpose of this standard is to specify the general safety requirements for medical electrical equipment and serve as the basis for the safety specific requirements standards for medical electrical equipment.
p>Special standards
Special standards take precedence over this general standard.
p>Environmental conditions
See Chapter 2.
p> &Nbsp&Nbsp&Nbsp; Parallel standards
In the series of standards for medical electrical equipment, parallel standards stipulate that general safety requirements should apply to:
- a group of medical electrical equipment (such as radiation equipment);
- a characteristic (such as electromagnetic compatibility) of all medical electrical equipment that is not fully stated in the general safety standards p> If a parallel standard is applicable to a specific standard, the specific standard takes precedence over the parallel standard p>
Terms and Definitions
The following terms and definitions in this standard apply p>
- "Voltage" and "current" refer to the effective values of AC, DC, or composite voltage or current p>
- The auxiliary verb
"should" refers to a requirement or experiment that should be enforced in accordance with this standard p>
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