Medical electrical equipment - Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment

Medical electrical equipment - Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment

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201.1   Scope, object and related standards

Clause 1 of the general standard 1 applies, except as follows:

201.1.1   Scope

Replacement:
This part of IEC 60601 applies to the basic safety and essential performance of low energy ionized gas haemostasis equipment hereafter referred to as me equipment.
Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.