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101
14.2.2
Notices Concerning the Inspection Plan
The inspection plan is based on the standards:
•
IEC 60601-1 “Medical electrical equipment – part 1: General requirements for basic safety, including the
essential performance characteristics
•
IEC 60601-2-41: “Particular Requirements for the Safety of Surgical Luminaires and Luminaires for
Diagnosis”.
•
IEC 62353 “Medical electrical equipment – Recurrent test and test after repair of medical electrical
equipment”
•
List each terminal and accessory device in the report, see “Inspection plan”.
•
Anything that is an add-on or deviates from the standards should be included under
Additional
information
. An example of an add-on would be: surgiCam® in the light head.
•
If a system SN is available, it must be listed under
Serial number/CN light system
.
•
Be sure to specify the
room/OR №
and
serial number
.