Medical Electrical Testing
Electrical safety testing in general is essential to ensure safe operating functions for any product that uses electrical power. Various governments and other agencies have developed stringent requirements for electrical products that are sold across the world. In most of the countries, it is mandatory for a medical devices operated on electricity to conform to safety standards implemented by regulatory agencies. To conform to such standards, the product must pass safety parameters. The current scope of Safety Testing includes Input Power; Marking & Instructions; Determination of Accessible Parts; Potential Equalization; Surface Coating; Protective Earthing; Functional Earthing; Leakage Current & Patient’s Auxiliary Current; Plugs & Sockets; Resistance to Environmental Stress; Dielectric Strength; Accessible Parts including Applied Part; Functional Earth Terminals; Creepage Distances & Air Clearance; Overflow, Spillage, Leakage Ingress of Water on Particular Matter,Cleaning,Disinfection,Sterilization and Compatibility with Substances used with ME Equipments.
Testing Parameters :-
Accuracy of Controls and Instruments and protection against Hazardous |
Classification of applied Parts |
Classification of ME Equipment and ME System |
Components and Wiring |
Construction of ME Equipment |
Constructional Requirements of Fire Enclosure of ME Equipment |
Creepage Distance and air Clearance |
Excessive Temperature in ME Equipment |
Fire Prevention |
Hazardous Situations and fault conditions for ME Equipment |
Hazards associated with moving Parts
Hazards Associated with Support System |
Hazards Associated With Surface Corners and edges |
Instability Hazards |
Insulation |
Limitation of Voltage Current of Energy |
ME Equipment Identification Marking and Documents |
Mechanical Hazards of Me Equipment |
Protection Against electrical Hazards from ME Equipment |
Protection Against Excessive Temperature and other Hazards |
Protection Against Mechanical Hazards of ME Equipment and ME System |
Requirement Related to power Sources |
Separation of Parts |
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