Medical Electrical Equipment

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 in Delhi Test House 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 Test Method
Classification of ME Equipment and ME System IEC 60601-1 Clause. 6
ME Equipment Identification Marking and Documents IEC 60601-1 Clause. 7
Protection Against electrical Hazards from ME Equipment IEC 60601-1 Clause. 8
Requirement Related to power Sources IEC 60601-1 Clause. 8.2
Classification of applied Parts IEC 60601-1 Clause. 8.3
Limitation of Voltage Current of Energy IEC 60601-1 Clause. 8.4
Separation of Parts IEC 60601-1 Clause. 8.5
Insulation IEC 60601-1 Clause. 8.8
Creepage Distance and air Clearance IEC 60601-1 Clause. 8.9
Components and Wiring IEC 60601-1 Clause. 8.10
Protection Against Mechanical Hazards of ME Equipment and ME System IEC 60601-1 Clause. 9
Mechanical Hazards of Me Equipment IEC 60601-1 Clause. 9.1
Hazards associated with moving Parts IEC 60601-1 Clause. 9.2
Hazards Associated With Surface Corners and edges IEC 60601-1 Clause. 9.3
Instability Hazards IEC 60601-1 Clause. 9.4
Hazards Associated with Support System IEC 60601-1 Clause. 9.8
Protection Against Excessive Temperature and other Hazards IEC 60601-1 Clause. 11
Excessive Temperature in ME Equipment IEC 60601-1 Clause. 11.1
Fire Prevention IEC 60601-1 Clause. 11.2
Constructional Requirements of Fire Enclosure of ME Equipment IEC 60601-1 Clause. 11.3
Hazardous Situations and fault conditions for ME Equipment IEC 60601-1 Clause. 13
Accuracy of Controls and Instruments and protection against Hazardous IEC 60601-1 Clause. 12
Construction of ME Equipment IEC 60601-1 Clause. 15