Medical Devices Testing
Medical equipments have penetrated in all walks of life where they have replaced the conventional and old designed/bulky devices with the most sophisticated, highly sensitive compact & digital ones. Therefore their safe operation is also a major concern where for such equipments, there is no compromise on Safety and Durability since the devices are operated continuously for hours and days. Hence looking into the requirements in India,CALC has introduced the test facility to conduct Key Safety Test on Medical Devices where recommended tests as per National and International standards have been defined.
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 CALC 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.