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NEWBTHPL has state-of-the-art test facility for LED Lightings with C-Type Goniophotometer NEWEMI/EMC Test facility approved by FCC/IC.NEW BTHPL empanelled by BEE for Check Testing of Energy Rated productsNEW EESL empanelled BTHPL to test LED Lamps & Street Lights under DELP programNEW BTHPL can now test Batteries, CE Marks & Telecom Products.

Medical Devices Testing

Electrical safety testing in general is essential to ensure safe operating standards for any product that uses electrical power. Various governments and 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 product to conform to safety standards implemented by Safety & Standard agencies. To conform to such standards, the product must pass safety tests like High Voltage Test, Insulation Resistance Test, Leakage Current Test, Earth Leakage Current Test, Enclosure Leakage Current Test etc. These tests are described in ISO/IEC and many other National and International standards.

Medical equipments have penetrated in all walks of life where they have replaced the conventional and old designed / bulky devices with the most sophisticated, compact & digital ones. Therefore their safety 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, BTHPL has recently introduced the test facility to conduct key Safety test on Medical devices where recommended tests as per National and International standards have been defined.

The current scope of Safety Testing in BTHPL 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.

S.No.
Test Parameter - IS:13450 & IEC 60601: 2005 Test Clause
01
Power input
IEC 60601(Cl.4.11)
02
Marking and Instruction
IEC 60601(Cl.7)
03
Determination of accessible parts
IEC 60601(Cl.5.9)
04
Protective earthing, Functional earthing, Potential equalization, Surface Coating, Plugs & Sockets, Functional Earth Terminal
IEC 60601(Cl.8.6)
05
Leakage Currents and Patients auxiliary currents
IEC 60601(Cl.8.7)
06
Dielectric Strength
IEC 60601(Cl.8.8)
07
Resistance to environmental stress
IEC60601:Cl.8.8.4.2
08
Accessible Parts Including Applied Part
IEC 60601(Cl.5.9)
09
Creepage distances and Air clearance
IEC 60601(Cl.8.9)
10
Overflow,Spillage,Leakage ingress of water/ Particulate matter,Cleaning,Disinfection,Sterilization & Compatibility with Substances used with ME eqpt
IEC 60601(Cl.11.6)

 

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