Enquiry
Testing Img

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, BTHPL 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 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.

MOU: CSIR-Central   Scientific   Instruments Organisation and BTHPL have formally joined hands for Testing & Calibration of Medical & Bio-medical instruments like Defibrillator, Electrical Safety Test, Electro Surgical Device, ECG, X-Ray Unit, Patient Monitoring System, Ultrasonic-Therapy Unit, Photo-Therapy Unit, Infant Incubator, Pulse Oximeter, NIBP Monitoring System

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)