Service Provider , Professional Services, Brand Owner · Sonipat, Haryana, India
Bharat Test House Pvt. Ltd. (BTH) is a trusted and time-tested independent testing, inspection and certification organization serving leading manufacturers, exporters, importers, government and non-government institutions across India and international markets. With strong technical expertise and accredited facilities, BTH provides reliable, accurate and prompt services in the areas of testing, inspection, certification, calibration and consultancy for a wide range of industrial products and materials.
BTH is committed to supporting quality, safety and global compliance by helping industries meet National and International Standards. The organization continuously works towards educating and motivating manufacturers, suppliers and users for procurement and supply of quality products conforming to regulatory and customer-specific requirements. With a customer-focused approach, technical competence and commitment to integrity, BTH has emerged as a dependable partner for industries seeking trusted quality assurance and export compliance solutions.
Registered address: Sonipat, India.
Industry: Business Services & Consultancy > Process & Certification.
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
Product Description
S. No.
Testing Product Category
Related Standard
1
Testing of Medical Electrical Equipment: Surgical Luminaries & Luminaries for Diagnosis, Operating Tables Etc
IEC 60601-1, IS 13450-1, IEC 60601-2-41, IEC 60601-2-46
2
Testing of Medical Electrical Equipment: Baby Incubator & Ultrasonic Physiotherapy Equipment
IS 13450-2-19/IEC 60601-2-19, IS 13450-2-5/IEC 60601-2-5, IS 13450-2-49/IEC 60601-2-49, IS 13450-2-4/IEC 60601-2-4, IS 13450-2-21/IEC 60601-2-21
Description provided by BHARAT TEST HOUSE PRIVATE LIMITED.
Specifications
Product Name
Medical Devices Testing
Store Name
BHARAT TEST HOUSE PRIVATE LIMITED
Product Category
healthcare > medical tests
Product Type
Service
MOQ
1
Test Type
Electrical safety testing for medical devices
Standards
IEC 60601-1, IS 13450-1, IEC 60601-2-41, IEC 60601-2-46, IS 13450-2-19 / IEC 60601-2-19, IS 13450-2-5 / IEC 60601-2-5, IS 13450-2-49 / IEC 60601-2-49, IS 13450-2-4 / IEC 60601-2-4, IS 13450-2-21 / IEC 60601-2-21
Devices Covered
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
Additional Tested Products
Surgical Luminaries, Luminaries for Diagnosis, Operating Tables
Test Parameters
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, Cleaning, Disinfection, Sterilization, Compatibility with Substances used with ME Equipments
Partnership / MOU
CSIR-Central Scientific Instruments Organisation and BTHPL
Market Segment
B2B medical device compliance and testing
Use cases
Category
Medical Device Electrical Safety Testing
Primary application
Wholesale, distribution, and international sourcing
Brand
Not specified
Product type
Service
Logistics & handling
Lead time
On request
Packaging
As per buyer requirement
Storage condition
As recommended by supplier
Origin
India
Form
As listed by supplier
Commercials (this seller)
Minimum order
1 unit
Lead time
On request
Payment terms
As per negotiated commercial agreement.
Checkout type
enquiry
Buyer questions
Frequently asked by buyers
Common questions B2B buyers ask before sourcing Medical Device Testing Laboratory Services for Regulatory Compliance. Answers compiled from verified sellers' commercial terms and platform data.
Q: Which medical devices are covered under this testing service?
A: The listed standards include IEC 60601-1, IS 13450-1, IEC 60601-2-41, IEC 60601-2-46, IS 13450-2-19 / IEC 60601-2-19, IS 13450-2-5 / IEC 60601-2-5, IS 13450-2-49 / IEC 60601-2-49, IS 13450-2-4 / IEC 60601-2-4, and IS 13450-2-21 / IEC 60601-2-21.
Q: What electrical safety parameters are tested?
A: The scope includes input power, accessible parts, protective earthing, functional earthing, leakage current, patient auxiliary current, plugs and sockets, dielectric strength, creepage distances, air clearance, and functional earth terminals.
Q: Does the service cover cleaning and sterilization compatibility?
A: Yes, the scope explicitly includes cleaning, disinfection, sterilization, and compatibility with substances used with medical electrical equipment.
Q: Is this testing suitable for OEM and export compliance?
A: Yes, it is suitable for OEM qualification, regulatory compliance, and export-ready documentation for electrically powered medical devices.
Q: What is the minimum order quantity for this service?
A: The minimum order quantity is 1, which allows a single device, model, or compliance test assignment to be booked.
Q: Who is the service provider?
A: The service is offered by BHARAT TEST HOUSE PRIVATE LIMITED, with a formal testing and calibration association involving CSIR-Central Scientific Instruments Organisation.
Question not answered? Ask sellers directly — typical response within 4 hours.
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