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Medical Equipment


Medical Equipment

Medical equipment refers to any type of device, instrument, or machine that is used in the diagnosis, treatment, or monitoring of medical conditions. These devices range from simple tools, such as thermometers and stethoscopes, to complex and advanced equipment, such as MRI machines and surgical robots.

Medical Electrical Devices need very delicate evaluation when it comes to compliance testing because they present not only conventional hazards like electrical or mechanical safeguards, but the critical performance of the equipment becomes equally important for patient safety. The user of such equipment is not only the attending professional but also the patient himself. 

Conformity Testing Labs helps to ensure that medical equipment meets the regulatory requirements and industry standards, operates safely and effectively, and provides accurate and reliable results. They help to ensure patient safety, reduce medical errors, and improve the quality of healthcare services.

Some of the common tests for medical equipment are:

  1. Electrical Safety Testing: This test evaluates the electrical safety of the medical equipment, such as insulation resistance, earth continuity, and leakage current tests. This may include evaluation of Safety aspects wrt different kind of radiations like X-Rays, lasers, etc.
  2. Electromagnetic Compatibility Testing: To evaluate the amount of electromagnetic radiations generated or immunity of the equipment to perform in a radiating environment.
  3. Performance Testing: This test evaluates the performance of the medical equipment, such as accuracy of readings, response time, and repeatability.
  4. Functional Testing: This test evaluates the functional operation of the medical equipment, such as the operation of controls and displays, and the ability to perform the intended functions.
  5. Durability Testing: This test evaluates the ability of the medical equipment to withstand repeated use and handling without experiencing significant wear and tear.
  6. Environmental Testing: This test evaluates the ability of the medical equipment to operate in different environmental conditions, such as temperature, humidity, and vibration.
  7. Software Testing: This test evaluates the software components of the medical equipment, such as firmware, operating systems, and application software.
  8. Sterilisation Testing: This test evaluates the ability of the medical equipment to be sterilised using various methods, such as autoclaving, ethylene oxide, and gamma irradiation.
  9. Safety labelling and instruction testing: This test evaluates the safety labels and instructions provided with the medical equipment to ensure that they are clear, concise, and provide adequate information to the user.
  10. Biocompatibility testing: This test evaluates the compatibility of the medical equipment with biological tissues and fluids, and ensures that it does not cause any adverse reactions or harm to the patient.

Testing of electro-medical equipment is generally covered by IS13450 / IEC 60601 are series of technical standards designed to ensure the safety and effectiveness of medical electrical equipment. While Part-1 of the standard lays down generic requirements for any electro-medical equipment, part-2 standards have been published where specific requirements/ deviation apply for a particular products. Collateral standards established as sub part of generic standards are applied for evaluation specific feature as available in the products. Essential performance testing, PEMS and risk assessment form key to medical equipment testing. 

Laboratory Equipments

General Standard

IEC 60601-1:2005 + AMD1:2012 + AMD2:2020

General Requirement Collateral Standards

Such as on Usability, Radiation Protection, Environmentally Conscious Design etc.

Particular Standards

Such as Electron Accelerators, Cardiac Defibrillators etc.

Illustrative Summary of IEC 60601 Standards Family

Testing Facilities with us Include

S. No Products IS/IEC Standards
1. Basic Safety and Essential performance of Medical electrical equipment’s IS 13450(PART1)/ IEC-60601-1
2. Surgical Luminaires And Luminaires For Diagnosis IEC 60601-2-41
3. Operating Tables IEC 60601-2-46
4. Infant Incubators IEC 60601-2-19
5. Infant Transport Incubators IEC 60601-2-20
6. Infant Radiant Warmers IEC 60601-2-21
7. ECG IS 13450 PART 2 SEC 25/ IEC 60601-2-25
8. NIBP IS 13450 PART 2 SEC 30/ ISO 80601-2-30
9. IBP IS 13450 PART 2 SEC 34/ IEC 60601-2-34
10. ECG Monitor IS 13450 PART 2 SEC 27/ IEC 60601-2-27
11. Patient Monitor IS 13450 PART 2 SEC 49/ ISO 80601-2-49
12. Pulse Oximeter IS/ISO 80601-2-61
14. Nebulizer ISO 27427
15. Thermometer IS/ISO 80601-2-56
16. Operating Table IEC 60601-2-46
17. Surgical Luminaire IEC 60601-2-41
18. Radiant Warmer IEC 60601-2-21
19. Infant Incubator IEC 60601-2-19
20. Transport Warmer IEC 60601-2-20
21. In-Vitro Diagnostic Material IEC 61010-1
22. Irradiance Meter IEC 61010-1
23. Glucometer IEC 61010-2-101
25. Me Equipment For Home Healthcare Environment IEC 60601-1-11
26. Me Equipment For Emergency Services IEC 60601-1-12
27. Risk Management for Medical Devices ISO 14971
28. Programmable Electrical Medical Systems (PEMS) IEC 62304

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WH-52, Mayapuri Industrial Area Phase-I, New Delhi-110064

+91-9999101371, 011-42154411,
011-28114400/ 28114411/ 28114422

A-33, Mayapuri Industrial Area Phase-I, New Delhi-110064

+91-9999101371, 011-28116600,


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