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.
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.
IEC 60601-1:2005 + AMD1:2012 + AMD2:2020
Such as on Usability, Radiation Protection, Environmentally Conscious Design etc.
Such as Electron Accelerators, Cardiac Defibrillators etc.
Illustrative Summary of IEC 60601 Standards Family
|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|
|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|
|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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