Electrical Safety Testing
Medical Electrical Devices and Equipment have to comply to the IEC 60601-1 for General Safety and IEC 60601-1-2 for EMC. IEC 60601-1 (General requirements for safety), IEC 60601-1-xx (Collateral) and IEC / ISO 60601-2-xx / 80601-2-xx (Particular) series of standards.
In General Safety Testing as per IEC 60601-1 following are the key test parameters:
- Earth-bond Testing
- Leakage Measurement including
- Earth Leakage
- Enclosure Leakage
- Applied Part or Patient Leakage: Normal Condition
- Patient Leakage : Single Fault Condition, Supply Open
- Patient Leakage: Single Fault Condition, Earth Open
- Patient Leakage F-Type
- Patient Auxiliary Current: Single Fault, Supply Open
- Patient Auxiliary Current: Single Fault, Earth Open and more...
EMI / EMC Testing: We offer testing services for EMC as per IEC 60601-1-2 namely
- Electrostatic discharge (ESD) immunity test
- Electrical fast transient (EFT) immunity test
- High Energy Surge immunity test
- Damped Oscillatory waves immunity test
- Voltage Dips and Interruptions
Product Specific Standards:
| IEC 60601-1-1 | Medical electrical equipment - Part 1: General requirements for safety 1: collateral standard: safety requirements for medical electrical systems |
| IEC 60601-1-2 | Medical electrical equipment - Part 1: General requirements for safety 2. Collateral standard: electromagnetic disturbances - requirements and tests |
| IEC 60601-1-3 | Medical electrical equipment - Part 1: General requirements for safety and essential performance - collateral standard: radiation protection in diagnostic x-ray equipment |
| EN 60601-1-4 | Medical electrical equipment - Part 1-4: General requirements for collateral standard: programmable electrical medical systems |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for safety and essential performance - collateral standard: usability |
| IEC 60601-1-8 | Medical electrical equipment - Part 1-8: General requirements for safety and essential performance- collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| IEC 60601-1-11 | Medical electrical equipment - Part 1-11: General requirements for safety and essential performance- collateral standard: requirements for medical electrical equipment used in the home healthcare environment |
| IEC 60601-2-1 EN 60601-2-1 |
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| IEC 60601-2-2 EN 60601-2-2 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| IEC 60601-2-3 EN 60601-2-3 |
Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment |
| IEC 60601-2-4 EN 60601-2-4 |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| IEC 60601-2-5 EN 60601-2-5 |
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
| IEC 60601-2-6 EN 60601-2-6 |
Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
| IEC 60601-2-7 EN 60601-2-7 |
Medical electrical equipment - part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic x-ray generators |
| IEC 60601-2-8 EN 60601-2-8 |
Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
| IEC 60601-2-9 EN 60601-2-9 |
Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors |
| IEC 60601-2-10 EN 60601-2-10 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle simulators |
| IEC 60601-2-11 EN 60601-2-11 |
Medical electrical equipment. Part 2-11. Particular requirements for basic safety and essential performance of gamma beam therapy equipment |
| ISO/IEC 80601-2-12 EN ISO 80601-2-12 |
Medical electrical equipment. Part 2-12. Particular requirements for basic safety and essential performance of critical care ventilators |
| ISO/IEC 80601-2-13 EN 60601-2-13 |
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| IEC 60601-2-14 EN 60601-2-14 |
Medical electrical equipment - Part 2: Particular requirements for the safety of electroconvulsive therapy equipment |
| IEC 60601-2-15 | Medical electrical equipment - Part 2: Particular requirements for the safety of capacitor discharge x-ray generators |
| IEC 60601-2-16 EN 60601-2-16 |
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| IEC 60601-2-17 EN 60601-2-17 |
Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically driven gamma-ray after-loading equipment |
| IEC 60601-2-18 EN 60601-2-18 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| IEC 60601-2-19 EN 60601-2-19 |
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| IEC 60601-2-20 EN 60601-2-20 |
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| IEC 60601-2-21 EN 60601-2-21 |
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
| IEC 60601-2-22 EN 60601-2-22 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60601-2-23 EN 60601-2-23 |
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
| IEC 60601-2-24 EN 60601-2-24 |
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| IEC 60601-2-25 EN 60601-2-25 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| IEC 60601-2-26 EN 60601-2-26 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| IEC 60601-2-27 EN 60601-2-27 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| IEC 60601-2-28 EN 60601-2-28 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| IEC 60601-2-29 EN 60601-2-29 |
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
| IEC 80601-2-30 EN 60601-2-30 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| IEC 60601-2-31 EN 60601-2-31 |
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
| IEC 60601-2-32 EN 60601-2-32 |
Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of x-ray equipment |
| IEC 60601-2-33 EN 60601-2-33 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| IEC 60601-2-34 EN 60601-2-34 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| IEC 80601-2-35 EN 80601-2-35 |
Medical electrical equipment. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| IEC 60601-2-36 EN 60601-2-36 |
Medical electrical equipment. Particular requirements for the basic safety and essential performance of extracorporeally induced lithotripsy |
| IEC 60601-2-37 EN 60601-2-37 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| IEC 60601-2-38 EN 60601-2-38 |
Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds |
| IEC 60601-2-39 EN 60601-2-39 |
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
| IEC 60601-2-40 EN 60601-2-40 |
Medical electrical equipment - Part 2-40: Particular requirements for the safety of eletromyographs and evoked response equipment |
| IEC 60601-2-41 EN 60601-2-41 |
Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
| IEC 60601-2-43 EN 60601-2-43 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
| IEC 60601-2-44 EN 60601-2-44 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
| IEC 60601-2-45 EN 60601-2-45 |
Medical electrical equipment - Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices |
| IEC 60601-2-46 EN 60601-2-46 |
Medical electrical equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating tables |
| IEC 60601-2-47 EN 60601-2-47 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| IEC 60601-2-49 EN 60601-2-49 |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| IEC 60601-2-50 EN 60601-2-50 |
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
| IEC 60601-2-51 EN 60601-2-51 |
Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| IEC 60601-2-52 EN 60601-2-52 |
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds |
| IEC 60601-2-54 EN 60601-2-54 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
