The medical equipment /instruments used in hospitals for monitoring and treatment of patients also require calibration in order to have confidence in their functioning and operation.
Medical equipment calibration is carried out to minimize the uncertainty in measurements, reducing errors and bringing measurements to an acceptable level. With repeated use and over a period of time, all equipment begins to degrade and that affects its accuracy and precision. In the medical device industry a drift in the measurement is found to be unacceptable. Regularly calibrating equipment will ensure that industry defined standards are met and that equipment is functional thus providing acceptable output.
Key Parameters for testing and calibrating Bio Medical Equipment
| Equipment | Parameter |
|---|---|
| Defibrillator | Electrical Safety Tests |
| Biphasic Energy Management | |
| ECG , Performance and Arrhythmia Simulation | |
| Charge and Discharge Time Test | |
| Waveform Simulation | |
| Pulse Oximeter | Electrical Safety Tests |
| O2 Saturation | |
| Heart Rate | |
| Pulse Amplitude | |
| Selectable Pigmentation and Ambient | |
| Light Condition | |
| Infusion Pump | Electrical Safety Test |
| Flow Rate | |
| Occlusion Alarm Test | |
| Pressure | |
| Patient Simulators | Electrical Safety Test |
| ECG | |
| Blood Pressure | |
| Cardiac Output | |
| Respiration | |
| Temperature | |
| Pacemaker Recognition | |
| Ventilators | Tidal Volume |
| Inspiratory Peak Flow | |
| Inspiratory Peak Pressure | |
| Peep Pressure | |
| Minute Volume | |
| I/E Ratio | |
| Oxygen Level | |
| Inspiratory Hold | |
| Fetal Monitor | Electrical Safety Tests |
| Fetal ECG | |
| Maternal ECG | |
| Uterine Activity | |
| TOCO Simulation |
General requirements for the competence of testing and calibration laboratories.
IEC 60601-1:2005Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
IEC 62353: 2014Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment.
IEC 60601-2-12Medical Electrical equipment Part 2 : Particular requirements for the safety of lung ventilators for medical use.
IEC 60601-2-4Medical electrical equipment Part 2 : Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator monitors.
IEC 60601-2-49Medical electrical equipment Part 2 -49 Particular requirements for the safety of multifunction patient monitoring equipment.
IEC 60601-2-2Medical electrical equipment – Part 2.2: Particular requirements for the safety of high frequency surgical equipment.
IEC 60601-2-24Medical electrical equipment – Part 2 -24 Particular requirements for the safety of infusion pumps and controller.
Lexium has experience in manging calibration programs for some of the reputed medical device manufacturers and Hospitals. We offer both traceable and ISO/IEC 17025 accredited calibrations and can help setup calibration programs or providing audit services to ensure your calibration compliance. Requirements for staying complaint with ISO 13485 and 21 CFR part 820 , CE MDR are written into Lexium Quality manual , giving you peace of mind that your medical /bio medical equipment is being calibrated to the necessary standard . Equipment can be calibrated on site or in one of the partner labs.
Get it touch for your Medical Equipment Calibration Services