Medical Equipment Calibration Services

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
Patient Simulators Electrical Safety Test
Blood Pressure
Cardiac Output
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

Standards Followed

    ISO/IEC 17025

    General requirements for the competence of testing and calibration laboratories.

    IEC 60601-1:2005

    Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

    IEC 62353: 2014

    Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment.

    IEC 60601-2-12

    Medical Electrical equipment Part 2 : Particular requirements for the safety of lung ventilators for medical use.

    IEC 60601-2-4

    Medical electrical equipment Part 2 : Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator monitors.

    IEC 60601-2-49

    Medical electrical equipment Part 2 -49 Particular requirements for the safety of multifunction patient monitoring equipment.

    IEC 60601-2-2

    Medical electrical equipment – Part 2.2: Particular requirements for the safety of high frequency surgical equipment.

    IEC 60601-2-24

    Medical electrical equipment – Part 2 -24 Particular requirements for the safety of infusion pumps and controller.

Quality Calibration Program Management

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