Medical Safety Test Lab.
ERTL(South) undertakes Safety Testing of Medical Electrical Equipment/Devices and Medical Electrical Systems as per current International Standards like IEC60601-1.
In addition, we also carry out the following activities :
- Testing of IOT & Wearable medical devices
- Evaluation of Risk Management Documents for Medical Devices as per ISO/IEC 14971.
| Parameter/ Equipment | Make and Model of Equipment |
|---|---|
| Safety Analysers | · Datrend ES601 Plus · Quadtech 6100 Plus (40A Ground bond test) · Metron –QA90 |
| HV Tester | Extech -7021 |
| Regulated AC Power Supply : | High Power EXtech 6400 Series (5KVA) |
| Precision low Voltage Measurement | Agilent 34420 |
| Sound level Measurement | Casella- CEL-24X |
Temperature Measurement:
| · Fluke Black stack 1560 (12 T/C channels) · Fluke 574 |
Patient Vital Simulation:
| Fluke Prosim-8 |
| Defibrillation Simulation | Muller & Sebastiani – Zeus |
ECG Simulation as per IEC60601-2-25
| Muller & Sebastiani – MS410 |
Major Products Tested / Project Done
- ECG machine (Wearable and Diagnostic)
- Digital Video Colonoscope
- Patient Simulators
- Blood Bank Equipment
- Baby Wrap
- Physiotherapy Equipment
- Nebulizer
- Wound Management System
- Oxygen Sensor
- Blood Pressure Monitor
- HDR Brachytherapy System
