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 Colposcope
- Patient Simulators
- Blood Bank Equipment
- Baby Wrap
- Physiotherapy Equipment
- Nebulizer
- Wound Management System
- Oxygen Sensor
- Blood Pressure Monitor
- HDR Brachytherapy System
