MEDTEQ Testing Services
The MEDTEQ facility has a medium range of test equipment as detailed below for testing to various standards. MEDTEQ reports have the equivalent status of a manufacturer's report, which is acceptable under medical device regulations for many regions, such as US, Europe, Canada and Australia. The reports contain a cover page, general description, sample identification (including photos), clause list (core evaluation), and test data. Unlike CB scheme reports, the test data section is a self contained record for all items inspected, measured or tested, with full details such as test engineer, sample identification, testing dates, environment, test equipment and methods used. This detail provides confidence for regulatory auditors.
Testing may be useful for investigation before working with the bigger agencies, and also for specialized subjects like ECG, NIBP, IBP, HF surgery where the agencies may have limited experience. Past private clients (MEDTEQ reports) include ECG performance tests (IEC 60601-2-25, IEC 60601-2-27), ECG database testing (IEC 60601-2-47)/AAMI EC 57), HF surgical active electrodes (IEC 60601-2-2), clinical thermometers (ISO 80601-2-56), pre-submission testing and small battery operated for IEC 60601-1, Subcontract work for agencies includes ISO 8185 tests for humidifiers, and IBP sensors (JIS T 3323, based on AAMI BP 22).
Equipment list includes (not limited to):
- 2kVA AC/DC power supply (0-300Vac, 1-999.9Hz or DC)
- 10kV/100mA voltage withstand tester
- 6.5 digit precision multimeters (JQA calibrated)
- Pt100 probes and meters, 0.001°C resolution/0.02°C calibration (JQA)
- MEDTEQ HBTS, 8 channel temperature logger with 0.01°C resolution/0.1C calibration
- Thermocouples/temperarture loggers
- Sound level meters
- PC oscilloscopes, 12 bit resolution, 100:1, 1000:1 active differential probes
- Digital function generators, DC power supplies
- Light meter (calibrated)
- LCR meter (calibrated at 47nF, 4.7nF for ECG work)
- 0-6000g scales, 0.1g resolution (JQA calibrated)
- Digital calipers (JQA calibrated)
- Small peltier chamber control to 0.05°C stability (useful for temperature sensitive parts like IBP sensors)
- 1m² environmental chamber (temp/RH control by PC)
- Thermal imaging camera
- various 0.05% pressure gauges, 0-700mmHg range (JQA calibrated)
- absolute pressure gauge
- flow source, air flow gauge, air drying (for ISO 8185 humidifier testing)
- MEDTEQ equipment range: HFIT, IBPS, PPS, HBTS, SRJ and Whaleteq SECG, MECG, CMRR
For services, customers can contact Peter Selvey for a quote. Prices are reasonable and for small amounts, convenient payment available, including using the Testing/Consultation fee blocks available on this website.