Testing services for medical devices and electrical equipment in accordance with MPBetreibV, BetrSichV and DGUV-V3
Ingenieurbüro für Medizintechnik Manfred Krosch
Lothgäßchen 1, 93047 RegensburgNew on Amplifa
About the Engineering Office
Ingenieurbüro für Medizintechnik Manfred Krosch is a sole-proprietor engineering office based in Regensburg offering testing services for medical devices and electrical equipment. It performs metrological checks (MTK) in accordance with § 15 MPBetreibV, safety-related checks (STK) in accordance with § 12 MPBetreibV, and safety-related inspections (STP) in accordance with § 7 MPBetreibV, BetrSichV and DGUV-V3 on the customer's premises. The range of devices covered includes blood pressure monitors, ergometers, defibrillators/AEDs, HF surgical devices, infusion technology, physical therapy devices, ultrasound devices, CTG, ECG, spirometers, and non-medical equipment such as office, kitchen and laboratory devices. The office is located in Regensburg, with a service area covering Upper Palatinate, Lower Bavaria, Upper Bavaria and Middle Franconia. Customers include medical practices, medical care centers (MVZ), clinics and occupational health management across specialties from general medicine to urology. A test report is created for each device, provided with a test sticker, and documented in the medical device logbook.
- Site
- Regensburg
- Processes
- Metrological checks (MTK) in accordance with § 15 and Annex 2 MPBetreibV (blood pressure monitors,, Safety-related checks (STK) in accordance with § 12 and Annex 1 MPBetreibV (defibrillators, AED/PAD,, Safety-related inspections (STP) in accordance with § 7 MPBetreibV, DGUV and BetrSichV (ultrasound,, Safety-related inspections in accordance with DGUV-V3 and BetrSichV for non-medical devices (office,, Safety-related inspection of ultrasound devices (electrical and mechanical safety), Safety-related checks (STK) in accordance with MPBetreibV, Metrological checks (MTK) in accordance with MPBetreibV, Safety-related inspections (STP) in accordance with § 7 MPBetreibV
- Materials
- Metrological Checks (MTK), Safety-Related Checks (STK), Safety-Related Inspections (STP), Testing in accordance with DGUV-V3 / BetrSichV
- Employees
- 1
- Industries
- Healthcare (medical practices, medical care centers, clinics), Occupational health management / company physicians, General medicine, surgery, gastroenterology, Gynecology, cardiology, orthopedics, Pediatrics, physiotherapy, urology, Healthcare: medical practices, medical care centers, clinics, company
- 01
Scheduling coordination with the operator
- 02
On-site testing of devices (MTK/STK/STP)
- 03
Measurement with calibrated testing equipment
- 04
Preparation of the test report for each device
- 05
Marking with test sticker, documentation in the medical device logbook
Testing Equipment and Standards
Metrological Checks (MTK)
In accordance with § 15 and Annex 2 MPBetreibV for blood pressure monitors and ergometers, test interval 24 months.
Safety-Related Checks (STK)
In accordance with § 12 and Annex 1 MPBetreibV for defibrillators, physical therapy devices, HF surgical devices and infusion technology, test interval 12–24 months.
Safety-Related Inspections (STP)
In accordance with § 7 MPBetreibV, DGUV and BetrSichV for all other medical devices, test interval 12–24 months.
Testing in accordance with DGUV-V3 / BetrSichV
Electrical safety for non-medical devices such as office, kitchen, cleaning and laboratory equipment, test interval generally 24 months.
Location
Regensburg
DEOffice/sole proprietorship
- Lode Calibrator 2000 (mobile ergometer test station)
- Senseca/Greisinger GMH (digital fine manometer)
- SPL GM-410 (safety tester)
- SPL DP-600 (defibrillator-pacer-ECG function tester)
- SPL HF-300 (HF power meter)
Types of Devices Tested
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Metrological checks (MTK) in accordance with § 15 and Annex 2 MPBetreibV (blood pressure monitors,Testing | – | – | – | – | – |
| Safety-related checks (STK) in accordance with § 12 and Annex 1 MPBetreibV (defibrillators, AED/PAD,Testing | – | – | – | – | – |
| Safety-related inspections (STP) in accordance with § 7 MPBetreibV, DGUV and BetrSichV (ultrasound,Testing | – | – | – | – | – |
| Safety-related inspections in accordance with DGUV-V3 and BetrSichV for non-medical devices (office,Testing | – | – | – | – | – |
| Safety-related inspection of ultrasound devices (electrical and mechanical safety)Testing | – | – | – | – | – |
5 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Mobile ergometer test station (calibrator) | Lode Calibrator 2000 | – | – | – | Regensburg |
| Digital fine manometer | Senseca (formerly Greisinger) GMH | – | – | – | Regensburg |
| Safety tester | SPL GM-410 | – | – | – | Regensburg |
| Defibrillator-pacer-ECG function tester | SPL DP-600 | – | – | – | Regensburg |
| HF power meter | SPL HF-300 | – | – | – | Regensburg |
Additional services
Qualifications and History
- 1990
Degree in electrical engineering (Dipl.-Ing.(FH)) at FH Regensburg (today OTH Regensburg)
- 2011
Dipl.-Berufspäd. Univ. (electrical engineering and computer science) at TU Munich
- 2015
Master in Health and Medical Management (MHMM) at FAU Erlangen-Nürnberg