A large number of in some cases very complex technical medical devices are used in today’s healthcare facilities. People’s lives often depend on these. This is why it is eminently important that you can rely on the proper and safe operation of the equipment used.
Legislature has created an obligation for regular checks with the Medical Devices Act and the Medical Devices Operator Ordinance; this may vary between 12 and 36 months depending on the type of device. During this so-called “technical safety test”, technical medical devices in Austria have to be regularly tested with respect to their safety and perfect functioning so as to protect patients.
This test determines the safe and technically reliable condition of the medical equipment.
Your advantages from a cooperation with TÜV AUSTRIA Medical Technology:
- Profit from our decades of experience in the field of medical engineering, the great expertise of our staff and our cooperation in norms and standards
- We are objective, do not have a close or dependent relationship with industry, commerce or authorities and are free from any instructions in our assessments
- Thanks to our many years of experience in the healthcare sector, we are familiar with the procedures and can thus perform the tests quickly and smoothly on your premises
- Save time and costs by having a number of different equipment groups tested by one company – your one-stop solution!
- Our internationally recognized tests and test certificates are based on quality-assured checklists. This is your guarantee for legal security, and saves time and effort
- The measuring and test equipment we use is modern, calibrated regularly and replaced by the latest equipment on a regular basis
- Our nationwide network of service points in Austria helps save your travelling costs.
- In accordance with the Medical Devices Operator Ordinance, the technical safety tests may only be carried out by suitable persons and agencies
- TÜV AUSTRIA Medical Technology is an accredited inspection body for medical products and thus demonstrably authorized for this work
Operators of healthcare facilities such as
- Rehabilitation centers
- Nursing homes
- Medical practices
- Outpatient clinics
- Physical therapy institutes
- X-ray, MR, CT institutes
- We will be pleased to prepare a quotation for the services you desire. Following your confirmation of the order, one of our test engineers will contact you to arrange an individual appointment.
- Our test engineers test your technical medical equipment on your premises, with due regard for your day-to-day procedures.
- The scope of the test depends on the statutory requirements and the manufacturer’s instructions. The equipment is tested in terms of its electrical safety as well as its proper functioning, e.g. alarms, output ratings, parameter displays, etc.
- Depending on the scope of testing, you will be informed of the results either regularly or on completion of the tests – this can be agreed upon as required with the test engineer.
- We mark the tested devices and systems with a test sticker that clearly shows the date of the next test.
- The documentation is supplied in a format of your choice: paper report, PDF and in a digital form as a data import file for your FM software.
- We can also help with suggestions on how to remedy any faults or failings that may be discovered.
- Medical Devices Act, MPG
- Medical Devices Operator Ordinance, MPBV
- ÖVE EN 62353
- Parts of ÖVE EN 60601
- Guidelines for safety and metrological inspections of medical devices of the National Metrology Institute (PTB)
- Syringe infusion pumps
- Stimulation current devices
- High-frequency surgical equipment
- Patient monitors
- Electric medical beds
- Respiratory devices
- X-ray systems
- Ultrasound units