Solution: Ongoing technical safety testing of medical devices (oTST/STK)

Solution: Ongoing technical safety testing of medical devices (oTST/STK)

Medizintechnik / Krankenhaustechnik - TÜV AUSTRIA Group

Deutschstraße 10 1230 Wien Österreich

+43 5 0454 6501

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TÜV AUSTRIA GMBH

Region: Österreich

Deutschstraße 10 1230 Wien Österreich

+43 5 0454 0

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Target group

Operators of health care facilities

  • Hospitals
  • Rehabilitation centres
  • Nursing homes
  • Medical practices
  • Outpatient clinics
  • Health spas
  • Physical institutes
  • X-ray, MR, CT institutes
  • etc.

Legal & normative bases

  • Medical Devices Act, MPG
  • Medical Device Operator Ordinance, MPBV
  • ÖVE EN 62353
  • Parts of the ÖVE EN 60601
  • Guideline on metrological controls of medical devices of the Physikalisch-Technische Bundesanstalt, Germany

Procedure of the examination

  • We will be happy to provide you with a quotation for the services you require. After your order confirmation, a test technician will contact you to arrange an individual appointment.

  • Determination the testing scope based on the legal and manufacturer requirements.

  • Our test technicians check your medical-technical devices and systems on site, taking into account the daily processes.

  • The devices are checked for electrical safety and proper functioning of e.g. warning devices, output power, parameter displays, etc.

  • Depending on the scope, you will be informed about the results on a regular basis or after completion of the tests – you can arrange this with the test technicians if you wish.

  • We mark the inspected devices and systems with an inspection sticker on which you can quickly and clearly see the date of the next inspection.

  • The documentation is delivered in a format of your choice: Paper report, PDF and in digital form as a data import file for your FM software.

  • We support you with proposed solutions to remedy any deficiencies that are identified.

  • optional: Testing through medical software compliance check by our co-operation partner x-tention according MDR (Medical Device Regulation)

"Ongoing technical safety testing of medical devices: experience in health sector, accredited, authorised inspection body for medical devices."

Technical medical devices have become indispensable in
health facilities, where complex devices can make the difference between life and death and the well-being of patients.
Device safety, that is, proper function in accordance with
the application, is thus extremely important.

Legislation in the form of medicinal product laws (e.g., the
Medical Device Law) mandates health facilities to carry
out regular inspections at intervals of 6 to 36 months,
depending on the type of device.

The safety and the flawless function of technical medical
devices must be tested and ascertained in the form of
“technical safety inspections” on a regular basis for the
protection of patients.

Examples of devices

  • Syringe Infusion Pumps
  • Electrosurgical Units
  • Electric Hospital Beds
  • Defibrillators
  • Ventilators
  • Radiographic Units
  • Ultrasound Units
  • ECG
  • Pacemakers
  • and much more

Your advantages

  • Benefit from our decades of experience in the field of medical technology, the high level of expertise of our staff and our collaboration on norms and standards.
  • We are objective, have no close or dependent relationship with industry, trade or authorities and are not bound by instructions in our assessment.
  • Thanks to our many years of experience in the health sector, we know the procedures and can therefore carry out the inspections at your premises as quickly and trouble-free as possible.
  • Save time and money by having many different groups of equipment inspected by one company – all from one source!
  • Our internationally recognised tests and test reports are based on quality-assured checklists. This gives you legal certainty and saves you time and effort.
  • The measuring and testing equipment we use is modern, regularly calibrated and replaced with the latest equipment.
  • The nationwide distribution of our offices in Austria helps you to save travel costs.
  • According to the Medical Device Operator Ordinance, safety inspections may only be carried out by suitable persons and bodies. TÜV AUSTRIA Medizintechnik is an accredited inspection body for medical devices and thus demonstrably authorised to do so.

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