High-performance medical technology is used to treat diseases and make diagnoses. Especially in these applications, clear, correct measured values and results are of great importance for each individual patient. Malfunctions of medical devices as a result of untested technology can have serious consequences.
By Dirk Cordt, Marketing Manager International at GOSSEN METRAWATT GmbH.
Worldwide, many international and national regulations exist and are mandatory to ensure the performance, safety and function of medical devices. The test intervals to be observed are often specified by the manufacturer of the medical devices or systems. In any case, the operator of the technical equipment must ensure that the appropriate tests are carried out at appropriate intervals. Technical equipment used directly for medical purposes, such as examinations, treatments or therapies, is used daily in medical practices and medical institutions worldwide. This requires comprehensive electrical and functional testing.
With its brands SECULIFE and RIGEL, GOSSEN METRAWATT, as one of the market leaders in the field of measuring and testing technology, offers two product lines for the professional testing of medical devices in research, production and daily operation.
Safety Technical Control (STC)
The aim of these inspections is to prevent accidents for patients, users and third parties through early detection and, if necessary, the remedying of defects. The risks involved in the event of a malfunction of medical technology are reduced in this way.
Medical devices that must be subjected to a safety inspection include:
– Patient monitors (invasive)
– Ultrasound devices
– HF surgery devices
– Infusion pumps
– Syringe pumps
– External pacemakers
– Ultrasound therapy devices
– ECG devices
The safety check begins with a visual inspection. What is important here is an externally flawless condition. A visual inspection may sound superficial, but it includes a thorough visual examination of many components and parts. Another important part of the safety inspection is the examination of all warning devices and alarms. A responsible inspector is obliged to prepare an inspection report with all the measured values and results of the safety inspection. Only qualified persons are allowed to carry out tests on medical devices and products.
Metrological Control (MC)
In addition to the safety inspection, a metrological inspection is a statutory requirement for medical devices in many cases. Medical technology products with a measuring function that must undergo a metrological inspection include, for example:
– Medical electrical thermometers
– Blood pressure monitors
– Eye tonometers
– Therapeutic dosimeters
– Diagnostic dosimeters
In the case of metrological checks, either comparative measurements are carried out or metrological standards are used as a basis. These standards must only contain small error limits and measurement uncertainties.
Testing of Electrical Safety
Improper use and wear of electrical equipment in medical institutions leads to accidents. Testing of medical equipment is performed before commissioning, after repair, for maintenance or inspection, and in the form of periodic testing. These inspections are designed to ensure the safety of patients, employees and third parties.
– Visual inspection — examination of the electrical equipment for externally visible defects and damage, verification of the existence of safety-relevant labels and proper marking.
– Electrical measurements — recording of various electrical measured variables, depending on the type of device, protection class and measurement procedure.
– Functional test — can only be carried out after a successful visual inspection and fault-free measurement results; the device is tested according to its operating conditions.
After the test has been completed and no defects have been found, the medical device is marked, e.g. with the corresponding test label.