Medical Device Standards and Regulations Quiz

What is a floating input of a medical device?. An input with a ground connection separated from the rest of the device by an optocoupler and galvanic isolation. An input with galvanic isolation from the rest of the device. An input with galvanic isolation and signal transmission to another part of the device, e.g., via an optocoupler.

What is the Wilson's ground connection?. A special terminal for attaching the ground electrode to the patient's left leg during ECG recording. A special terminal for attaching the ground electrode to the patient's right leg during ECG recording. A reference point with the average potential of R, L, and F.

What does the input part of a CF type device guarantee?. Reduced leakage currents to the patient and increased safety. Reduced interference from the mains network. Good connection of the patient to the main part of the medical device, thus reducing interference from the mains network.

What is a neutral electrode in differential amplifiers?. An electrode that does not polarize. An electrode used as a common terminal for differential amplifiers and/or for noise suppression. An electrode that is difficult to polarize and has either a positive or negative voltage.

What is the input impedance of an electromyograph?. 100 kΩ. 100 MΩ. 1000 Ω.

According to the standard, if a muscle stimulator must be type BF or CF, what does this imply?. The auxiliary electrode must be well-connected to the leg (CF – Conner with foot?). The output of the stimulator must be floating. The output of the stimulator must be connected to the rest of the device with minimal transition resistance.

When a standard states that stimulation tips (electrodes) can be bipolar, what does this mean?. They can transmit impulses of both polarities emitted by the pacemaker. They are two independent tips (electrodes). They are two tips, one of which is connected to the pacemaker's ground electrode.

What does 'inhibition' mean for a demand pacemaker?. The pacemaker sends stimulation impulses after evaluating the P-P interval. Upon detection of a pre-selected signal, the corresponding pacemaker function is blocked. The pacemaker sends data about its settings to an external monitoring device upon an external stimulus.

What is a condition for successful steam sterilization?. Steam supplied at sufficient pressure. Perfect aeration of the sterilization chamber (vacuum around 70kPa) followed by steam filling. Sufficient quantity of items in the sterilization chamber to avoid air pockets, with items properly arranged.

What is a CO-oximeter?. An optical blood analyzer with multiple wavelengths that measures total Hb concentration and various Hb derivatives. A comparative pulse oximeter used for calibrating a working device. An optical device for determining blood oxygen levels in cases of CO poisoning.

What is used for basic calibration of a pulse oximeter?. Calibration curves derived from the Lambert-Beer law. Calibration curves derived from the Pimonov integral. Empirically determined calibration curves.

What are the most important components of a lithotripter?. A shock wave generator and an adjustable patient table. A timer for the shock wave generator and a safety switch. A shock wave generator and a targeting system.

How is temperature measured in a neonatal incubator?. In all corners of the incubator; it must not drop below the set limit anywhere. The air temperature is measured 10 cm above the mattress surface in the neonatal space. The temperature is measured at the level of the ports used for manipulating the neonate (in a closed incubator).

For non-invasive blood pressure monitors with cycling, what must happen in case of a power failure?. The medical staff must be alerted by an alarm signal to reduce cuff pressure on the patient's arm. The cuff must be deflated within 30 seconds to below 15 mmHg for adults or 5 mmHg for neonates, and any blood pressure indication must be canceled. The cuff must be deflated within 30 seconds to below 15 mmHg for adults or 5 mmHg for neonates, and any blood pressure indication must be stored in the device's memory.

What is the purpose of the chamber in some blood pressure monitors?. To store a spare sterile catheter for immediate use in case of problems. A hydraulic link between the patient's blood pressure and the transducer, if an external transducer is used. A reservoir of physiological saline from which the catheter is filled if the pressure transducer is located outside the patient.

What is the Trendelenburg position?. An electrically controlled counterweight holder for patients with leg fractures. An electrically height-adjustable holder for infusion solutions during gravity infusion. Tilting the entire mattress support so that the patient's head is lower than the center of the body's circulatory system.

What defines a volumetric infusion pump?. An infusion pump where the dosage rate is set by the operator and indicated by the device as volume per unit of time, and which is not a syringe pump. An infusion pump where the dosage rate is set by the operator setting the drop size of the infusion solution in a measuring chamber. An infusion pump that sums the total volume of delivered infusion solution.

What is an ionization chamber?. A detector of ionizing radiation that uses the conduction of electric current in a vacuum. A detector of ionizing radiation composed of a chamber filled with air, where the electric field is insufficient to multiply gas ions. A detector of ionizing radiation composed of a chamber filled with air, where the electric field is sufficient to multiply gas ions.

What causes tissue damage from radioactive radiation?. Only the part of the radiation energy absorbed by the tissue can cause damage. Only the part of the radiation energy reflected by the tissue can cause damage. Only the part of the radiation energy that sufficiently heats the tissue can cause damage.

What is an automatic defibrillator used for?. Atrial flutter. Ventricular fibrillation. Atrial fibrillation.

Which test can unambiguously prove the effectiveness of sterilization?. Physical test. Chemical test. Microbiological test.

What type of sterilization is used for new surgical instruments?. Chemical sterilization. Sterilization by radiation. Dry heat sterilization.

What is the minimum infusion pump flow rate defined by the standard?. Min. 100 ml/hour. Min. 1 ml/hour. Min. 1 µl/hour.

What is a Class CF applied part?. A fixed part of the device connected by a flexible conductor. A floating part of the device that ensures higher patient safety. An external peripheral device not subject to the standard's specifications.

What is the input impedance of an electromyograph?. 100 Ω. 100 kΩ. 100 MΩ.

What is considered a false positive alarm state?. No monitored values deviated beyond the allowed limits, but an alarm was triggered. Monitored values deviated beyond the allowed limits, but no alarm was triggered. Monitored values deviated beyond the allowed limits, the alarm was triggered, but automatically reset and turned off.

What environmental parameters are monitored during 'normal conditions' tests?. Temperature 25°C and relative humidity 75%. Temperature 23 ± 2°C, relative humidity 60 ± 15%, and atmospheric pressure 860 to 1060 hPa. Temperature 35 ± 10°C, relative humidity 60 ± 30%, and atmospheric pressure 862 to 1060 hPa.

What does the term 'radiation weighting factor' refer to?. It accounts for the different biological effectiveness of various types of ionizing radiation. It is no longer used and has been replaced by 'exposure rate'. It defines the patient's subjective perception of ionizing radiation therapy.

What does a standard specifying general requirements for devices call itself?. Particular. Group. Basic.

In the process of risk management, alternative solutions cannot be used in which case?. When the residual risk of the alternative solution is higher than the residual risk of the standard. When the residual risk of the alternative solution is the same as the residual risk of the standard. When the residual risk of the alternative solution is lower than the residual risk of the standard.

To prevent patient harm from unwanted heating during dialysis, the solution should be: Colder than 41°C. Exactly 41°C. Warmer than 41°C.

Where should exhaust vents for medical gases from a room be located?. Must have a shut-off valve in the path. Must discharge into a collection reservoir. Must be located away from building windows.

To protect against mechanical hazards, what must the manufacturer ensure regarding the gap between parts of a medical bed?. It must be either larger than 25 mm or smaller than 8 mm. It must be within the interval of 15 mm to 25 mm. It must be less than 10% of the largest dimension of the bed.

What type of current can cause ion buildup on the patient's skin when passing through it?. Direct current (DC). Alternating current (AC). Biphasic.

In which situation are the requirements of the basic medical standard NOT applicable?. When a cleaner, Maria, slips while cleaning the cover of a linear accelerator. When patient Luboš dies after his pacemaker unexpectedly runs out of battery. When patient Rudolf is bitten on the leg by a dog hanging from the operating table.

What does the 'prohibition' sign look like?. A yellow triangle with a black exclamation mark inside. A red circle with a diagonal line through it. A blue circle with a white exclamation mark inside.

What dampens ultrasonic waves the most?. Water. Air. Tissue.

What type of dialysis involves introducing dialysis fluid into the abdominal cavity?. Bicarbonate. Acetate. Peritoneal.

Which standard has the highest priority in the hierarchy of norms?. Basic. General. Particular. Group.

The standard for sphygmomanometers specifies protection against water and solid objects. For devices used during patient transport outside healthcare facilities, what does IPX2 protection mean?. Protection against spraying water. Protection against heavy spraying water. Protection against dripping water at a 15% angle. Protection against immersion during temporary submersion.

The initiation of shock wave generation in lithotripters must be synchronized with a biosignal. Which biosignal is it?. EKG. EEG. EMG. EGG.

For an anesthetic vaporizer (anesthetic gas container), the operator must be able to understand which position of the control element closes the vaporizer outlet. The standard indicates three ways to indicate this position. Which one is NOT used?. Preparation/Standby. Out of service. 0. Off.

Microbiological testing of sterilization effectiveness requires the use of: 1 working and 1 reference sample. 5 working and 5 reference samples. 8 samples (in the corners of the sterilization chamber) and 2 reference samples. 9 working samples and 1 reference sample.

The normal sensitivity of an ECG device on the recording trace represents a deflection of: 25 mm/mV. 100 mm/mV. 10 mm/mV. 10 mm/V.

The DDI mode represents a pacemaker that: Paces in the atrial channel and inhibits in the ventricular channel. Has sequential stimulation with ventricular inhibition. Has inhibition in both channels. Is triggered by the atrium and paces the atrium.

Regarding the legibility of device markings, for which group of observers must the marking NOT necessarily be clearly visible from the operating position?. For warnings, instructions, safety signs, and diagrams. For fixed devices in their normal position. For service personnel. For portable devices in their normal position, when moved away from the wall and rotated.

For successful sterilization, the probability of non-sterile items is considered maximally: 1:10. 1:1,000,000. 1:10^9. 1:10,000.

What is the approximate current used in electrotherapy for stimulation?. 10 mA. 1 kA. 10 A. 10 pA.

A correction factor for dosimeters is: A constant used to correct the measured value under certain conditions to a value corresponding to the given reference conditions. A factor that accounts for background radioactivity at the measurement site. A factor that distinguishes the type of ionizing radiation being measured. A factor used to correct for the different sensitivities of the user's organism.

According to the standard, the maximum pressure in the normal mode of a sphygmomanometer must not exceed: 500 mmHg. 700 mmHg. 1000 mmHg. 300 mmHg.

Dialysis machines are equipped with audible and visual alarms. Which type of alarm can be muted?. Visual. Audible. Both. Neither.

The standard time base for an EEG recording trace is: 3 cm/s. 1 cm/s. 15 mm/s. 50 mm/s.

Which standard has the lowest priority (least important) in the hierarchy of norms?. Group. Basic. Particular. Traction.

The surface temperature of an ultrasonic therapy head must not exceed: 36.6 °C. 45 °C. 37 °C. 41 °C.

What change in blood pressure in the hemodialysis system can be used to detect a blockage caused by a blood clot?. Between the dialysis capsule and the return needle. Between the suction needle and the peristaltic pump. Between the peristaltic pump and the dialysis capsule. In the return needle.

What is the average consumption of dialysis fluid (corresponding to average primary daily urine output) during dialysis?. 1-2 liters. 1000-2000 liters. 10-20 liters. 100-200 liters.

What constitutes 'auxiliary current' to the patient?. Not an exceptional state up to a maximum of 100 mA. A fault state that the device must react to with a signal. Not an exceptional state, e.g., leakage current from a switch. A fault state that the device must react to by disconnecting from the mains.

How is the elimination of faults in the infusion pump control system ensured?. By a set of two independent control microprocessors. By a recursive program for the dosing mode. By a set of three independent control microprocessors. By programming in machine code (assembler).

Radiation sterilization can be used to sterilize exclusively: Instruments made of surgical steel. Instruments made of composite materials. New, previously unused instruments. Any instruments.

During marking durability tests, the marking is rubbed with a cloth soaked in liquid. Which liquid is NOT used for this purpose?. Denatured alcohol. Body fluid (urine, blood). Isopropyl alcohol. Distilled water.

The function of devices for determining blood oxygen saturation is verified using testers. Which principle is NOT used for these purposes?. Tester using a colored mixture. Tester using a modulator with liquid crystals. Tester using calibrated red paper strips. Tester using a photodiode and LED for interaction with the pulse oximeter probe.

Protection of a medical bed against electrical hazards is NOT achieved by: Protecting cables from abrasion or rubbing against sharp edges. Mechanical resistance of supply lines, cables, and cords. A mains supply cord longer than 2.5 m. An additional detachable grounding cable connected to the bed frame.

Which material is best for constructing medical gas pipeline systems to resist corrosion and be compatible with the gases?. Zinc. Aluminum. Surgical steel. Copper.

Gas cylinders must be connected using a flexible connection according to ISO 219669. What material is permitted by the standard for this flexible connection?. Silicone. PVC. Rubber. Metal.

The process of killing or removing microorganisms from an environment or object, regardless of the reduction in their count, is called: Sterilization. Pasteurization. Decontamination. Disinfection.

During nocturnal peritoneal dialysis, a cycler machine is used. Its function is to periodically fill and empty the peritoneum with dialysate while the patient sleeps. This machine also warms the dialysate to body temperature. What is the maximum permissible temperature for the warmed solution?. 36.6 °C. 41 °C. 18 °C. 43 °C.

What does 'inhibition' mean for an implantable pacemaker?. Positive detection of the smallest signal needed to properly control the pulse generator's function. Activation of pacemaker function upon detection of a selected signal. Blocking of pacemaker function upon detection of a selected signal. A time interval during which the pulse generator does not respond to an input signal other than the specified type.

Equivalent dose of ionizing radiation is: The product of intensity and duration of exposure. It is not defined in any way. The ratio of the average energy transferred by ionizing radiation to a substance of a given mass. It provides objectivity for comparing absorbed dose depending on radiation type and tissue.

When testing medical beds, it is checked whether the patient can get caught or trapped in any part of the bed. The test involves inserting foam objects into openings and gaps that correspond to human body proportions. These objects are defined for three body parts. Which body part is NOT among them?. Head. Chest. Neck. Foot.

The largest temperature difference occurs during ultrasonic physical therapy due to the differing impedance of tissues at the interface of these two tissues: Fat - vessel. Fat - muscle. Skin - fat. Muscle - bone.

Emissions of ionizing radiation can be caused by: Collision of two atoms of the same element. High-frequency electromagnetic fields. Spontaneous decay of atomic nuclei of natural or artificially created radionuclides. The influence of a magnetic field on atoms with an atomic number higher than 80.

An alarm whose visual and audible indication ceases when the parameter that triggered the alarm returns to a value within limits is called: Persisting alarm. Non-persisting alarm. Monitoring alarm. Technical alarm.

Which of the following does NOT occur during the interaction of ultrasound waves with tissue?. Ionizing effect. Thermal effect. Cavitation effect. Mechanical effect.

To prevent thermal imbalance in the patient during dialysis, the dialysis system is heated to a temperature close to body temperature. Standards require protection of the patient from solution temperature such that the temperature must not exceed: 18 °C. 41 °C. 43 °C. 36.6 °C.

If a device is labeled SELV, the maximum voltage expected in the circuit is: 60 V (DC). 32 V (DC). 12 V (AC). 5 V (DC).

For detachable parts of a medical bed, it is assumed that if they were too heavy, their fall could cause injury or property damage. Therefore, the standard requires that parts exceeding a certain weight must be marked with a fall hazard pictogram. From what weight does this apply?. 2 kg. 20 kg. 200 kg. 2000 kg.

The scope of validity of standards (i.e., the section titled 'scope of the standard') determines: The areas to which the standard applies. The areas to which the standard applies and the areas to which it does not apply. The areas to which the standard does not apply. Neither the areas to which the standard applies nor those to which it does not apply.

If an automated sphygmomanometer with an inflated cuff is turned off by the operator, the cuff must be deflated within a few seconds. How many seconds?. 10. 20. 60. 30.

Leakage current: Is permissible only for Type F applied parts. Is not permissible; it indicates a fault state of the device. Is not an exceptional state; it includes, for example, leakage current from a switch. Is permissible up to 100 mA.

A medical bed can be positioned in the Trenderburg position. When comparing the center of the body's circulatory system, the patient's head in this position is: Higher. Lower. At the same height. Anywhere.

Which method of preventing a patient from inhaling contaminated air should NOT be used according to the standard?. Parts coming into contact with exhaled air must be equipped with filters for bacterial/viral filtration. Parts coming into contact with exhaled air must be capable of sterilization or disinfection. Parts coming into contact with exhaled air must be washable with distilled water. Parts coming into contact with exhaled air must be disposable.

The standard for marking sphygmomanometers states that single-letter abbreviations on the device display must not be confused with SI units. Furthermore, the user expects the device to show systolic, diastolic, and mean arterial pressure. Which letter might appear on the display?. T. t. S. S.

Which mechanism does NOT participate in the fragmentation of kidney stones during ultrasonic lithotripsy?. Fatigue of material. Osmosis. Cavitation. Compression.

How high must the side rails of medical beds be, according to the standard, to prevent a patient from falling out of bed?. 2.2 mm. 22 mm. 2200 mm. 220 mm.

Safety valves for medical gases (excluding air valves) must discharge to the outside of the building. Which statement about them is NOT true?. The outlet must be distant from air inlets to the building (windows, doors, ventilation). The outlet must be grounded to protect against static electricity. The outlet must not contain shut-off valves in its path. The outlet must be protected against the ingress of, e.g., insects, biological waste, and water.

The process of killing or removing microorganisms from an environment or object, regardless of the reduction in their count, is called: Disinfection. Decontamination. Sterilization. Pasteurization.

A Type F applied part is defined as a part of the device that: We can unintentionally touch the patient with. Must never be touched by the patient under any circumstances. We can intentionally touch the patient with. We can intentionally and unintentionally touch the patient with.

The accuracy of an oximeter must be better than or equal to 4% SpO2 within a certain range, based on controlled clinical desaturation studies. What is this range?. 0% - 70%. 0% - 100%. 20% - 45%. 70% - 100%.

The largest temperature difference occurs during ultrasonic physical therapy due to the differing impedances of tissues at the interface of these two tissues: Fat - vessel. Skin - fat. Muscle - bone. Fat - muscle.

Dialysis machines are constructed with audible and visual alarms. Which type of alarm can be muted?. Visual. Both. Neither. Audible.

The normal sensitivity of an ECG device on the recording trace represents a deflection of: 10 mm/V. 100 mm/mV. 10 mm/mV. 25 mm/mV.

In a profile infusion pump, infusion to the patient is controlled by: Constantly set volume per unit time. A programmed series of different dispensing rates. Constantly set number of drops per unit time. Patient's controller and subjective state.

Equivalent dose of ionizing radiation is: The ratio of the average energy transferred by ionizing radiation to a substance of a given mass. It is not defined in any way. The product of intensity and duration of exposure. It provides objectivity for comparing absorbed dose depending on radiation type and tissue.

According to the standard for medical beds, the spacing between movable parts of the bed in the normal use position must be either sufficiently small or sufficiently large to prevent entrapment of body parts. For which spacing values does the bed meet the standard's requirements?. Less than 80 mm, or greater than 250 mm. Less than 8 mm, or greater than 25 mm. Less than 0.8 mm, or greater than 2.5 mm. Less than 800 mm, or greater than 2500 mm.

Materials for pipeline distribution systems must withstand corrosion and be compatible with the conveyed gas. What is the best material for constructing medical gas pipeline systems?. Zinc. Surgical steel. Copper. Aluminum.

A set of measures leading to the killing of microorganisms to interrupt the transmission of infection from a source to a susceptible individual is called: Pasteurization. Sterilization. Disinfection. Disinsection.