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All measuring devices which are integral part of medical equipment that is used on a daily basis in the healthcare system, include some safety risks. In addition to knowledge and experience of doctors and medical staff, verification of these devices is important because measurements gained from these devices play important role in diagnosis, treatment and monitoring of patients.

 

The regulatory body INSLAB d.o.o. Belgrade is equipped with highly sophisticated equipment from world-renowned manufacturers Fluke Biomedical, MesaLabs and OHMIC Instruments Inc.

The regulatory body INSLAB d.o.o. Belgrade hires staff trained to perform verification activities.


Verification of measuring devices that are an integral part of

ANESTHESIOLOGICAL SYSTEMS

An anesthesiologic system is a system of continuous flow, volume and pressure that is designed to provide an accurate and continuous supply of medical gases, mixed with a precise concentration of anesthetic vapor (such as sevorane). Its purpose is to deliver it to the patient at safe pressure, volume and flow.

The manner, conditions of periodic and extraordinary verifications, as well as the requirements that measuring devices in anesthesiologic systems must meet, are prescribed by the Rulebook on verification of measuring devices that are an integral part of anesthesiologic systems ("Official Gazette of RS" No. 92/2020).

Verification of measuring devices that are an integral part of anesthesiologic systems is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 - Fluke Biomedical ESA 620.
  • Reference standard for measuring flow, pressure, volume, oxygen concentration and anesthetic gases – Fluke Biomedical VT900A + VAPOR.

Verification of measuring devices that are an integral part of

DEFIBRILLATORS

A defibrillator is an electrical device used to defibrillate the heart in cases of sudden cardiac arrest by releasing controlled electrical energy (electric shock) to the heart through the chest in order to restore heart function.

The manner, conditions of periodic and extraordinary verifications, as well as the requirements that measuring devices must meet in defibrillators, are prescribed by the Rulebook on verification of measuring devices that are an integral part of defibrillators ("Official Gazette of RS" No. 92/2020).

Verification of measuring devices that are an integral part of the defibrillator is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 – Fluke Biomedical ESA 620.
  • Reference standard for measuring electricity output – Fluke Biomedical Impulse 7000 DP.

Verification of measuring devices that are an integral part of

DIALYSIS DEVICES

A dialysis device is an electric automatic device which is used for hemodialysis. Hemodialysis is a process that represents the exchange between the patient's blood and the electrolyte solution in which waste products are removed from the patient's blood and almost normal electrolyte balance is established.

The manner, conditions of periodic and extraordinary verification, as well as the requirements that measuring devices for dialysis devices must meet, are prescribed by the Rulebook on verification of measuring devices that are an integral part of dialysis devices ("Official Gazette of RS" No. 92/2020).

Verification of measuring devices that are an integral part of dialysis devices is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 – Fluke Biomedical ESA 620.
  • Reference standard for measuring conductance and temperature – MesaLabs 90XL Meter.

Verification of

ELECTROCARDIOGRAPH

An electrocardiograph (ECG) is an electrical device that records and displays electrical signals of heart's potential from the surface of the body as a function of time. The record of cardiac activity is called an electrocardiogram.

The manner, conditions of periodic and extraordinary verification, as well as requirements that electrocardiographs must meet, are prescribed by the Rulebook on certification of electrocardiographs ("Official Gazette of RS" No. 92/2020).

Electrocardiograph verification is performed by trained staff of INSLAB d.o.o. Belgrade.

Test equipment:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 – Fluke Biomedical ESA 620.
  • Reference standard for measuring voltage and heart rate – Fluke Biomedical ProSim 8-01 Vital Signs Simulator.

Verification of measuring devices that are an integral part of

INFUSION AND PERFUSION PUMPS

An infusion pump is a medical electrical device designed to regulate the flow of fluid that enters a patient under a certain pressure created by the action of gravitational force.

A perfusion pump is a medical electrical device designed to regulate the flow of fluid that goes into a patient under a certain pressure created by the pump.

The manner, conditions of periodic and extraordinary verification, as well as the requirements that measuring devices for infusion and perfusion pumps must meet, are prescribed by the Rulebook on verification of measuring devices that are an integral part of infusion and perfusion pumps ("Official Gazette of RS" No. 92/2020).

Verification of measuring devices that are an integral part of infusion and perfusion pumps is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 – Fluke Biomedical ESA 620.
  • Reference standard for measuring flow - Fluke Biomedical IDA-5/4.

Verification of measuring devices that are an integral part of

HIGH FREQUENCY SURGICAL KNIVES AND HIGH FREQUENCY SURGICAL ACCESSORIES

A high-frequency surgical knife is a medical electrical device with accompanying equipment intended for performing surgical operations, such as cutting or coagulating biological tissue using high-frequency currents.

High-frequency surgical accessories are accessories intended for handling, replenishing and monitoring HF energy applied to a patient with a HF surgical knife.

The manner, conditions of periodic and extraordinary verification, as well as the requirements that measuring devices that are an integral part of high-frequency surgical knives and high-frequency surgical accessories must meet, are prescribed by the Rulebook on verification of measuring devices that are an integral part of high-frequency surgical knives (“Official Gazette of RS" No. 92/2020).

Verification of measuring devices that are an integral part of high-frequency surgical knives and high-frequency surgical accessories is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 – Fluke Biomedical ESA 620.
  • Reference standard for measuring electrical power and current output - Fluke Biomedical QA-ES MK III-01.

Verification of measuring devices that are an integral part of

NEONATAL AND PEDIATRIC INCUBATORS AND RESUSCITATION WARM TABLES

An incubator for newborns is a medical electrical device equipped with a compartment that has options for controlling the environmental conditions in which the newborn is. It is primarily done with the help of heated air in the compartment. There are stationary and transport incubators. Transport incubators are equipped with a compartment and a transportable power source.

The manner, conditions of periodic and extraordinary verification, as well as the requirements which measuring devices that are an integral part of the incubator must meet, are prescribed by the Rulebook on verification of measuring devices that are an integral part of neonatal and pediatric incubators and resuscitation warm tables. (“Official Gazette of RS" No. 92/2020).

Verification of measuring devices which are an integral part of neonatal and pediatric incubators and resuscitation warm tables is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 – Fluke Biomedical ESA 620.
  • Reference standard for measuring air temperature, relative humidity, air flow rate, time and noise levels – Fluke Biomedical INCU II-BT II.

Verification of measuring devices that are an integral part of

ULTRASOUND DEVICES FOR PHYSICAL THERAPY

An ultrasonic physiotherapy device is an electrical device which, through a probe, generates an ultrasound signal for the purposes of therapeutic treatment.

The manner, conditions of periodic and extraordinary verification, as well as the requirements which measuring devices for ultrasonic physiotherapy devices must meet, are prescribed by the Rulebook on verification of measuring devices that are an integral part of ultrasonic physiotherapy devices ("Official Gazette of RS" No. 92/2020).

Verification of measuring devices which are an integral part of ultrasonic devices for physical therapy is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 – Fluke Biomedical ESA 620.
  • Reference standard for measuring power with water tank – Ohmico Instruments UPM-DT-1000PA.

Verification of measuring devices that are an integral part of

VENTILATORS

A ventilator is an electric automatic device with a connection for supplying air to the patient. It maintains the breathing function or increases the patient's ability to breathe.

The manner, conditions of periodic and extraordinary verification, as well as the requirements which measuring devices for ventilators must meet, are prescribed by the Rulebook on verification of measuring devices that are an integral part of ventilators ("Official Gazette of RS" No. 92/2020).

Verification of measuring devices which are an integral part of ventilators is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 – Fluke Biomedical ESA 620.
  • Reference standard for measuring flow, pressure, volume and oxygen concentration – Fluke Biomedical VT900A.

Verification of measuring devices that are an integral part of

MULTIFUNCTIONAL DEVICES FOR PATIENT MONITORING

A multifunctional device for patient monitoring is a modular or pre-configured device that includes more than one physiological monitoring unit. These units are designed to generate alarms and collect information from a patient in order to process that information for monitoring purposes.

The manner, conditions of periodic and extraordinary verification, as well as the requirements that measuring devices for multifunctional devices for patient monitoring must meet, are prescribed by the Rulebook on verification of measuring devices that are an integral part of multifunctional devices for patient monitoring (Official Gazette of RS No. 92 / 2020).

Verification of measuring devices that are an integral part of multifunctional devices for patient monitoring is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference standard for testing electrical safety in accordance with the standard SRPS EN 60601-1 – Fluke Biomedical ESA 620.
  • Reference standard for measuring blood oxygen saturation, respiration, blood pressure and heart rate Fluke Biomedical ProSim 8.

Verification of

MANOMETERS FOR MEASURING BLOOD PRESSURE

which are used for health protection in healthcare institutions

Blood pressure is the pressure in the arterial system of the human body which can be measured with a manometer for measuring blood pressure. Blood pressure measurement can be invasive or non-invasive (indirect blood pressure measurement without penetrating the artery).

Types of manometers:

  • mechanical manometers (mercury medical manometers, aneroid gauges with elastic measuring element);
  • electromechanical manometers and measuring systems for measuring blood pressure.

The manner, conditions of periodic and extraordinary verification, as well as the requirements that the manometer must meet, are prescribed by the Guidelines on verification of manometers for measuring blood pressure ("Official Gazette of RS" No. 88/2019).

Certification of manometers for measuring blood pressure is performed by trained staff of INSLAB d.o.o. Belgrade.

Equipment for testing:

  • Reference pressure standard – Fluke Biomedical ProSim 8-01 Vital Signs Simulator.

The Ministry of Economy, in accordance with Article 19 of the Law on Metrology ("Official Gazette of RS" 15/16) and with the purpose of citizen’s protection and general safety prescribed the obligation to verify medical measuring devices in RULEBOOK ON TYPES OF MEASURING DEVICES WHICH ARE SUBJECT TO LEGAL CONTROL ("Official Gazette of RS", no. 37/2021 and 84/2022) as follows:

Measuring devices for anesthesiologic systems (download Rulebook “Official Gazette of RS” No. 92/2020))

Measuring devices for defibrillators (download Rulebook “Official Gazette of RS” No. 92/2020))

Measuring devices for dialysis devices (download Rulebook “Official Gazette of RS” No. 92/2020))

Measuring devices for electrocardiograph (download Rulebook “Official Gazette of RS” No. 92/2020))

Measuring devices for neonatal and pediatric incubators and resuscitation warm tables (download Rulebook “Official Gazette of RS” No. 92/2020))

Measuring devices for multifunctional devices for patient monitoring (download Rulebook “Official Gazette of RS” No. 92/2020))

Measuring devices for perfusion and infusion pumps (download Rulebook “Official Gazette of RS” No. 92/2020))

Measuring devices for high-frequency surgical knives and high-frequency surgical accessories (download Rulebook “Official Gazette of RS” No. 92/2020))

Measuring devices for mechanical ventilators or ventilators (download Rulebook “Official Gazette of RS” No. 92/2020))

Measuring devices for ultrasonic devices for physiotherapy (download Rulebook “Official Gazette of RS” No. 92/2020))

Manometers for measuring blood pressure which are used for health protection in health care institutions (download Rulebook "Official Gazette of RS" No. 88/2019))