Decision of the Board of the Eurasian Economic Commission dated February 12, 2016 No. 42
"On the Approval of the List of Types of Medical Devices Subject to Classification as Measuring Instruments During Their Registration"
COUNCIL OF THE EURASIAN ECONOMIC COMMISSION
DECISION
dated February 12, 2016. N 42
ON THE APPROVAL OF THE LIST
TYPES OF MEDICAL DEVICES SUBJECT TO CLASSIFICATION
AT THEIR REGISTRATION TO MEASURING INSTRUMENTS
In accordance with Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, Article 4 of the Agreement on common principles and rules of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 110 of Annex N 1 to the Regulations of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98, and Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 109 "On the implementation of the Agreement of the Eurasian Economic Union of December 23, 2014".
1. To approve the attached list of types of medical devices subject to classification as measuring instruments during their registration.
2. This Decision shall enter into force upon expiration of 10 calendar days from the date of entry into force of the Protocol signed on December 2, 2015, on the accession of the Republic of Armenia to the Agreement on Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than upon expiration of 10 calendar days from the date of official publication of this Decision.
Members of the Council of the Eurasian Economic Commission:
Approved
By the decision of the Council of the Eurasian
economic commission
dated February 12, 2016. N 42
LIST
TYPES OF MEDICAL DEVICES SUBJECT TO CLASSIFICATION
AT THEIR REGISTRATION TO MEASURING INSTRUMENTS
From the
Republic of Armenia
V.GABRIELYAN
From the
Republic of Belarus
V.MATYUSHEVSKY
From the
Republic of Kazakhstan
B. SAGINTAEV
From the
Kyrgyz Republic
O. PANKRATOV
From the
Russian Federation
I. SHUVALOV
| Type of medical device | Medical characteristics and values determined using measurements | Names of measured quantities, units | Measurements | Measuring range | Maximum permissible error |
| 1 | 2 | 3 | 4 | 5 | 6 |
| 1. Medical audiometer | characteristics of the patient's auditory analyzer: intensity of test tones of different frequencies in air and bone sound conduction | sound intensity (dB) | measuring the intensity of test tones of different frequencies at air and bone sound conduction | 125 to 4000 Hz inclusive |
|
| over 4000 to 8000 Hz |
| ||||
| 2. Medical scales | human weight | weight (kg) | human weight measurement | 0.5 to 15 kg inclusive |
|
| over 15 to 150 kg |
| ||||
| 3. Medical dynamometer | the force developed by a group of muscles in a person | force (daN) | A measurement of the force developed by a human muscle group | 5 to 500 daN |
|
| 4. Clinical universal dosimeter for radiation therapy | Dose characteristics of photon and electron radiation in radiation therapy | absorbed dose (Gy), absorbed dose rate (Gy/s), energy (MeV) of radiation | measurement of absorbed dose in water, absorbed dose in biological tissue, kerma in air during radiation therapy | 0.5 to 10.0 Gy |
|
|
| |||||
| 5. Clinical X-ray dosimeter | Dose characteristics of radiation in X-ray diagnostic examinations | absorbed dose in air (Gy), absorbed dose rate (Gy x cm2) | Absorbed dose measurement in X-ray diagnostic studies: in biological tissue; kermas in the air | 5 - 10-6 to 0.2 Gy |
|
| 1 - 10-6 to 10 Gy x m2 |
| ||||
| 3 -10-5 to 50 Gy x cm2 (for computed x-ray tomography) |
| ||||
| 6. Photon radiation dosimeter for radiation monitoring at personnel workplaces | dose characteristics of photon radiation at personnel workplaces | absorbed dose (Sv) of photon radiation | Measurement of dose equivalents (ambient, directed) at personnel workplaces and individual dose equivalent for personnel | 1 - 10-6 to 10 Sv |
|
| 7. Medical devices for research of parameters of external respiration (spirographs, pneumotachographs, etc.) | inhaled (exhaled) air flow volumes and velocities | gas volume (l) | measurement of inhaled (exhaled) air volume | 0.2 to 8.0 liters |
|
| gas flow rate (l/s) | measurement of breathing air volume discharges | 0.4 to 12.0 l/s |
| ||
| 8. Medical devices for research of inhaled and exhaled air composition (oximeters, capnometers, alcometers) | concentrations: oxygen (oximetry), carbon dioxide (capnometry), ethanol vapor (alcometry) | concentration (%) or mass content (mg/l) of the substance | measurement of concentration or quantitative content of oxygen and carbon dioxide in inhaled (or) exhaled air (artificial gas respiratory mixture) under normobaric conditions: |
|
|
| oxygen | 5% to 25% inclusive |
| |||
| over 25% to 100% |
| ||||
| carbon dioxide | from 0% to 4% inclusive |
| |||
| over 4% to 15% |
| ||||
| measurement of the mass vapor content of ethanol in exhaled air | 0 to 0.5 mg/l inclusive |
| |||
| over 0.5 to 0.95 mg/l |
| ||||
| 9. Set of trial spectacle lenses | changes in the characteristics of the visual apparatus (nearsightedness, farsightedness, strabismus, astigmatism, etc.). | optical power (dpt) | Measurement of changes in the characteristics of the visual apparatus by means of the optic-physical characteristics of trial spectacle lenses | optical power from -20.0 to +20.0 dptr | 0,06 ... 0.25 dpt |
| prismatic action from 0.5 to 10.0 dpt. | 0,2 ... 0.3 dpt | ||||
| 10. Clinical radiometer | activity of radioactive preparations used for biomedical research, diagnosis and treatment of diseases | radionuclide radioactivity (Bq) | measurement of radionuclide activity in preparations used for microbiological research, diagnosis and treatment of diseases | 103 to 1010 Bq |
|
| 11. Medical height gauge | human growth | length (cm) | human height measurement | 30 to 200 cm |
|
| 12. Medical thermometer | human body temperature | temperature (°C) | body temperature measurement | 32 to 42 °C inclusive |
|
| 13. Medical tonometer, except for patient monitoring systems with built-in blood pressure channel | systolic and diastolic blood pressure values | measurement of excess air pressure in the compression cuff (mmHg). | Blood pressure measurement (non-invasive) | 40 to 250 mmHg. |
|
| 14. Photometer, spectrophotometer. photocolorimeter medical for clinical laboratory diagnostics | concentration of substances, enzyme activity in liquid biological samples | optical density of solutions of the tested substances (OD units) | measurement of optical density values with subsequent conversion of the measured value into the required parameter in accordance with the research methodology | 0 to 2 OP units inclusive |
|
| over 2 to 4 OP units |
| ||||
| 15. Medical ergometer | moderate physical activity | mechanical power (W) | measurement of power-dosed physical activity | 7 to 100 W inclusive |
|
| over 100 W up to and including 500 W |
| ||||
| over 500 to 1000 W |
|
Notes:
1. Medical devices subjected to type-approval testing shall meet the requirements in terms of measuring range and maximum permissible error, taking into account their intended use.
2. Updating of the List of types of medical devices to be classified as measuring instruments during their registration shall be carried out on the basis of proposals of the authorized bodies of the member states of the Eurasian Economic Union in accordance with the procedure established by the Regulations of the Eurasian Economic Commission approved by the Decision of the Supreme Eurasian Economic Council dated December 23, 2014 N 98.
