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

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	3 dB _________  5 dB
2. Medical scales	human weight	weight (kg)	human weight measurement	0.5 to 15 kg inclusive _________ over 15 to 150 kg	0.01 kg _________  0.1 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	5%
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	3% for external exposure __________  5% for intrathecal and cavity irradiation
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)	15%
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	20%
7. Medical devices for research of parameters of external respiration (spirographs, pneumotachographs, etc.)	inhaled (exhaled) air flow volumes and velocities	gas volume (l) _________ gas flow rate (l/s)	measurement of inhaled (exhaled) air volume ______________ measurement of breathing air volume discharges	0.2 to 8.0 liters ___________ 0.4 to 12.0 l/s	3% __________  5%
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 _______________ carbon dioxide _______________ measurement of the mass vapor content of ethanol in exhaled air	5% to 25% inclusive ___________ over 25% to 100% ___________ from 0% to 4% inclusive ___________ over 4% to 15% ___________ 0 to 0.5 mg/l inclusive ___________ over 0.5 to 0.95 mg/l	1% __________  3% __________  0,01% __________  0,5% __________  0.05 mg/l __________  10%
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 ___________ prismatic action from 0.5 to 10.0 dpt.	0,06 … 0.25 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	10%
11. Medical height gauge	human growth	length (cm)	human height measurement	30 to 200 cm	0.5 cm.
12. Medical thermometer	temperature (°C)		body temperature measurement	32 to 42 °C inclusive	0,1 °C
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.	3 mm Hg.
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	0.06 OP units __________  0.6 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	2% __________  3% __________  5%

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.