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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 12, 2016 №42

About approval of the list of types of the medical products which are subject to reference in case of their registration to measuring instruments

According to article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, Item 110 of appendix №1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 №98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 №109 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission DECIDED:

1. Approve the enclosed list of types of the medical products which are subject to reference in case of their registration to measuring instruments.

2. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Members of council of the Eurasian economic commission:

From the Republic of Armenia 

 

V. Gabriyelyan

From the Republic of Belarus

V. Matyushevsky

From the Republic of Kazakhstan

B. Sagintayev

From the Kyrgyz Republic

O. Pankratov

From the Russian Federation

I. Shuvalov

 

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 №42

The list of types of the medical products which are subject to reference in case of their registration to measuring instruments

Type of medical product

The medical characteristics and sizes determined with use of measurements

Names of the measured sizes, units

Measurements

Measuring range

Maximum permissible error

1

2

3

4

5

6

1. Audiometer medical

characteristics of the acoustic analyzer of the patient: intensity of test tone sound signals of different frequencies in case of air and bone sound carrying out

intensity of sound (dB)

measurement of intensity of test tone sound signals of different frequency in case of air and bone sound carrying out

от 125 до 4000 Hz inclusive

±3 dB

over 4000 to 8000 Hz

±5 dB

2. Scales medical

weight (weight) of the person

weight (kg)

measurement of mass of the person

from 0,5 to 15 kg inclusive

±0,01 kg

over 15 to 150 kg

±0,1 kg

3. Dynamometer medical

force developed by any group of muscles of the person

force it (is this)

measurement of force developed by any group of muscles of the person

from 5 to 500 it is this

±5 %

4. The dosimeter clinical universal for radiation therapy

dose characteristics of photon and electronic radiation in case of radiation therapy

absorbed dose (Gr),
capacity of absorbed dose (Gr / c),
energy (MEV) of radiation

measurement of absorbed dose in water, absorbed dose in biological fabric, kermas in air in case of radiation therapy

from 0,5 to 10,0 of Gr

±3 % in case of external radiation

±5 % in case of interstitial and band radiation

5. X-ray dosimeter clinical 

dose characteristics of radiation in case of X-ray diagnostic testings

absorbed dose in air (Gr),
capacity of absorbed dose (Gr x cm 2)

measurement of absorbed dose in case of X-ray diagnostic testings:
in biological fabric;
kermas in air

from 5·10-6 to 0,2 of Gr

±15 %

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