Which medical devices are measuring medical devices?
Medical devices with measuring function require additional testing during registration process. How manufacturer could know that his device is measuring medical device? See answer from Order of Ministry of Health of the Russian Federation #89n dated August 15, 2012 (Appendix 2).
LIST OF MEDICAL PRODUCTS CLASSIFIED AS MEASURING DEVICES IN STATE REGULATION OF UNIFORMITY OF MEASUREMENTS AND TESTED TO ESTABLISH THE TYPES OF MEASURING DEVICES:
| No. | Medical product names | Medical features and values determined using measurements | Names (units) of measured values |
| 1 | Medical thermometers | Human body temperature | Temperature (°C) |
| 2 | Medical scales | Human weight | Weight (kg) |
| 3 | Height meters | Human height | Linear size (cm) |
| 4 | Medical dynamometers | Force developed by any group of muscles | Strength (daN) |
| 5 | Medical ergometers | Physical exertion dosed by capacity | Mechanical output (W) |
| 6 | Medical pulsimeters (tonometers) | Values of systolic and diastolic blood pressure | Gas pressure in the air gasket, with recording of the pressure micropulsation intensity (mm Hg) |
| 7 | Medical products to test the external respiration parameters (spirographs, pneumotachographs etc.) | Volumes and flow speeds of inhaled/ exhaled air | Gas volume (ml) Gas flow speed (l/s) |
| 8 | Medical products to test the composition of inhaled/exhaled air (oximeters, carbonometers, alcohol testers) | Concentrations: oxygen (oxymetry), carbon dioxide (carbonometry), air ethanol (alcohol testing) | Percentage or quantitative content of oxygen, carbon dioxide, air ethanol in inhaled and/or exhaled air |
| 9 | Sets of spectacle lens | Impairment of vision (myopia, hyperopia, heterotropy, astigmia etc.) | Optical strength (diopter) and other optical and physical values |
| 10 | Medical audiometers | Acoustic analyzer parameters | Intensity of test aural tones (dB) of different frequency in air and bone conduction |
| 11 | Clinical multipurpose dosimeters for X-ray therapy | Dose parameters of photon and electron emissions in X-ray therapy | Absorbed dose(Gr), dose rate (Gr/s), radiation energy (MeV) |
| 12 | Clinical X-ray dosimeters | Dose parameters of radiation in X-ray imaging | Absorbed dose (Gr), dose rate (Gr/s), the absorbed dose multiplied by the beam area (cGr/sGr x cm2) |
| 13 | Photon emission dosimeters for radiation control at personnel workstations | Dose parameters of photon emissions at personnel workstations | Absorbed dose (μSv), dose rate (μSv/h) of photon emission |
| 14 | Clinical radiometers | Activity of radioactive drugs used in medical biological tests, disease diagnosis and treatment | Radioactivity of gamma ray radionuclides (Bq, Cu) |
| 15 | Medical laboratory photometers, spectrophotometers, photocolorimeters | Concentration of substances and activity of ferments in liquid biological samples | Optical density of solutions of tested substances (units of optical density) |