June 28, 2018
Climatic zone classification for medical devices
There is a standard GOST 15150 in Russian Federation, which regulates climatic conditions of manufactured devices. It contains normative values of ambient temperatures for different modifications of devices for different climatic areas.
According to GOST R 50444 medical devices must comply with requirements of one of these climatic conditions: УХЛ4.2 (English abbreviation see in table below), У1, У1.1, У2, У3, У5, Т1, Т1.1, Т2, Т3, Т5, О4.1 and О4.2.
But it’s legal, if customer ask manufacturer device with other climatic condition. There is the table contains data for all the climatic modification.
Table 1 – Normative values of ambient climatic factors for different climatic modifications (Table in separate page by link)
| Russian abbreviation | English abbreviation | Climate | Device category | Ambient temperature during exploitation, °С | Source standard | |||
| Working range | Maximal working range | |||||||
| Upper | Lower | Upper | Lower | |||||
| ХЛ | F | Frigid | 1; 1,1; 2; 2,1; 3 | 40 | -60 | 45 | -70 | GOST 15150 |
| 3,1 | 40 | -10 | 45 | -10 | ||||
| 5; 5,1 | 35 | -10 | 35 | -10 | ||||
| УХЛ | NF | Temperate, Frigid | 1; 1,1; 2; 2,1; 3 | 40 | -60 | 45 | -70 | GOST 15150 |
| 3,1 | 40 | -10 | 45 | -10 | ||||
| 4 | 35 | 1 | 40 | 1 | ||||
| 4,1 | 25 | 10 | 40 | 1 | ||||
| 4,2 | 35 | 10 | 40 | 1 | ||||
| 5; 5,1 | 35 | -10 | 35 | -10 | ||||
| У | N | Temperate | 1; 1,1; 2; 2,1; 3 | 40 | -45 | 45 | -50 | GOST 15150 |
| 3,1 | 40 | -10 | 45 | -10 | ||||
| 5; 5,1 | 35 | -5 | 35 | -5 | ||||
| УТ | NT | Temperate, tropical | 1; 1,1; 2; 2,1; 3 | 40 | -45 | 45 | -50 | GOST 15150 |
| 3,1 | 40 | -10 | 45 | -10 | ||||
| 5; 5,1 | 35 | -5 | 35 | -5 | ||||
| Т | T | Arid and humid tropical | 1; 1,1; 2; 2,1; 3; 3,1 | 50 | -10 | 60 | -10 | GOST 15150 |
| 4 | 45 | 1 | 55 | 1 | ||||
| 4,1 | 25 | 10 | 40 | 1 | ||||
| 4,2 | 45 | 10 | 45 | 10 | ||||
| 5; 5,1 | 35 | 1 | 35 | 1 | ||||
| ТС | TA | Tropical arid | 1; 1,1; 2; 2,1; 3; 3,1 | 50 | -10 | 60 | -10 | GOST 15150 |
| 4 | 45 | 1 | 55 | 1 | ||||
| 4,1 | 25 | 10 | 40 | 1 | ||||
| 4,2 | 45 | 10 | 45 | 10 | ||||
| 5; 5,1 | 35 | 1 | 35 | 1 | ||||
| ТВ | TH | Tropical humid | 1; 1,1; 2; 2,1; 3; 3,1 | 40 | 1 | 45 | 1 | GOST 15150 |
| 4 | 40 | 1 | 1 | |||||
| 4,1 | 25 | 10 | 45 | 1 | ||||
| 4,2 | 45 | 10 | 45 | 10 | ||||
| 5; 5,1 | 35 | 1 | 35 | 1 | ||||
| О | U | Universal except the antarctical | 1; 1,1; 2; 2,1 | 50 | -60 | 60 | -70 | GOST 15150 |
| 4 | 45 | 1 | 55 | 1 | ||||
| 4,1 | 25 | 10 | 40 | 1 | ||||
| 4,2 | 45 | 10 | 45 | 1 | ||||
| 5; 5,1 | 35 | -10 | 35 | -10 | ||||
| М | M | Marine | 1; 1,1; 2; 2,1; 3; 5; 5,1 | 40 | -40 | 45 | -40 | GOST 15150 |
| 4; 3,1 | 40 | -10 | 40 | -10 | ||||
| 4,1 | 35 | 15 | 40 | 1 | ||||
| 4,2 | 40 | 1 | 40 | 1 | ||||
| ТМ | MT | Marine tropical + cabotage ships | 1; 1,1; 2; 2,1; 3; 5; 5,1 | 45 | 1 | 45 | 1 | GOST 15150 |
| 4 | 45 | 1 | 45 | 1 | ||||
| 4,1 | 25 | 10 | 40 | 1 | ||||
| 4,2 | 45 | 1 | 45 | 1 | ||||
| ОМ | MU | Marine universal | 1; 1,1; 2; 2,1; 3; 5; 5,1 | 45 | -40 | 45 | -40 | GOST 15150 |
| 4; 3,1 | 45 | -10 | 45 | -10 | ||||
| 4,1 | 35 | 15 | 40 | 1 | ||||
| 4,2 | 40 | 1 | 40 | 1 | ||||
| В | W | Worldwide | 1; 1,1; 2; 2,1; 3 | 50 | -60 | 60 | -70 | GOST 15150 |
| 3,1 | 50 | -10 | 55 | -10 | ||||
| 4 | 45 | -10 | 55 | -10 | ||||
| 4,1 | 25 | 10 | 40 | 1 | ||||
| 4,2 | 45 | 1 | 45 | 1 | ||||
| 5; 5,1 | 45 | -40 | 45 | -40 | ||||
